Clinical trials: Premenopausal
Premenopausal Breast Cancer
A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer
- Trial name
- NCT01546649
- Testing
- TAP-144-SR(6M), TAP-144-SR(3M)
- Where
- 15 sites in Japan
- Volunteers
- 167 people
- Sponsor
- Takeda
Contraception
Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive).
- Trial name
- NCT05264506
- Testing
- NOMAC-E2 COC
- Where
- 103 sites in United States
- Volunteers
- 3,055 people
- Sponsor
- Organon and Co
Early-stage Breast Cancer
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in…
- Trial name
- ROSE (NCT05377684)
- Where
- 22 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Ipsen
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.
Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined)
Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree.
- Trial name
- PURPLE (NCT01857596)
- Testing
- bupropion, Lorexys low-dose, Lorexys moderate-dose
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- S1 Biopharma, Inc.
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
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer.
- Trial name
- OVELIA (NCT04906395)
- Testing
- TOL2506, Tamoxifen, Letrozole Tablets
- Where
- 59 sites in United States, Argentina and 5 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Sexual Dysfunctions, Psychological
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
- Trial name
- NCT00601367
- Testing
- flibanserin flexible dose
- Where
- 68 sites in Austria, Belgium and 10 more
- Volunteers
- 480 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Seizures, Convulsions
A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with…
- Conditions
- Seizures, Convulsions, Epilepsy, Osteopenia
- Trial name
- NCT01030094
- Testing
- Topiramate, Carbamazepine, Valproic acid
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Sexual Arousal Disorder
Using Thermography to Assess the Affects of Sildenafil Cream, 3.6%
The goal of this clinical trial is to compare thermography images in normal healthy premenopausal women after the application of Sildenafil Cream, 3.6%, L-arginine cream, and placebo cream.
- Trial name
- NCT05765487
- Testing
- Sildenafil, Vehicle
- Where
- Canada
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Breast Cancer
Zoladex® 10.8 BC RWS
This is a multi-center, retrospective-prospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate E2 suppressive effect of Zoladex® 10.8 mg is…
- Trial name
- NCT05184257
- Where
- 16 sites in China
- Volunteers
- 1,176 people
- Sponsor
- AstraZeneca
Desmoid Tumor, Aggressive Fibromatosis
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
This study is being conducted to study how nirogacestat may affect the ovarian function of adult premenopausal women with progressing desmoid tumors/aggressive fibromatosis.
- Trial name
- NCT07176689
- Testing
- Nirogacestat
- Where
- 23 sites in Belgium, Germany and 4 more
- Volunteers
- 50 people
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
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
Endometriosis
Open-Label Extension Study to ZPE-202
This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles, each with a 16 week active dosing period.
- Trial name
- NCT01961908
- Testing
- Proellex
- Where
- 7 sites in United States
- Sponsor
- Repros Therapeutics Inc.
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
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
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®
- Trial name
- NCT02175394
- Testing
- Microgynon®, BI 1356
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
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
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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
- NCT00735553
- Testing
- Proellex
- Where
- 15 sites in United States
- Volunteers
- 77 people
- Sponsor
- Repros Therapeutics Inc.