Background:
Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents.
Objective:
To monitor the effects of HRT on adolescents with POI.
Eligibility:
Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed.
Design:
All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include:
Blood and urine tests.
A test of their heart function.
A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates.
A test of their grip strength. Participants will squeeze a handheld device as hard as they can.
Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner.
A test to measure skin pigmentation. Participants skin will be touched lightly with a device.
An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush.
Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.

Start Date28 May 2025

Sponsor / Collaborator-

CTRI/2024/05/068054

/ Not yet recruitingNot ApplicableIIT

To study the utility of Estrogen Receptor and Progesterone Receptor expression as an immunohistochemical predictive markers for tumour behaviour in comparison to histopathological parameters and Tumour, Lymph Node and Metastatic staging in colorectal carcinoma - Nil

Start Date10 Jun 2024

Sponsor / Collaborator-

IRCT20240207060932N1

/ SuspendedPhase 3IIT

Comparison of the effects of Persicaria hydropiper vaginal cream based on coconut oil and sesame oil with conjugated estrogen vaginal cream and placebo on vaginal atrophy and sexual function of postmenopausal women.

Start Date08 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Estrogens, Conjugated

100 Translational Medicine associated with Estrogens, Conjugated

100 Patents (Medical) associated with Estrogens, Conjugated

9,360

Literatures (Medical) associated with Estrogens, Conjugated

31 Dec 2025·JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Simvastatin-loaded liposomal nanoparticles as treatment for adenomyosis in a patient-derived xenograft mouse model: a pilot study

Article

Author: Kilic, Gokhan S. ; Saada, Jamal ; Ozpolat, Bulent ; Yang, Jinping ; Kirschen, Gregory W. ; Borahay, Mostafa A. ; Vincent, Kathleen L. ; Motamedi, Massoud ; Michel, Rachel

BACKGROUND:

Adenomyosis is a common gynaecological condition where ectopic endometrial glands and stroma grow within the myometrium. This condition has a high clinical burden impacting those afflicted with debilitating symptoms including heavy painful periods. Simvastatin is an oral hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, typically used to treat hyperlipidaemia. Simvastatin has recently shown promise for treating gynaecological conditions such as endometriosis and uterine fibroids with nanoliposomal formulations demonstrating improved efficacy. In this pilot study, we tested simvastatin-loaded liposomal nanoparticles on xenografted adenomyosis tissues in a patient-derived mouse model.

METHODS:

We surgically inserted oestrogen/progesterone pellets into mice, followed by adenomyosis tissue xenografts 15 days later. Mice were then randomised into three groups: control, simvastatin, and simvastatin-loaded liposomal nanoparticles (simvastatin-NP). We quantified the changes in adenomyosis xenograft size weekly using a calliper as well as ultrasound imaging 28 days after treatment, prior to sacrifice. We also measured the proliferation of biomarker Ki67 in the xenografted tissues using immunohistochemistry after animal sacrifice.

RESULTS:

Treatment with simvastatin-NP significantly reduced volume and weight of adenomyosis xenografts while attenuating Ki67 expression when compared to the control and simvastatin groups. Conclusions: This pilot study demonstrates promising improved efficacy of simvastatin delivered via liposomal nanoparticles. However, larger studies are needed to fully explore the potential of simvastatin-NP in adenomyosis.

