Clinical trials: Premenopausal
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Sexual Dysfunctions, Psychological
24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.
- Trial name
- NCT00360529
- Testing
- flibanserin
- Where
- 54 sites in United States, Canada
- Volunteers
- 880 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Female Sexual Arousal Disorder
Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder
This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil…
- Trial name
- RESPOND (NCT04948151)
- Testing
- Sildenafil
- Where
- 51 sites in United States
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Strategic Science & Technologies, LLC
Menstrual Wellness
Radicle Menstrual Wellness™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
- Trial name
- NCT07138339
- Testing
- Menstrual Wellness Product 1
- Where
- United States
- Volunteers
- 850 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Healthy
Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel
Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.
- Trial name
- NCT01941615
- Testing
- faldaprevir, Microgynon®, BI 207127
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT05620355
- Testing
- BG2109, Add-back therapy
- Where
- 29 sites in China
- Volunteers
- 312 people
- Sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.
Breast Cancer
Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous…
- Trial name
- NCT00235937
- Testing
- Anastrozole and goserelin
- Where
- 7 sites in France
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
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
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast…
- Trial name
- NCT02154139
- Testing
- Leuprorelin acetate
- Volunteers
- 651 people
- Sponsor
- Takeda
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 1 (NCT03070899)
- Testing
- OBE2109, Add-back
- Where
- 116 sites in United States
- Volunteers
- 526 people
- Sponsor
- ObsEva SA
Breast Neoplasms
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer.
- Trial name
- preEMBER (NCT07287098)
- Testing
- Imlunestrant, Goserelin, Tamoxifen 20 mg
- Where
- 90 sites in United States, Belgium and 5 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
Breast Cancer, Ovarian Function
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy
Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by…
- Trial name
- PROOF (NCT00888082)
- Testing
- Goserelin acetate
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Sexual Dysfunctions, Psychological
Flibanserin Versus Placebo in Premenopausal Women With HSDD
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
- Trial name
- NCT00491829
- Testing
- 50 mg qhs, 100 mg
- Where
- 86 sites in Austria, Belgium and 11 more
- Volunteers
- 945 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Pharmacokinetics
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol.
- Trial name
- NCT02170038
- Testing
- Microgynon, Noristerat(BAY86-6308)
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Mammographic Density
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole
A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women
- Trial name
- NCT03314298
- Testing
- testosterone anastrozole
- Where
- Australia
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Havah Therapeutics Pty Ltd
Uterine Hemorrhage
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss.
- Trial name
- AQTH-EA-22 (NCT07580560)
- Testing
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 10 people
- Sponsor
- Aqua Therapeutics, Inc.
Iron Deficiency (Without Anemia)
Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting…
- Trial name
- NCT05257343
- Testing
- Liquid Iron Supplement (Blood Builder ®)
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Fertility
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single…
- Trial name
- NCT07269327
- Testing
- Desogestrel and ethinylestradiol fixed dose combination, Follitropin alfa/lutropin alfa
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Uterine Fibroids
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.
- Trial name
- NCT02811159
- Testing
- Telapristone acetate
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Repros Therapeutics Inc.