Comparison of the effect of the combination of letrozole and clomiphene in stimulating ovulation in intrauterine insemination cycles with letrozole alone: ??A clinical trial study

Start Date21 Apr 2026

Sponsor / Collaborator

Shahid Beheshti University of Medical Sciences

NCT07568574

/ Enrolling by invitationNot Applicable

Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting

Objectives:
The primary objective is to assess the safety and tolerability of medical drugs with the potential to enhance performance (PES) in professional athletes over a 5.5 year period, encompassing a 25-week PES Exposure period and 5 year long term follow-up of period comprehensive health and safety monitoring. The secondary objective is to evaluate the impact of PES on athletic performance through validated sport specific and clinical assessments.
Methods:
This prospective hybrid design study will enrol 60 adult participants, divided into two groups. The first group will receive performance-enhancing substances (PES) directly through the study, administered as Investigational Medicinal Products (IMPs) under comprehensive medical supervision for up to 25 weeks. The second group will include natural athletes and those already using PES prescribed by their own doctors. All substances used in this study are medically approved by national regulatory agencies (e.g., FDA, MHRA, EMA, EDE, etc.), and market authorised.
Participants undergo enrollment and baseline health and performance assessments, prior to a 25 weeks of PES exposure. During the period of PES exposure, participants undergo periodic monitoring of comprehensive physiological biomarkers alongside subjective assessments. Following the PES exposure phase, participants will complete repeat baseline health and performance assessments, followed by a titration phase and, where indicated, post-cycle therapy (PCT) to support the restoration of physiological function toward baseline. The study will conclude with a five-year longitudinal follow-up period to monitor long-term health outcomes. During this phase, participants will undergo annual assessments, including cardiac electrocardiography (ECG), echocardiography, magnetic resonance imaging (MRI), blood and urine biomarkers, routine vital signs, and quality-of-life measures. Additional imaging will include brain functional MRI (fMRI) and vital organ ultrasound at years 1, 3, and 5, with cardiac CT performed as clinically indicated. Athlete safety biomarker assessments, clinical evaluations, and adverse event reporting, will be continuously evaluated by study doctors and with additional safety oversight from a Data Safety Monitoring Board, Independent Medical Commission (a multidisciplinary panel of medical experts), and a Medical Monitor.

Start Date12 Mar 2026

Sponsor / Collaborator-

100 Clinical Results associated with Clomiphene Citrate

100 Translational Medicine associated with Clomiphene Citrate

100 Patents (Medical) associated with Clomiphene Citrate

5,836

Literatures (Medical) associated with Clomiphene Citrate

31 Dec 2026·GYNECOLOGICAL ENDOCRINOLOGY

Clomiphene citrate in the management of anovulation: a review of mechanisms, outcomes, and clinical challenges

Review

Author: Tadesse, Telila Mesfin

OBJECTIVE:

To review the mechanism of action, epidemiology, clinical efficacy, factors influencing treatment outcomes, and limitations of clomiphene citrate (CC).

METHODS:

A systematic literature search was conducted using electronic databases. The search strategy employed a combination of relevant MeSH terms and keywords. The final selection was limited to complete, peer-reviewed articles.

RESULTS:

Clomiphene citrate (CC) is the first-line oral ovulation induction agent for WHO Group II anovulation, most commonly polycystic ovary syndrome. It acts primarily at the hypothalamus, depleting estrogen receptors to increase gonadotropin-releasing hormone pulsatility and stimulate gonadotropin release. Although effective in restoring ovulation in approximately 73% of treated women, pregnancy rates remain significantly lower (~36%), highlighting a pronounced ovulation‒pregnancy gap. This discrepancy is largely attributed to CC's peripheral anti-estrogenic effects, which can cause endometrial suppression and hostile cervical mucus, thereby impairing implantation. Treatment success is influenced by factors such as obesity, insulin resistance, and hyperandrogenism, which are key predictors of CC resistance. While generally well-tolerated, side effects include hot flashes, mood swings, headaches, visual disturbances, and a notable risk of multiple pregnancies (8%-10%).

