Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients with Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization or egg freezing. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of eggs retrieved.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Southern California

CTRI/2024/10/075753

/ Not yet recruitingPhase 2/3IIT

Evaluation of comparative efficacy of Rasona Ksheerapaka versus Clomiphene Citrate in the management of anovulation induced infertility - RCT - NIL

Start Date05 Nov 2024

Sponsor / Collaborator-

NCT06635538

/ RecruitingNot ApplicableIIT

One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile

The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).

Start Date31 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Clomiphene Citrate

100 Translational Medicine associated with Clomiphene Citrate

100 Patents (Medical) associated with Clomiphene Citrate

3,937

Literatures (Medical) associated with Clomiphene Citrate

01 Feb 2025·Biochemical Pharmacology

The TFEB activator clomiphene citrate ameliorates lipid metabolic syndrome pathology by activating lipophagy and lipolysis

Article

Author: Li, Wei ; Li, Yuyin ; Huang, Chunhuan ; Liu, Jiamiao ; Diao, Aipo ; Liu, Zhenxing ; Li, Lu ; Yuan, Yi ; Lin, Jieru

The balance between lipid synthesis and lipid catabolism is critical to maintain energy homeostasis. Lipophagy and lipolysis are two important pathways for lipid selective catabolism. Defects in lipophagy and lipolysis are linked to lipid metabolic diseases. Transcription factor EB (TFEB) is a master regulator of autophagy and lysosome biogenesis, as well as lipid metabolism by promoting expression of genes encoding fat catabolic lipases. Therefore, targeting TFEB provides a novel potential strategy for the treatment of lipid metabolic diseases. In this study, we showed that the TFEB activator clomiphene citrate (CC) activated the autophagy-lysosome and lipolysis pathways, and promoted degradation of lipid droplets induced by the free fatty acids oleate and palmitate in HepG2 cells. Moreover, CC treatment promoted lipid catabolism and attenuated obesity, restored lipid levels, blood glucose levels and insulin resistance, hepatocellular injury and hepatic steatosis, as well as liver inflammation in the HFD fed mice. In addition, we found that En-CC, a trans-isomer of CC, displayed less toxicity and more efficient activation of TFEB. Consistent with CC, En-CC treatment improved lipid metabolic syndrome pathology. These findings demonstrate that CC promotes clearance of lipids and ameliorates HFD-induced lipid metabolic syndrome pathology through activating TFEB-mediated lipophagy and lipolysis, indicating that CC has the potential to be used to treat lipid metabolic diseases.

01 Jan 2025·Journal of Obstetrics and Gynaecology Research

EXPRESSION OF CONCERN: Combined Metformin and Clomiphene Citrate Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene‐Resistant Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial

31 Dec 2024·Journal of Obstetrics and Gynaecology

Statement of retraction: Clomiphene citrate or aromatase inhibitors combined with gonadotropins for superovulation in women undergoing intrauterine insemination: a prospective randomised trial

News (Medical) associated with Clomiphene Citrate

16 Oct 2024

·www.globenewswire.com

KYZATREX® (testosterone undecanoate) CIII Capsules Featured in Research at the Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting

RALEIGH, N.C., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce that KYZATREX® (testosterone undecanoate) CIII capsules will be highlighted in three research abstracts at the upcoming Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting taking place from October 17th to 20th in Scottsdale, Arizona. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The abstracts being presented include: "Combined Clomiphene and High-Dose Oral Testosterone Therapy in Hypogonadal Men: A Case Series" – This study, conducted by Dr. Andrew Sun, Grace Yoon BS, and Jimmy Vo BS, explores the effects of combining clomiphene with high-dose oral testosterone therapy, highlighting a novel approach to optimizing treatment outcomes for hypogonadal men. Dr. Sun will present this abstract."Initiating High-Dose Oral Testosterone Undecanoate Therapy in Hypogonadal Men" – This research, conducted by Dr. Andrew Sun, Jimmy Vo BS, and Grace Yoon BS, focuses on the initiation process for high-dose oral testosterone undecanoate therapy, offering valuable data for clinicians considering this treatment option for men with testosterone deficiency. Dr. Sun will present this abstract."Effects of Oral Testosterone Undecanoate on Semen Parameters in Hypogonadal Men: An Interim Analysis of a Prospective Pilot Study" – Presented by Gal Saffati, this study examines the impact of oral testosterone undecanoate on semen parameters, providing new insights into its effects on fertility in hypogonadal men. “We are proud to see KYZATREX featured in these important studies at the SMSNA Annual Meeting, contributing to a deeper understanding of testosterone therapy and its potential benefits for men with hypogonadism,” said Amit Shah, COO of Marius Pharmaceuticals. “These findings highlight the value of exploring new avenues in oral testosterone treatment.” The SMSNA Annual Fall Scientific Meeting gathers leading experts in sexual medicine, providing a platform for sharing innovative research and best practices. Marius Pharmaceuticals remains committed to advancing the science of testosterone therapy and improving outcomes for patients with testosterone deficiency. About KYZATREX® (testosterone undecanoate)KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius PharmaceuticalsMarius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com. Important Safety Information for KYZATREX® (testosterone undecanoate)UseKYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.Important Safety Information for KYZATREX® (testosterone undecanoate) KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.If your blood pressure cannot be controlled, KYZATREX may need to be stopped.Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.Increased risk of prostate cancer.Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.In large doses, KYZATREX may lower your sperm count.Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).Swelling of your ankles, feet, or body (edema), with or without heart failure.Enlarged or painful breasts.Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above.The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children.See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact: Lilly Washburnlilly@mariuspharma.com

Clinical ResultPhase 3

19 Jul 2024

·www.outsourcing-pharma.com

Avista and Hamilton Lane Join Forces to Propel Growth and Innovation at Cosette Pharmaceuticals

The companies will jointly control Cosette, with a focus on accelerating innovation and growth. Since Avista's initial investment in Cosette in December 2018, Cosette has launched new products through research and development efforts, acquisitions, and licensing deals. This includes the acquisition of Ambien and Ambien CR in the United States from Sanofi US. The company reports that these initiatives have led to significant EBITDA growth and free cash flow generation, positioning Cosette for future opportunities. Apurva Saraf, president and CEO of Cosette, said: “This partnership is a testament to the remarkable transformation our business has achieved over the past four years, driven by an unwavering commitment to strategic business development and operational excellence. I am immensely proud of the entire Cosette team for their dedication in delivering this robust growth. “We have successfully diversified our portfolio with branded products such as Clomid, Ambien, and Benicar, along with innovative, patent-protected drugs like Vyleesi and Intrarosa. With our strong R&D and business development pipeline, we are well positioned to drive substantial growth in partnership with Avista and Hamilton Lane." Financial strength and future opportunities for Cosette Pharmaceuticals The companies indicate that this transaction will enhance Cosette's balance sheet and support growth through investments in R&D and strategic acquisitions. The goal is to build a durable, high-growth, branded pharmaceutical company. As part of the transaction, Cosette has also secured a new term loan financing with Hayfin Capital Management and a new revolving credit facility provided by UBS Investment Bank, Capital One, National Association, and Santander Corporate & Investment Bank, who acted as joint lead arrangers and joint bookrunners for the financing. googletag.cmd.push(function () { googletag.display('text-ad1'); }); David Burgstahler, managing partner and CEO of Avista, added: “We value Avista's long-term relationship with Hamilton Lane and look forward to collaborating with them as a strategic partner to drive growth and value at Cosette. Our collective expertise will prove invaluable as Cosette evaluates larger M&A opportunities as part of the company's growth strategy.” Cosette Pharmaceuticals has made significant contributions to the pharmaceutical industry, particularly in the realm of specialty pharmaceuticals. The company has a strong focus on developing and commercializing branded and generic products that address unmet medical needs. With a diverse portfolio that includes notable products, Cosette has demonstrated a commitment to innovation and patient care. It says its strategic approach to research and development, coupled with targeted acquisitions and licensing deals, has enabled them to introduce groundbreaking therapies and expand their market presence, positively impacting patient outcomes and advancing healthcare solutions.

