Clinical trials: Premenopausal Women
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women…
- Trial name
- NCT01817530
- Testing
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate
- Volunteers
- 571 people
- Sponsor
- AbbVie
Lactating Mother
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC.
- Trial name
- NCT06867835
- Testing
- Vyleesi (Bremelanotide Injection)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cosette Pharmaceuticals, Inc.
Healthy
Oral Contraceptive DDI Study
A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.
- Trial name
- NCT02494609
- Testing
- sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
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
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
- 87 sites in United States, Belgium and 5 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
Systemic Lupus Erythematosus
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
- Trial name
- NCT00739050
- Testing
- simvastatin
- Volunteers
- 4 people
- Sponsor
- Organon and Co
Advanced Breast Cancer, Early Breast Cancer
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
- Trial name
- NCT07310420
- Testing
- ZOLADEX
- Where
- 26 sites in United States
- Volunteers
- 176 people
- Sponsor
- TerSera Therapeutics LLC
Growth and Development
To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
- Trial name
- NCT03155269
- Testing
- Fortified Beverage Powder, Non fortified beverage Powder
- Where
- India
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Endometriosis
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
- Trial name
- NCT00556075
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 17 sites in United States
- Volunteers
- 67 people
- Sponsor
- Repros Therapeutics Inc.
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).
- Trial name
- NCT01328184
- Testing
- levonorgestrel, Ethinylestradiol, Microgynon + BI 10773
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Gut Dysbiosis, Telogen Effluvium
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Telogen effluvium (TE) is a common cause of diffuse, non-scarring hair shedding in women. It is often triggered by physiological stress, nutritional deficiencies, illness or hormonal changes.
- Conditions
- Gut Dysbiosis, Telogen Effluvium, Hair Loss
- Trial name
- NCT07869199
- Testing
- Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Olistic Research Labs S.L.
Endometriosis
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health.
- Trial name
- ELARIS EM-COC (NCT04333576)
- Testing
- Elagolix, Combined Oral Contraceptive
- Where
- 179 sites in United States, Puerto Rico
- Volunteers
- 800 people
- Sponsor
- AbbVie
Heavy Menstrual Bleeding, Uterine Fibroids
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Endometriosis
A Study of HS-10518 in Healthy Female Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.
- Trial name
- NCT06118827
- Testing
- HS-10518
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Premenopausal Women, Overweight and Obese Women
A Pilot Study to Characterize the Bioavailability and Plasma Profile of Potato Polyphenols in Humans
Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period.
- Trial name
- PPT (NCT02167607)
- Testing
- Active Comparator
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and…
- Trial name
- NCT00333229
- Testing
- Zoledronic Acid
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Uterine Fibroids
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to…
- Trial name
- NCT02301897
- Testing
- Telapristone Acetate
- Where
- 16 sites in United States
- Volunteers
- 43 people
- Sponsor
- Repros Therapeutics Inc.
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