CONCLUSIONS:

While CC remains a cornerstone for inducing ovulation, its peripheral anti-estrogenic effects and significant rate of resistance necessitate adjunctive strategies, careful patient selection, and a transition to advanced therapies when needed to improve live birth outcomes.

01 Oct 2026·Cancer Epidemiology

Identifying carcinogenic hazards among pharmaceutical agents: An update from the IARC Monographs programme

Review

Author: Pasqual, Elisa ; Rezende da Silva, Julia ; de Conti, Aline ; Madia, Federica ; Schubauer-Berigan, Mary K ; Kunzmann, Andrew ; Facchin, Caterina

BACKGROUND:

We aim to review the evaluation of pharmaceuticals classified as human carcinogens by the International Agency for Research on Cancer (IARC) Monographs programme (1971-2024) and the recommended evaluation priorities (2024-2029) for pharmaceuticals. This work aims to stimulate epidemiological research that can contribute to human cancer and mechanistic evidence for cancer hazard identification.

METHODS:

Data on cancer in humans or experimental animals, and mechanistic evidence, for pharmaceuticals evaluated as IARC Group 1, 2 A, and 2B (carcinogenic, probably carcinogenic, and possibly carcinogenic to humans, respectively) between 1971 and 2026 were extracted from published IARC monographs. Pharmaceuticals given high priority for evaluation by the IARC Monographs Advisory Group for the period 2025-2029 were summarised, highlighting available data in human cancer or mechanistic studies.

RESULTS:

77 pharmaceuticals have been evaluated as Group 1 (n = 24), 2 A (n = 13), or 2B (n = 40). 22 pharmaceuticals were recommended with high priority for evaluation, including 8 antineoplastic, 4 hormonal, and 2 immunosuppressant agents. The IARC Advisory Group gave high priority for evaluation to several commonly used pharmaceuticals, including several treatments in cancer patients (anthracyclines, cisplatin, textured implants), highlighting evidence of increased haematological and solid malignancies; GLP-1 agonists; paracetamol; progestogen-only contraceptives; and clomiphene citrate. Evidence from studies conducted in humans with cancer or mechanistic endpoints largely contributed to this prioritisation.

DISCUSSION:

Pharmacoepidemiology data with cancer or mechanistic endpoints can largely contribute to cancer hazard identification of pharmaceuticals within the IARC Monographs programme. These data can inform policy decision-making for patients and workers protection.

01 Aug 2026·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Clomiphene citrate versus testosterone replacement therapy in male hypogonadism: a systematic review of literature and meta-analysis

Review

Author: Shiomi da Cruz, Jose Arnaldo ; Mendes, Caio M O ; Fraietta, Renato ; Schiavon, Beatriz N ; Galligani, Lilian ; Maia, Ronaldo Soares ; Constantinou, Beatriz T ; da Sardenberg, Rodrigo Afonso Silva ; Uzueli, Beatriz ; Petri, Maria Micaela G ; Benedicto, Bianca C

Abstract:

Introduction:

Male hypogonadism, including age-related and functional forms, is characterized by insufficient testosterone production often associated with obesity and metabolic comorbidities. Testosterone replacement therapy (TRT) increases serum testosterone but suppresses spermatogenesis and may cause adverse effects. Selective estrogen receptor modulators (SERMs), such as clomiphene citrate, have emerged as an alternative approach to restore endogenous testosterone while preserving fertility. This study aimed to compare the efficacy of clomiphene citrate versus testosterone replacement therapy (TRT) in increasing serum testosterone levels in men with hypogonadism.