01 Jul 2025·MATURITAS

Cardiovascular disease and female sexual health across the life span: a bidirectional link

Review

Author: Armeni, Eleni ; Armeni, Anastasia ; Chedraui, Peter ; Lambrinoudaki, Irene

Epidemiological research reveals that around 40 % of women aged 18-59 report significant concerns about their sexual experiences. Endothelial function and proper arterial blood flow through the hypogastric and pudendal arteries are critical in women for a normal vasculogenic response to sexual stimulation. Organic causes of female sexual dysfunction (FSD) often stem from neuropathy or vascular complications linked to cardiovascular risk factors. The relationship between cardiovascular disease (CVD) and FSD is multifactorial, influenced by various factors such as disease severity, physical and physiological factors, social determinants and factors related to medication use. Additionally, the pathophysiological mechanisms implicated in FSD of CVD patients include vascular, physical, psychological and hormonal factors. Hypertension, stroke, and myocardial infarction are closely interrelated with FSD, which is not the case for coronary heart disease, dyslipidemia, and peripheral obstructive artery disease. Hormonal treatment for sexual dysfunction in women with cardiovascular risk factors is discussed, concerning menopausal hormone therapy, tibolone, selective estrogen receptor modulators, vaginal estrogen, prasterone and testosterone therapy. On the other hand, the beneficial effect of sexual activity on cardiovascular health has been gaining supportive evidence. In healthy postmenopausal women aged 45-60, penile-vaginal intercourse has been suggested to positively influence cardiac autonomic functions, as indicated by heart rate variability. However, effectively addressing the challenges of aging and further highlighting the positive impact of sexual activity on cardiac health in selected female populations could significantly enhance life motivation and promote a healthy lifestyle during this stage. The present review elucidates the bidirectional relationship between CVD and female sexual function.

01 Jun 2025·Journal of Pediatric and Adolescent Gynecology

Length of Hospital Stay in Adolescents Receiving High-Dose Oral Contraceptive Pills with and without Conjugated Equine Estrogen for the Treatment of Acute Abnormal Uterine Bleeding

Article

Author: Durazo-Arvizu, Ramon ; Nelson, Anita ; Borzutzky, Claudia ; Jaffray, Julie ; Khalighi, Misha ; Belzer, Marvin

STUDY OBJECTIVE:

Compare the length of hospital stay (LOHS) of adolescents admitted for severe anemia (hemoglobin ≤8 g/dL) due to acute abnormal uterine bleeding (AUB) treated with high-dose combined oral contraceptive pills (HD-OCPs) vs those treated with HD-OCPs and intravenous conjugated equine estrogen, also referred to as dual therapy.

DESIGN, SETTING, AND PARTICIPANTS:

This is a single-institution retrospective cohort study of adolescents hospitalized for the management of acute AUB and severe anemia between July 1, 2004, to January 1, 2020. Subjects were excluded if they were pregnant, had a malignancy, thrombocytopenia, treated with other hormonal therapies, or if bleeding stopped prior to admission.

MAIN OUTCOME MEASURES:

Primary outcome was LOHS. Secondary outcomes were rates of complications and side effects secondary to the hormonal medication.

RESULTS:

There were 113 subjects included in the study. Seventy-four (65%) received HD-OCPs only, and the remainder received dual therapy. Mean subject age was 13.8 years for both groups. Those who received HD-OCPs alone were hospitalized for an average of 38.4 vs 45.6 hours for those who received dual therapy (P = .0007). The only reported side effect in either group was nausea and/or vomiting, which was higher in the group who received dual therapy than those treated with HD-OCPs alone (85% vs 51.4% respectively, P value = .001).

CONCLUSION:

Adolescents who received dual therapy had a longer hospital stay than those who received HD-OCPs alone. There were no complications related to the medication regimens in either group, but those receiving dual therapy had significantly higher rates of anti-emetic use.