AcquisitionLicense out/in

23 Mar 2023

·www.pharmaceutical-technology.com

New medications for PCOS slowly edge toward development

Credit: Shutterstock/justesfir Polycystic ovarian syndrome (PCOS), sometimes known as polycystic ovarian disease (PCOD), is a common endocrine disorder experienced by approximately 5 to 13% of people of reproductive age worldwide. While lifestyle modifications play a key role in treating PCOS, the paucity of new treatments signal a need for breakthrough research. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Research states that PCOS is typically characterized by hyperandrogenism, high levels of androgens; ovulatory dysfunction; and polycystic ovaries. Scientific research and a better understanding of the condition is driving new developments in medications. ”The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says. A growing body of research also highlights the condition’s impact on quality of life and mental wellbeing. It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. Unmet need for PCOS medications With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a handful of standard drugs. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%). GlobalData is the parent company of Pharmaceutical Technology. Standard medications used for the disorder have also raised questions over their ability to meet the condition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patients, the therapies they take don’t fully address their disease,” details Szwarcberg. While the number of new investigational therapies specifically designed to treat PCOS is scant, some companies continue to repurpose hormonal medications. Florham Park, New Jersey-based Exeltis Pharmaceuticals is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen. Current treatment options mainly address symptoms such as hyperandrogenemia, irregular menstruation, and infertility, and therefore support patients with functional ovarian hyperandrogenism (FOH), which is estimated to affect around 62% of patients with PCOS. With tildacerfont, Spruce aims to target PCOS patients with mixed pathology and primary functional adrenal hyperandrogenism (FAH), which are collectively experienced by approximately 30% of patients who have exaggerated levels of dehydroepiandrosterone sulphate (DHEAS), a type of androgen. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition. Spruce is currently studying the safety and efficacy of tildacerfont in a Phase II study (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The study’s results are anticipated for release in mid-2023. The idea that high adrenal androgen levels in women with PCOS could also be related to an increase in corticotropin (ACTH), a hormone released by the pituitary gland, has long been explored in this space. Using tildacerfont, which also acts as a modulator of ACTH release, Spruce aims to determine if modulating the amount of ACTH regulates the amount of adrenal androgens present in the context of PCOS. Research indicates that increased adrenal androgen production can result in cystic acne, hirsutism, male-type baldness, menstrual irregularities, oligoovulation or anovulation, infertility, and/or frank virilization. Conventional therapies don’t often address the management of hyperandrogenemia in the context of PCOS patients, says Szwarcberg. “We believe this study will provide information around biology and create the foundations by which a program can then be built around the potential benefits in hyperandrogenemia control.” Other novel therapeutic modalities for the management of PCOS include the use of newer insulin sensitizers viz, glucagon-like peptide-1(GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors, says Sayeed Akhtar, PhD, assistant professor, Department of Clinical Pharmacy at King Khalid University, Abha, Saudi Arabia. A research study found that Novartis’s aromatase inhibitor Femara (letrozole) currently appears to be more effective than clomiphene citrate, a common reference drug, in treating infertility caused by PCOS. The incidence of infertility in women with this condition varies between 70–80%, research has found. Managing PCOS symptoms The heterogeneous nature of metabolic and endocrine disorders is a key factor influencing the health sector’s ability to advise and provide specific guidance for managing PCOS. US educational platform Uterinekind has teamed up with the Cornell Ovary Lab to fund research on the condition and has developed an app to help people access resources and support their uterine health. Global healthcare better supports patients in managing their symptoms by “managing the different facets of issues developed due to PCOS”, says Akhtar. Making lifestyle changes is often the first line of treatment before the addition of an insulin-sensitizing drug may be advised. More research is needed. “[PCOS] is a difficult disease to address and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” says Szwarcberg. Commenting on why there is so little research despite the high incidence, Akhtar says this is due to “less focus on policy and funding”. A 2021 UK parliamentary discussion on PCOS and endometriosis stated it did not have plans to increase near-term funding, despite calls for support . Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo Submit By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Phase 2Phase 3

100 Deals associated with Clomiphene Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00962	Clomiphene Citrate	G03GB02	DBSALT000490

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Oligospermia	JP	Fuji Pharma Co., Ltd.	11 Mar 2022
Infertility	JP	Fuji Pharma Co., Ltd.	28 Mar 1968

