Clinical trials: Pre-menopause
Uterine Fibroids
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
- Trial name
- NCT00882258
- Testing
- 12.5 mg Proellex, 25 mg Proellex
- Where
- 16 sites in United States
- Volunteers
- 144 people
- Sponsor
- Repros Therapeutics Inc.
Advanced Breast Cancer
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of…
- Trial name
- NCT00322348
- Testing
- Goserelin acetate
- Where
- 14 sites in Czechia, Russia and 1 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Infertility
MENOPUR® Versus FOLLISTIM®
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF)…
- Trial name
- NCT00802360
- Testing
- Menotropin, Progestrone vaginal insert, follitropin beta
- Where
- 7 sites in United States
- Volunteers
- 173 people
- Sponsor
- Ferring Pharmaceuticals
Breast Cancer
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer
The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.
- Trial name
- FRAME (NCT00878930)
- Where
- 16 sites in Argentina
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Vasomotor Symptoms (VMS) Associated With Menopause
An Observational Study to Learn More About Vasomotor Symptoms Burden and Treatment Patterns in Menopausal Women Before and After Participating in OASIS Studies
This is an observational study to learn more about vasomotor symptoms (VSM) burden and treatment patterns in menopausal women before and after participating in OASIS studies.
- Trial name
- OASIS STAR (NCT06949553)
- Testing
- No study intervention
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Contraception
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women.
- Trial name
- INDessa (NCT03562624)
- Testing
- BAY98-7443, Levonogestrel (Skyla, BAY86-5028)
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Subjects
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects.
- Trial name
- NCT03436849
- Testing
- ESN364
- Where
- Japan
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Iron-deficiency
Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but…
- Trial name
- NCT05950841
- Testing
- Low dose IHAT, High Dose IHAT, Carob flour
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- RDC Clinical Pty Ltd
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment.
- Trial name
- NCT00702702
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 30 sites in United States
- Volunteers
- 56 people
- Sponsor
- Repros Therapeutics Inc.
Focus of the Study is Insulin Sensitivity
Effects of Dietary Fiber on Insulin Sensitivity
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks.
- Trial name
- NCT01521806
- Testing
- Dietary Fiber
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ingredion Incorporated
Breast Neoplasm
Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.
- Trial name
- NCT00107016
- Testing
- RAD001, Letrozole 2.5mg, Letrozole 2.5mg
- Where
- 46 sites in United States, Austria and 8 more
- Volunteers
- 267 people
- Sponsor
- Novartis Pharmaceuticals
HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy
Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of these results to patients in the real-world setting is challenging, given RCTs are conducted in highly selected patient populations.
- Trial name
- Treat ER+ight (NCT02753686)
- Testing
- Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy
- Where
- 25 sites in Canada
- Volunteers
- 440 people
- Sponsor
- Novartis Pharmaceuticals
Contraception
Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch
A single-center, randomized, open-label, parallel-group, multi-arm, phase II clinical trial in healthy women aged 18 to 35 years who have a documented ovulatory cycle prior to randomization.
- Trial name
- NCT06048536
- Testing
- MR-130A-01 Transdermal patch
- Where
- Germany
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Breast Cancer
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage…
- Trial name
- EMBER-2 (NCT04647487)
- Testing
- LY3484356
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 87 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after…
- Trial name
- NCT01528345
- Testing
- Dovitinib, Fulvestrant
- Where
- 67 sites in United States, Argentina and 13 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
Endometriosis
A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219
This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1)…
- Trial name
- NCT03709420
- Testing
- FOR-6219
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Forendo Pharma Ltd
Breast Cancer
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced…
- Trial name
- NCT01073865
- Testing
- ZD9393 (Zoladex) 10.8 mg, ZD9393 (Zoladex) 3.6 mg
- Where
- 55 sites in India, Japan and 4 more
- Volunteers
- 222 people
- Sponsor
- AstraZeneca
Sexual Dysfunctions, Psychological
Flibanserin Randomized Withdrawal Trial in Pre-menopausal Women
To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.
- Trial name
- NCT00277914
- Testing
- Flibanserin
- Where
- 65 sites in United States, Canada
- Volunteers
- 749 people
- Sponsor
- Sprout Pharmaceuticals, Inc