Clinical trials: Pre-menopause
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.
Ovarian Cancer
Optimal Timing of BR55 CEUS of the Ovaries
This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal…
- Trial name
- NCT04248153
- Testing
- BR55
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Bracco Diagnostics, Inc
Sexual Dysfunction, Physiological
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit.
- Trial name
- FSAD HWO VBF (NCT00443248)
- Testing
- Vaginal Heat Wash-Out Device
- Where
- 2 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Sexual Dysfunctions, Psychological
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
- Trial name
- NCT00441558
- Testing
- Flibanserin
- Where
- 196 sites in United States, Canada
- Volunteers
- 1,723 people
- Sponsor
- Sprout Pharmaceuticals, Inc
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
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
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
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
Pre-menopausal Breast Cancer, PI3K Pathway Inhibition
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy…
- Trial name
- B-YOND (NCT02058381)
- Testing
- alpelisib (BYL719), buparlisib (BKM120)
- Where
- 15 sites in Hong Kong, South Korea and 2 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.
This study will recruit 168 patients in approximately 20 study centres in China. The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression…
- Trial name
- LARES (NCT03658213)
- Testing
- ZOLADEX 10.8 mg, ZOLADEX 3.6mg
- Where
- 11 sites in China
- Sponsor
- AstraZeneca
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
Recurrent Urinary Tract Infection
The Effect of Increased Water Intake on the Frequency of the Clinical Recurrent Urinary Tract Infections in Pre-menopausal Women: S-HYDRACYST
The purpose of this study is to determine whether increased water intake is effective in preventing episodes of uncomplicated urinary tract infections (UTI) in pre-menopausal women suffering from UTI recurrences.
- Trial name
- S-HYDRACYST (NCT02444975)
- Testing
- Mineral water, Coaching program, No intervention
- Where
- Bulgaria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Endometriosis
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe…
- Trial name
- ELENA (NCT05560646)
- Testing
- OG-6219
- Where
- 86 sites in United States, Belgium and 9 more
- Volunteers
- 354 people
- Sponsor
- Organon and Co
Mammographic Density
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.
- Trial name
- NCT03264651
- Testing
- enobosarm
- Where
- Australia
- Volunteers
- 9 people
- Sponsor
- Havah Therapeutics Pty Ltd
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
- Trial name
- NCT00785356
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 7 sites in Mexico
- Volunteers
- 8 people
- Sponsor
- Repros Therapeutics Inc.
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
Contraception
To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the…
- Trial name
- NCT02490774
- Testing
- BAY1007626, Jaydess, Mirena
- Where
- 7 sites in Germany, Netherlands and 1 more
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Bayer
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
BN83495 Phase I in Post-menopausal Women
The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease…
- Trial name
- NCT01840488
- Testing
- Irosustat (BN83495)
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 50 people
- Sponsor
- Ipsen