Methods:

We conducted a systematic review of the literature in PubMed, Embase, Scopus, The Cochrane Library, and Google Scholar to identify studies comparing clomiphene citrate and testosterone replacement therapy (TRT) in men with male hypogonadism’. The primary outcome was the change in serum testosterone levels before and after treatment. Secondary outcomes included variations in other hormonal parameters, and clinical symptom improvement assessed through standardized instruments.

Results:

A total of 11 studies with 1512 patients were included (764 on clomiphene citrate; 748 on testosterone replacement therapy, TRT). For serum testosterone, the overall pooled effect showed no significant difference between clomiphene and TRT (MD = 6.64 ng/dL; 95% CI -35.35 to 48.63; I² = 80.6%). Subgroup analyses indicated injectable testosterone achieved higher levels than clomiphene (1 study, 62 patients; MD = -290.50; 95% CI -518.78 to -62.22), whereas gel-based TRT showed no difference (8 studies, 1012 patients; MD = 24.29; 95% CI -18.91 to 67.48; I² = 76.1%). For sexual function, three studies (199 patients; 85 on clomiphene; 114 on TRT) assessing post-treatment libido (ADAM 1–5) showed lower libido scores with clomiphene than TRT (MD = − 0.54; 95% CI − 0.87 to − 0.21; P = 0.009; I² = 18.8%).

Conclusions:

No statistically significant difference in serum testosterone levels was observed between clomiphene citrate and testosterone gel, although the evidence is limited by high heterogeneity and some concerns to high risk of bias. TRT was associated with greater improvements in libido. These findings should be interpreted as preliminary, and large-scale randomized trials incorporating clinical and fertility endpoints are needed.

News (Medical) associated with Clomiphene Citrate

23 Jul 2026

·www.fiercepharma.com

FDA rebukes 2 Indian API plants over data controls, sanitation issues

The FDA has chastised a pair of India-based API manufacturers in separate warning letters, outlining poor record-keeping, problems maintaining sanitation problems and licensing issues, among other observations. The U.S. regulatory agency inspected Almon Healthcare’s Ahmedabad, India, facility in February and said it found “significant deviations” that have resulted in the latest reprimand. During the inspection, the agency noted the company failed to do identity testing on raw materials used to produce active pharmaceutical ingredients (API) that were ultimately bound for use in pharmacy compounding. The company "intentionally accepted lots of" a redacted material "that were deliberately mislabeled by your supplier,” the FDA said in its letter to Almon, dated July 13. “Your [quality unit] admitted that this was a deliberate and ongoing practice since 2024 to circumvent your firm’s lack of a required license.” The mislabeled and untested material was used to produce batches that were then shipped to the U.S., the agency added. Almon was also slammed in the letter for lackluster efforts to confirm that all of its testing procedures were scientifically sound and appropriate to ensure its intermediates and API conform to regulatory standards. The FDA also found that the company didn’t adequately clean non-dedicated API production equipment used to manufacture an undisclosed number of different APIs. An inspector saw contaminants on product contact surfaces and an unspecified liquid draining from a container, although the equipment had been documented as “empty and cleaned.” In the case of Shimoga Chemicals and its facility in the Indian state of Maharashtra, the FDA issued a warning letter, also dated July 13, covering an inspection held at the site between January 19-23. That review resulted in three observations that included failure to implement adequate controls over the site's analytical testing data, subpar process validation and lack of assurance that the company's drug ingredients are being produced in accordance with Current Good Manufacturing Practices. The facility churns out clomiphene citrate (Clomid), also intended for U.S. pharmacy compounding to treat female infertility in patients who do not ovulate regularly or at all. Inspectors found the company lacked proper sampling procedures and records, and Shimoga didn’t perform verification studies for any test methods around the product, either, per the FDA's write-up. “Your firm failed to verify the residual solvent method used by your contract testing laboratory,” the FDA said. “During the inspection, your QC manager confirmed that no method verification has been performed for any of the test methods used for clomiphene citrate USP.” The company was also rebuked for sloppy cleaning procedures related to non-dedicated equipment used during the production of clomiphene citrate.

