Clinical trials: Premenopausal
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
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
Uterine Fibroids
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
- Trial name
- NCT00737282
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 25 sites in United States
- Volunteers
- 175 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
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.
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
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
Breast Cancer
Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.
- Trial name
- SOFT-EST (NCT00975676)
- Testing
- gas chromatography / tandem mass spectometry
- Where
- 24 sites in France, Hungary and 6 more
- Volunteers
- 123 people
- Sponsor
- ETOP IBCSG Partners Foundation
Hot Flashes
Understanding Experimentally Induced Hot Flushes
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a…
- Trial name
- NCT00455689
- Testing
- Leuprolide acetate
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Healthy
This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other
The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on…
- Trial name
- NCT03193307
- Testing
- Microgynon® 30, BI 409306
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal…
- Trial name
- NCT01382719
- Testing
- bremelanotide
- Where
- 68 sites in United States, Canada
- Volunteers
- 612 people
- Sponsor
- Palatin Technologies, Inc
Breast Cancer
Study of Vitamin D for Premenopausal Women at High Risk for Breast Cancer
This proposal is for a pilot study of 20 premenopausal women at high risk for breast cancer development who will receive high dose vitamin D3, cholecalciferol 20,000 IU (2 capsules) weekly, or 30,000 IU (3 capsules) weekly, for 1…
- Trial name
- NCT00976339
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Katherine D. Crew
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
Breast Cancer, Breast Cancer, Early-Onset
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary…
- Trial name
- EMPRESS (NCT05659563)
- Testing
- Giredestrant, Tamoxifen
- Where
- 18 sites in France, Spain
- Volunteers
- 92 people
- Sponsor
- MedSIR
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
Breast Cancer
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal…
- Trial name
- NCT00295646
- Testing
- tamoxifen, anastrozole, zoledronic acid
- Where
- 72 sites in Austria, Germany
- Volunteers
- 1,803 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Type 1 Diabetes Mellitus
Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes
This overall research goal will be to develop a mobile-based module to improve glycemic control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM).
- Trial name
- NCT01653210
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Virginia