Clinical trials: Premenopausal
Uterine Fibroids, Heavy Menstrual Bleeding
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of…
- Trial name
- NCT02925494
- Testing
- Estradiol/Norethindrone Acetate, Elagolix
- Where
- 124 sites in United States, Canada and 1 more
- Volunteers
- 433 people
- Sponsor
- AbbVie
Premenopausal Breast Cancer
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
- Trial name
- NCT03209518
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 312 people
- Sponsor
- Takeda
Female Sexual Dysfunction
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
- Trial name
- NCT01364623
- Testing
- Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose, High dose testosterone nasal gel, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Acerus Pharmaceuticals Corporation
Uterine Fibroids
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
- Trial name
- NCT01451424
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit)…
- Trial name
- NCT02134977
- Testing
- Leuprorelin Acetate
- Volunteers
- 2,816 people
- Sponsor
- Takeda
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
Sexual Dysfunctions, Psychological
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
- Trial name
- NCT00996164
- Testing
- Flibanserin
- Where
- 75 sites in United States
- Volunteers
- 1,090 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Healthy
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood
The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral…
- Trial name
- NCT05613777
- Testing
- Microgynon®, Iclepertin
- Where
- Germany
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months).
- Trial name
- NCT00853567
- Testing
- Proellex
- Where
- 17 sites in United States
- Volunteers
- 71 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Endometriosis
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last…
- Trial name
- NCT01728454
- Testing
- Telapristone acetate
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for…
- Trial name
- NCT00605267
- Testing
- Tamoxifen, Anastrazole (Arimidex), Goserelin acetate (Zoladex)
- Where
- 4 sites in Japan
- Volunteers
- 197 people
- Sponsor
- AstraZeneca
Hypoactive Sexual Desire Disorder
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the…
- Trial name
- HSDD (NCT02333071)
- Testing
- Bremelanotide
- Where
- 91 sites in United States, Canada
- Volunteers
- 723 people
- Sponsor
- Palatin Technologies, Inc
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
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.
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
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
Sexual Dysfunctions, Psychological
Uptitration Trial of Flibanserin Versus Placebo 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
- NCT00360555
- Testing
- flibanserin, flibanserin 50mg, flibanserin 100mg
- Where
- 77 sites in United States, Canada
- Volunteers
- 1,584 people
- Sponsor
- Sprout Pharmaceuticals, Inc