05 Jun 2026

·www.einpresswire.com

My TRT App releases free public bloodwork analyzer and peptide reference library

Indie iOS and Android application adds AI-assisted laboratory PDF extraction as U.S. testosterone prescriptions exceed 11 million annually. My doctor told me my testosterone was 'in range' more than once before I learned the standard range is built for the average 80-year-old. MyTRTApp exists because biohackers deserve a real tool.” — Himanshu Batra, Founder of Sphnix, Inc. WASHINGTON, DC, UNITED STATES, June 5, 2026 / EINPresswire.com / -- My TRT App, an iOS and Android application developed by Sphnix, Inc., has released a public bloodwork analyzer and an 89-compound peptide and GLP-1 reference library. Both tools are available at mytrt.app and do not require account creation. The release follows several years of growth in the testosterone replacement therapy (TRT) and GLP-1 weight-loss markets. U.S. testosterone prescriptions grew from approximately 7.3 million in 2019 to more than 11 million in 2024, according to industry pharmacy data. In April 2026, the U.S. Food and Drug Administration published guidance noting that testosterone therapy may be appropriate for treating low libido in patients with idiopathic hypogonadism, expanding the population for whom the therapy is being considered. GLP-1 medications including semaglutide and tirzepatide have also moved into mainstream prescribing, often alongside hormone therapy. A subset of patients on these therapies — sometimes described as self-directed or as biohackers — track their own laboratory results, monitor biomarkers between scheduled clinical visits, and adjust protocols in consultation with their prescribers. LABORATORY PDF EXTRACTION The My TRT App bloodwork analyzer ( TRT bloodwork analyzer ) extracts more than 40 biomarkers from uploaded laboratory PDF files. Extracted markers include total testosterone, free testosterone, sex hormone-binding globulin (SHBG), estradiol, dihydrotestosterone (DHT), hematocrit, hemoglobin, prostate-specific antigen (PSA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH), and standard lipid, metabolic, liver, and kidney panels. The tool uses Google Gemini Vision for optical character recognition. Free users receive one lifetime extraction; additional extractions are available to subscribers. A separate web tool, the Lab Snapshot Analyzer at mytrt.app/learn/tools/lab-snapshot, provides interpretation of six headline TRT markers in a browser without account creation. PEPTIDE AND GLP-1 LIBRARY The My TRT App GLP-1 and peptide library catalogs 89 compounds tracked by self-directed users, including semaglutide, tirzepatide, retatrutide, BPC-157, TB-500, human chorionic gonadotropin (hCG), anastrozole, clomiphene, MK-677, RAD-140, NAD+, GHK-Cu, MOTS-c, and melanotan. Each entry includes mechanism of action, reported half-life, documented effects, side-effect profile, and references to external research. The library is available on the public web at mytrt.app/learn/peptides and within the application. The My TRT App web reference also publishes 56 biomarker pages with clinical context, four laboratory and dosing calculators including a Vermeulen-equation free testosterone calculator, and seven long-form articles on hormone therapy topics. APPLE WATCH COMPANION The application includes a watchOS companion with one-tap dose logging and six complications, including a hematocrit complication that surfaces the most recent reading on the watch face. Elevated hematocrit (polycythemia) is among the more commonly monitored side effects of testosterone therapy. FOUNDER COMMENT "The category we set out to build for is patients who already do this work — who keep notes between draws and who chart their own trends," said Himanshu Batra, founder of Sphnix, Inc. and developer of My TRT App. "We wanted to provide a tool that matches that level of attention without putting the underlying data behind a clinic subscription." AVAILABILITY My TRT App is available on the Apple App Store and Google Play. A free tier includes dose logging, calendar tracking, and Apple Watch functionality. A subscription tier is available for users who require unlimited laboratory extraction and additional features. * iOS: https://apps.apple.com/app/my-trt-app/id6745529127 * Android: https://play.google.com/store/apps/details?id=com.batra.mytrtapp * Lab Snapshot Analyzer: https://www.mytrt.app/learn/tools/lab-snapshot * Peptide reference: https://www.mytrt.app/learn/peptides ABOUT MY TRT APP My TRT App is a TRT tracking app for iOS, Android, and watchOS, developed by Sphnix, Inc. The application was first released in 2025 and serves users tracking testosterone replacement therapy, hormone replacement therapy, peptide protocols, and GLP-1 medications. Himanshu Batra Sphnix, Inc +1 571-217-0000 hello@mytrt.app Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