News (Medical) associated with Estrogens, Conjugated

26 May 2025

·www.globenewswire.com

CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. If approved, the Itovebi-based regimen has the potential to transform the standard of care in this first-line setting, where treatments are currently limited.1 A final decision regarding the approval is expected from the European Commission in the near future. “The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is further enforced by the recent final overall survival results from the INAVO120 study, showing the regimen can meaningfully extend survival.” The presence of a PIK3CA mutation, found in approximately 40% of hormone receptor (HR)-positive breast cancers, can make the disease more aggressive and worsen survival outcomes.2,3 This underscores the importance of testing for PIK3CA mutations prior to first-line treatment so that people with a poor prognosis can benefit from an effective, PI3K-targeted therapy as soon as possible. The CHMP’s positive opinion is based on the phase III INAVO120 results, published in the New England Journal of Medicine in October 2024, which showed a 57% reduction in the risk of disease worsening or death (progression-free survival [PFS]) with the Itovebi-based regimen compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p1 The PFS benefit was consistent across all pre-specified subgroups, including people whose disease had spread to three or more locations, characterised as difficult-to-treat disease.1 The Itovebi-based regimen was well tolerated, with no new safety signals observed.1 Positive topline results from the final overall survival (OS) analysis, announced in January 2025, showed a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen. OS data were immature at the time of primary analysis, but a clear positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary of 0.0098)).1 The full results from the OS analysis will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. The Itovebi-based regimen is approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates and China, with data from INAVO120 under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with advanced PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1-3 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.8,9 The INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with a CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.10,11 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.11-13 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.10,11 Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96. [2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22:1002. [3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179. [4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499. [5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862. [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 April]. Available from: https://clinicaltrials.gov/study/NCT06790693. [8] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05. [9] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14. [10] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 April]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. [11] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696. [12] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20. [13] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCODrug Approval

14 Jan 2025

·pharma.economictimes.indiatimes.com

Long-acting contraceptives seem to be as safe as the pill when it comes to cancer risk: new study

New Delhi: Many women worry hormonal contraceptives have dangerous side-effects including increased cancer risk . But this perception is often out of proportion with the actual risks. So, what does the research actually say about cancer risk for contraceptive users? And is your cancer risk different if, instead of the pill, you use long-acting reversible contraceptives? These include intrauterine devices or IUDs (such as Mirena), implants under the skin (such as Implanon), and injections (such as Depo Provera). Our new study, conducted by the University of Queensland and QIMR Berghofer Medical Research Institute and published by the Journal of the National Cancer Institute, looked at this question. We found long-acting contraceptives seem to be as safe as the pill when it comes to cancer risk (which is good news) but not necessarily any safer than the pill. How does the contraceptive pill affect cancer risk? The International Agency for Research on Cancer, which compiles evidence on cancer causes, has concluded that oral contraceptives have mixed effects on cancer risk. Using the oral contraceptive pill: slightly increases your risk of breast and cervical cancer in the short term, but substantially reduces your risk of cancers of the uterus and ovaries in the longer term. Our earlier work showed the pill was responsible for preventing far more cancers overall than it contributed to. In previous research we estimated that in 2010, oral contraceptive pill use prevented over 1,300 cases of endometrial and ovarian cancers in Australian women. It also prevented almost 500 deaths from these cancers in 2013. This is a reduction of around 25% in the deaths that could have occurred that year if women hadn't taken the pill. In contrast, we calculated the pill may have contributed to around 15 deaths from breast cancer in 2013, which is less than 0.5% of all breast cancer deaths in that year. What about long-acting reversible contraceptives and cancer risk? Long-acting reversible contraceptives - which include intrauterine devices or IUDs, implants under the skin, and injections - release progesterone-like hormones. These are very effective contraceptives that can last from a few months (injections) up to seven years (intrauterine devices). Notably, they don't contain the hormone oestrogen, which may be responsible for some of the side-effects of the pill (including perhaps contributing to a higher risk of breast cancer). Use of these long-acting contraceptives has doubled over the past decade, while the use of the pill has declined. So it's important to know whether this change could affect cancer risk for Australian women. Our new study of more than 1 million Australian women investigated whether long-acting, reversible contraceptives affect risk of invasive cancers. We compared the results to the oral contraceptive pill. We used de-identified health records for Australian women aged 55 and under in 2002. Among this group, about 176,000 were diagnosed with cancer between 2004 and 2013 when the oldest women were aged 67. We compared hormonal contraceptive use among these women who got cancer to women without cancer. We found that long-term users of all types of hormonal contraception had around a 70% lower risk of developing endometrial cancer in the years after use. In other words, the risk of developing endometrial cancer is substantially lower among women who took hormonal contraception compared to those who didn't. For ovarian cancer, we saw a 50% reduced risk (compared to those who took no hormonal contraception) for women who were long-term users of the hormone-containing IUD. The risk reduction was not as marked for the implants or injections, however few long-term users of these products developed these cancers in our study. As the risk of endometrial and ovarian cancers increases with age, it will be important to look at cancer risk in these women as they get older. What about breast cancer risk? Our findings suggest that the risk of breast cancer for current users of long-acting contraceptives is similar to users of the pill. However, the contraceptive injection was only associated with an increase in breast cancer risk after five years of use and there was no longer a higher risk once women stopped using them. Our results suggested that the risk of breast cancer also reduces after stopping use of the contraceptive implants. We will need to follow-up the women for longer to determine whether this is also the case for the IUD. It is worth emphasising that the breast cancer risk associated with all hormonal contraceptives is very small. About 30 in every 100,000 women aged 20 to 39 years develop breast cancer each year, and any hormonal contraceptive use would only increase this to around 36 cases per 100,000. What about other cancers? Our study did not show any consistent relationships between contraceptive use and other cancers types. However, we only at looked at invasive cancers (meaning those that start at a primary site but have the potential to spread to other parts of the body). A recent French study found that prolonged use of the contraceptive injection increased the risk of meningioma (a type of benign brain tumour). However, meningiomas are rare, especially in young women. There are around two cases in every 100,000 in women aged 20-39, so the extra number of cases linked to contraceptive injection use was small. The French study found the hormonal IUD did not increase meningioma risk (and they did not investigate contraceptive implants). Benefits and side-effects There are benefits and side-effects for all medicines, including contraceptives, but it is important to know most very serious side-effects are rare. A conversation with your doctor about the balance of benefits and side-effects for you is always a good place to start.

