Clinical trials: Premenopausal
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
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, 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
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
Japanese Premenopausal Healthy Adult Women
A Food Effect Study of TAK-385 Final Formulation
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
- Trial name
- NCT02792062
- Testing
- TAK-385 40 mg
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Endometriosis Pelvic, Endometriosis Ovaries
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
PRECISION-E2 is a Phase IIa randomized, placebo-controlled study evaluating the pharmacodynamic profile, safety and tolerability of teverelix in premenopausal women with moderate-to-severe pain associated with endometriosis in…
- Conditions
- Endometriosis Pelvic, Endometriosis Ovaries, Premenopausal, Endometriosis (Diagnosis)
- Trial name
- NCT07914062
- Testing
- Teverelix DP
- Volunteers
- 84 people
- Sponsor
- Antev Ltd.
Endometriosis
The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.
The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis.
- Trial name
- NCT04417972
- Testing
- SHR7280
- Where
- China
- Volunteers
- 179 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hepatitis C, Chronic
Drug-drug Interaction of BI 201335 and Microgynon
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
- Trial name
- NCT01570244
- Testing
- levonorgestrel, Ethinylestradiol, BI 201335
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar 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.
Focus: Understanding the Obesogenic Potential of Sugars and Non-caloric Sweeteners
The Effect of Sugar Sweetened and Diet Beverages Consumed as Part of a Weight-Maintenance Diet on Fat Storage
The purpose of this study is to investigate the effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism.
- Trial name
- NCT02252952
- Testing
- Beverage Consumption
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Rippe Lifestyle Institute
Cyclic Breast Pain, Cyclic Mastalgia
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women
The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking…
- Trial name
- NCT00272714
- Testing
- Afimoxifene (0.057%) in hydroalcoholic gel
- Volunteers
- 146 people
- Sponsor
- ASCEND Therapeutics
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.
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.
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 Cancer Subjects
Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
- Trial name
- NCT06449027
- Testing
- T Leuprolide Injectable Emulsion, Leuprorelin Acetate Microspheres for Injection
- Where
- China
- Volunteers
- 211 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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