18 Mar 2026

·www.drugs.com

Overall Cancer Incidence Not Higher With Medically Assisted Reproduction

WEDNESDAY, March 18, 2026 -- Among women using medically assisted reproduction (MAR), the overall incidence of cancer was comparable to that of the general population, according to a study published online March 10 in JAMA Network Open . Claire Melissa Vajdic, Ph.D., from University of New South Wales in Sydney, and colleagues compared cancer incidence in MAR-exposed women versus the general population of women. The analysis included 417,984 women (aged 18 to 55 years) who used MAR from 1991 to 2018 (assisted reproductive therapy [ART], 65.7 percent; intrauterine insemination with ovarian stimulation [IUI/OS], 28.9 percent; and ovulation induction using clomiphene citrate [clomiphene citrate], 42.0 percent). The researchers found that the overall incidence of invasive cancer was comparable with that of the general population for the ART and IUI/OS groups. Risk trended toward elevation for the clomiphene citrate cohort. Across all MAR exposures, the incidence rates of uterine cancer and in situ and invasive melanoma were higher, while lower incidence rates were seen for cervical cancer and cancer of the trachea, bronchus, and lung. For the ART and IUI/OS groups, ovarian cancer incidence was higher. Only the ART cohort had higher in situ breast cancer incidence, but the incidence of invasive breast cancer was not elevated. For invasive cancers with elevated incidence, rate differences were all small (<1 to 6.51 cases per 100,000 person-years). "Women who've had assisted fertility should continue to participate in routine cancer screening programs they’re eligible for," co-lead author Adrian Raymond Walker, Ph.D., also from University of New South Wales, said in a statement. "And they should discuss their cancer risk with their doctor, to understand how else they can reduce their risk." Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text

Clinical Result

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	Japan	Fuji Pharma Co., Ltd.	11 Mar 2022
Infertility	United States	Sanofi-Aventis U.S. LLC	01 Feb 1967

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	China	Ferring GmbH	17 Oct 2013
Infertility, Female	Phase 3	China	Ferring Holding SA	17 Oct 2013
Infertility, Female	Phase 3	China	Ferring Arzneimittel Gmbh	17 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05206448 (CLC II, CTgov)	Phase 4	Polyendocrine Metabolic Ovarian Syndrome \| Infertility \| Anovulation	190	letrozole (Letrozole)	rkklqrfgqc = wzgvbiecyu wgiahvwkvc (tgloiuxwfc, hbkepqzgil - rwgwghxoxp) View more	-	15 Apr 2025
				letrozole+Clomiphene citrate (Letrozole + Clomiphene Citrate)	rkklqrfgqc = hzscdfoybv wgiahvwkvc (tgloiuxwfc, usbmhrmrlt - aadckyvtqt) View more
ChiCTR2000029882 (Pubmed \| Front Endocrinol (Lausanne))	Not Applicable	Polyendocrine Metabolic Ovarian Syndrome	86	Acupuncture combined with clomiphene	syyxijwsul(njqjhncrtf) = pkiofgmjxr bfhtjejzrn (uatrhgufvc, -1.14 to -0.46)	Positive	19 Dec 2024
				Clomiphene	syyxijwsul(njqjhncrtf) = etclhkxwio bfhtjejzrn (uatrhgufvc, -0.47 to 0.01)
NCT00068861 (Pregnancy in Polycystic Ovary Syndrome I (PPCOS I), Pubmed \| Fertil Steril)	Phase 3	Polyendocrine Metabolic Ovarian Syndrome anti-Müllerian hormone (AMH)	333	Clomiphene	omycawocwz(ulsdamriui) = xzmbpgodcp lptpwjqzxt (ioqkcmyjvo, 8.3)	-	01 Apr 2024
				Metformin	omycawocwz(ulsdamriui) = wyboguokbg lptpwjqzxt (ioqkcmyjvo, 8.3)
NTR1449 (M-ovin trial, Pubmed \| Hum Reprod)	Not Applicable	-	666	Gonadotrophins	jvvwfwlams(bywcbvlune) = snhpimdhqa cpsumsyqop (ywxkmoqtac ) View more	-	01 Mar 2023
				Clomiphene citrate (CC)	jvvwfwlams(bywcbvlune) = eiubynftzv cpsumsyqop (ywxkmoqtac ) View more
NCT01718444 (CTgov)	Not Applicable	Polyendocrine Metabolic Ovarian Syndrome \| Infertility	27	Clomiphene citrate (Group A (No PIES))	fnlqrujxii(rotnnyxzcr) = ukqnvxyzcu sdqpeohjnt (oepjfdtdgk, ussrmcereh - dndtbwsjuv) View more	-	29 Sep 2020
				Progestin+Clomiphene citrate (Group B (PIES Group))	fnlqrujxii(rotnnyxzcr) = dslchjcuts sdqpeohjnt (oepjfdtdgk, ysqogsdgdc - ywsirjkzkl) View more
NTR1449 (MOVIN, Pubmed \| Hum Reprod)	Not Applicable	Anovulation First line	666	Gonadotrophins	tuzevnsyyr(zpksexmamw) = iuyzctcrlz hvlizdjvvd (mdpecnsosj, 1.13 - 2.19)	-	01 Jun 2020
				Clomiphene citrate	tuzevnsyyr(zpksexmamw) = bbhvarcnmy hvlizdjvvd (mdpecnsosj, 1.13 - 2.19)
NCT02710981 (CTgov)	Not Applicable	Infertility \| Anovulation	42	Clomiphene Citrate (Clomiphene Citrate Only Group (6th Ovulation Induction Cycle))	vgddssdady(tirhzjyobj) = khhfgsceyl exdmywxkbo (gdupuapttg, 1.4) View more	-	05 May 2020
				Sildenafil+Clomiphene Citrate (Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation))	vgddssdady(tirhzjyobj) = kdpopmtuul exdmywxkbo (gdupuapttg, 3.1) View more
NCT03933618 (CAP, CTgov)	Phase 2	Eunuchism	24	Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-clomiphene-placebo)	xvmicuuvdy = yfyzefojfs xlqxhvemwp (vyimypbeng, repldsljcy - aaqngypues) View more	-	18 Nov 2019
				Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-placebo-clomiphene)	xvmicuuvdy = juenttjpzh xlqxhvemwp (vyimypbeng, mqymizbwsd - taubrycfzu) View more
NCT02802865 (CTgov)	Phase 4	Polyendocrine Metabolic Ovarian Syndrome \| Infertility	70	Letrozole (Letrozole)	vdsgwlvmxe = zpgiwfttjq qrjeckyeok (npkiuueypj, ypicgxyajv - cerdxobeet) View more	-	27 Sep 2019
				Clomiphene+Letrozole (Letrozole + Clomiphene)	vdsgwlvmxe = edwihdvwfe qrjeckyeok (npkiuueypj, iczntvkxjp - oekiudgqyx) View more
NCT02274311 (CTgov)	Phase 2	Acromegaly	16	Clomiphene citrate	lnmwsfuvzg(seobgxrimq) = itkpksfqgy gffuiynvzq (gugfosslrq, 108) View more	-	07 May 2019

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