Clinical Result

01 Dec 2024

·pharma.economictimes.indiatimes.com

Study links hormone therapy drugs to increased risk of heart conditions, blood clots

New Delhi, Drugs used in hormone therapy for postmenopausal women have been related with an increase in heart disease and blood clot risks, according to a study. Hormone replacement therapy helps relieve postmenopausal symptoms such as hot flushes and night sweats by replacing hormones that a woman's body is not producing enough. Researchers, including those from Uppsala University, Sweden, said that certain tablets containing both oestrogen and progestogen are associated with a higher risk of heart disease and rare, but serious blood clots , known as venous thromboembolism . However, tibolone -- another hormone therapy -- was associated with an increased risk of cardiovascular conditions, including heart attack and stroke, but not blood clots. These drugs are available in India. The findings, published in The British Medical Journal, highlighted "the diverse effects of different hormone combinations and administration methods on the risk of cardiovascular disease". The researchers said that while previous studies have suggested a link between hormone therapy and an increased risk of cardiovascular disease, information on specific risks linked to different types of therapy is unclear. For their analysis, the authors looked at 138 previously published studies, involving nearly 9.2 lakh women in Sweden aged 50-58 years between 2007 and 2020, and had not used hormone therapy in the previous two years. Tibolone and oestrogen-progestogen tablets were two of the eight types of hormone replacement therapies that the women were prescribed. National registry data were used to track cardiovascular events over two years, along with other aspects such as high blood pressure and diabetes. Over the follow-up period of two years, nearly 24,100 cardiovascular events were recorded among the 919,614 women studied. Taking tablets containing both oestrogen and progestogen or tibolone was associated with an increased risk of ischaemic heart disease, in which blood supply to heart is reduced because of a narrowing of vessels. This translates to about 11 new cases of ischaemic heart disease per a 1,000 women who start treatment with oral combined continuous therapy (taking oestrogen-progestogen tablets) or tibolone over one year, the researchers said. An increased risk of blood clots was also found for oral combined continuous therapy. "If 1,000 women started each of these treatments and were observed for a year, we would expect to see seven new cases of venous thromboembolism across all groups," the authors wrote.