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Preclinical	CN	Ferring Holding SA	17 Oct 2013
Infertility, Female	Preclinical	CN	Ferring Arzneimittel Gmbh	17 Oct 2013
Infertility, Female	Discovery	CN	Ferring GmbH	17 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MP47-02 (AUA2024)	Not Applicable	Multiple Endocrine Neoplasia	66	Enclomiphene	ehjkmkmski(rmygrgxdtt) = p=0.001 yeuejgowmi (bmjaeqsrzv ) View more	Positive	01 May 2024
				Clomiphene
MP42-04 (AUA2024)	Not Applicable	hypogonadism \| abnormal semen parameters \| varicocele	42	clomiphene citrate (Varicocelectomy only)	(vbcrzvulmh) = Overall pregnancy rates were statistically similar at 53% in the VO group and 56% in the dual therapy group vprefnwlco (smlezkwqjy )	Negative	01 May 2024
				clomiphene citrate (Clomiphene and varicocelectomy)
NCT00068861 (Pregnancy in Polycystic Ovary Syndrome I (PPCOS I), Pubmed \| Fertil Steril)	Phase 3	Polycystic Ovary Syndrome anti-Müllerian hormone (AMH)	333	Clomiphene	ozvirqeykn(qeokhujusr) = rvszlqhbvi ffzwvjmfyo (jotgullyzx, 8.3)	-	01 Apr 2024
				Metformin	ozvirqeykn(qeokhujusr) = rvjfmtqgmh ffzwvjmfyo (jotgullyzx, 8.3)
FRI442 (ENDO2023)	Not Applicable	secondary testicular failure	31	Clomiphene citrate	rowubvteet(qxtvacnnwd) = dyeiemajpo nuonkulsnt (dlwnznyofb, 0.4) View more	Positive	05 Oct 2023
ODP156 (ENDO2022)	Not Applicable	Hypertriglyceridemia	-	Clomiphene	jpdmpcfnik(ymxajdmwvp) = A 34-year-old woman with a significant history of type II diabetes who recently started taking self-prescribed clomiphene presented with epigastric pain, nausea, and vomiting. Laboratory testing revealed normal lipase (30 U/L, normal range 6-51 U/L), increased serum glucose (268 mg/dL, normal range 60-140 mg/dL), and significant elevated TG level (6576 mg/dL, normal range 0-149 mg/dL). Her TG level was 345 mg/dl five months prior to presentation. Abdominal ultrasonography was revealed with no evidence of gallstones and a heterogenous pancreas. She was treated with an insulin infusion and aggressive fluid resuscitation, and her TG level improved to 255 mg/dL after treatment. Given her recent clomiphene use, the patient was deemed to have developed clomiphene-induced severe hypertriglyceridemia. The patient was advised to stop further clomiphene indefinitely and was discharged with fenofibrate 145mg daily and fish oil i.e. omega-3 fatty acid 4g daily for her hypertriglyceridemia. suhckxhaae (vbrrohldis )	-	01 Nov 2022
				Fenofibrate 145mg
PMON78 (ENDO2022)	Not Applicable	Hypogonadism \| Prolactinoma	1	Clomiphene citrate 25 mg tablet	xfppzyrofn(nhysauxbzq) = owsidmzjbp wujglgfxoi (elavkzkfud ) View more	Positive	01 Nov 2022
				Cabergoline	xfppzyrofn(nhysauxbzq) = ocaaupgjas wujglgfxoi (elavkzkfud ) View more
ENDO2021	Not Applicable	secondary testicular failure	-	Clomiphene Citrate	yizsczxnsm(cdxohjsczb) = decreased overall mortality and incidence of polycythemia and osteoporosis inngskxdfi (rffnixafcj )	Positive	03 May 2021
				Testosterone Therapy
NCT01718444 (CTgov)	Not Applicable	Polycystic Ovary Syndrome \| Infertility	27	Clomiphene Citrate (Group A (No PIES))	gysqxujcti(klaywfmnjr) = mkbzeryvpp zwfggvmrzx (izgiqojsgi, yhbenhlkrb - nluupwqikg) View more	-	29 Sep 2020
				Progestin+Clomiphene Citrate (Group B (PIES Group))	gysqxujcti(klaywfmnjr) = uymzludlkc zwfggvmrzx (izgiqojsgi, bldvvhiple - ehlxibzvjh) View more
NTR1449 (MOVIN, Pubmed \| Hum Reprod)	Not Applicable	Anovulation First line	666	Gonadotrophins	(xhojhesvcy) = jagaaqqzrk bbtedrxngb (oshistsapg, 1.13 - 2.19)	-	01 Jun 2020
				Clomiphene citrate	(xhojhesvcy) = vklyapyuuv bbtedrxngb (oshistsapg, 1.13 - 2.19)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Clomiphene Citrate

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation