Clinical trials: Premenopausal Women
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant…
- Trial name
- NCT06893796
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Uterine Fibroids
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
- Trial name
- NCT01739621
- Testing
- Proellex 12 mg, Proellex 24 mg
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Fertility
Fertility in Healthy Premenopausal Women
The study objectives are described below: 1. Obtain serum specimens collected for one ovulatory cycle or a maximum of 33 days, but not to exceed a total of 550 ml of whole blood per subject from a minimum of 60 healthy…
- Trial name
- NCT02772848
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fujirebio Diagnostics, Inc.
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.
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.
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
Healthy Adult Premenopausal Female Volunteers
Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects
A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15…
- Trial name
- NCT02641990
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Intarcia Therapeutics
Uterine Fibroids, Endometriosis
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in…
- Trial name
- NCT05862272
- Testing
- Relugolix Combination Tablet
- Where
- 120 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
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.
Breast Density
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density.
- Trial name
- NCT05068388
- Testing
- Z-Endoxifen
- Where
- Sweden
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Atossa Therapeutics, Inc.
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
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
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.
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.
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
Uterine Fibroids
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two vaginal 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
- NCT02323646
- Testing
- Telapristone Acetate
- Where
- 8 sites in United States
- Volunteers
- 42 people
- Sponsor
- Repros Therapeutics Inc.
Uterine Fibroids
Extension of Study ZPV-200
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
- Trial name
- NCT01631903
- Testing
- telepristone acetate 12 mg, telepristone acetate 3 mg, telepristone acetate 6 mg
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Repros Therapeutics Inc.
Hypoactive Sexual Desire Disorder
2. 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 (NCT02338960)
- Testing
- Bremelanotide
- Where
- 91 sites in United States, Canada
- Volunteers
- 714 people
- Sponsor
- Palatin Technologies, Inc