100 Deals associated with Estrogens, Conjugated

External Link

KEGG	Wiki	ATC	Drug Bank
D04070	Estrogens, Conjugated	G03CA57	DB00286

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Oestrogen deficiency	Australia	Pfizer Australia Pty Ltd.	28 May 2012
Dyspareunia	United States	Wyeth Pharmaceuticals LLC	07 Nov 2008
Osteoporosis	United States	Wyeth Pharmaceuticals LLC	16 Jul 2003
Breast Cancer	United States	Wyeth Pharmaceuticals LLC	24 Apr 2003
Hypoestrogenism	United States	Wyeth Pharmaceuticals LLC	24 Apr 2003
Prostatic Cancer	United States	Wyeth Pharmaceuticals LLC	24 Apr 2003
Vasomotor symptom	United States	Wyeth Pharmaceuticals LLC	24 Apr 2003
Vulvovaginal atrophy	China	Wyeth Canada ULC	07 Mar 2001
Atrophic Vaginitis	United States	Wyeth Pharmaceuticals LLC	16 Oct 1978
Atrophy	United States	Ayerst-Wyeth Pharmaceuticals, Inc.	16 Oct 1978
Vulvar Lichen Sclerosus	United States	Wyeth Pharmaceuticals LLC	16 Oct 1978
Andropause	Japan	Pfizer Japan, Inc.	15 Apr 1964
Metrorrhagia	Japan	Pfizer Japan, Inc.	15 Apr 1964
Ovarian Diseases	Japan	Pfizer Japan, Inc.	15 Apr 1964
Vaginitis	Japan	Pfizer Japan, Inc.	15 Apr 1964
Endocrine System Diseases	United States	Wyeth Pharmaceuticals LLC	18 Dec 1956
Osteoporosis, Postmenopausal	United States	Wyeth Pharmaceuticals LLC	08 May 1942
Vascular Diseases	United States	Ayerst-Wyeth Pharmaceuticals, Inc.	07 May 1942

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Menopausal symptoms	Phase 3	United States	Teva Branded Pharmaceutical Products R&D, Inc.	01 Aug 2006
Parkinson Disease	Phase 2	United States	Wyeth AB	01 Oct 2003
Amenorrhea	Phase 2	-	Abbott Laboratories	01 Sep 2000
Primary Ovarian Insufficiency	Phase 1	Japan	Pfizer Inc.	01 Oct 2011
Hot Flashes	Phase 1	United States	Wyeth AB	01 Jun 2008
Pelvic Organ Prolapse	Clinical	United States	Pfizer Inc.	01 May 2012
Uterine Prolapse	Clinical	United States	Pfizer Inc.	01 May 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01648751 (CTgov)	Not Applicable	Pelvic Organ Prolapse \| Uterine Prolapse	21	Vaginal estrogen (Vaginal Estrogen)	vvruzhvzqb(hmepmtumkt) = dquuuwngok obkmkmwdqg (hfxoiwdgnn, ukpumnwqwn - whohveovao) View more	-	19 Sep 2024
				Placebo (Placebo Cream)	vvruzhvzqb(hmepmtumkt) = ondpptkchf obkmkmwdqg (hfxoiwdgnn, hoahzvghwg - cbovjpzcrp) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis	-	oestrogen (Premenopausal women)	znccxwphno(rybyegtwqv): HR = 2.8 (95% CI, 1.2 - 6.4)	-	05 Jun 2024
				oestrogen (Postmenopausal women)
NCT03943823 (CTgov)	Phase 4	Vaginal Discharge \| Bacterial Vaginosis	4	Premarin+Estrace (Estrogen Vaginal Cream)	ewswkcoomh(vaevksjpis) = esijzgjtdh hiifrzovhs (gzvwvyrast, 0.70) View more	-	01 Mar 2023
				Trimo-San vaginal gel (Trimo-San Vaginal Gel)	ewswkcoomh(vaevksjpis) = agadrbjstw hiifrzovhs (gzvwvyrast, 0) View more
NCT01958073 (VESPR, CTgov)	Phase 4	Urinary Tract Infections	35	Placebo (Placebo)	obucaqhbft = rnfupxjdyy yctgjnqwic (hmuyuefyld, enqglzmgul - varsnprxrl) View more	-	21 Sep 2020
				Conjugated Estrogen Vaginal Cream (Conjugated Estrogen Vaginal Cream)	lhozigziap = ockxeioxgs cayroytenu (pipnzskvhk, harooskzql - ilanyvnyse) View more
NCT00973102 (RESCUE-Shock \| RESCUE - Shock, CTgov)	Phase 2	Shock, Hemorrhagic \| Shock	50	Premarin IV (Premarin IV)	hdlipchsof = ltbpbnynpy ckylltlkld (xtfocdktnh, lpvfzisjwd - dvfzuevyiv) View more	-	19 Mar 2020
				Placebo (Placebo)	hdlipchsof = rihztphiqv ckylltlkld (xtfocdktnh, ggrphjuupw - ndcxkflfyq) View more
NCT00973674 (RESCUE-TBI, CTgov)	Phase 2	Brain Injuries, Traumatic	50	Premarin IV (Premarin IV)	miluqdftfl = bckvjjjwyt xrhektrsrl (dfhmmxctyz, tbfjoqlwul - mpmpwolvmn) View more	-	12 Nov 2019
				Placebo (Placebo)	miluqdftfl = vwjentmnzg xrhektrsrl (dfhmmxctyz, ardsnjsund - arqclfrbfa) View more
MON-160 (ENDO2019)	Not Applicable	Obesity leptin \| adiponectin \| FGF-21 ... View more	12	Conjugated Estrogens/Bazedoxifene	ytyufpjsoe(kjjonobaaq) = ucajhmzmdu jzffrtqgeq (chsouliedd, 3.1) View more	Positive	30 Apr 2019
				Placebo	ytyufpjsoe(kjjonobaaq) = afzqxbrhsw jzffrtqgeq (chsouliedd, 2.9) View more
NCT01268046 (CTgov)	Phase 1/2	Cognition \| Amnesia	38	Estradiol+transderman estrogen patch (Young Postmenopausal Women - Estrogen)	ewqbxuyzsf(hpwfchjlkf) = sabkcgtssf lckwutijro (xpjxgfvwnp, 164.3) View more	-	22 Aug 2018
				Estradiol oral capsule+transderman estrogen patch (Older Postmenopausal Women - Estrogen)	ewqbxuyzsf(hpwfchjlkf) = pxqyujdzti lckwutijro (xpjxgfvwnp, 90.1) View more
NCT00604825 (CTgov)	Phase 2	Menopausal symptoms \| Vasomotor symptom \| Hot Flashes ... View more	356	Other: Placebo	yzqkagscoy = uhbrmzectt esijillbox (izdypwtfpj, uoacbqtxhs - ktknvvvqdb) View more	-	03 Oct 2017
NCT00386022 (CTgov)	Phase 2/3	-	19	GnRH+Estrogen patch (Young Postmenopausal Women)	oiwhtdcgud(kitaomqipg) = frztqkvzpx vfruyrupkt (trpyluvhky, 1.9) View more	-	13 Apr 2017
				GnRH+Estrogen patch (Older Postmenopausal Women)	oiwhtdcgud(kitaomqipg) = aawiyeonkn vfruyrupkt (trpyluvhky, 1.0) View more

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Estrogens, Conjugated

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