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
Breast Cancer
Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
- Trial name
- NCT03936933
- Testing
- Goserelin acetate 3.6 mg Injection, ZOLADEX® 3.6mg Injection
- Where
- India
- Volunteers
- 6 people
- Sponsor
- Eurofarma Laboratorios S.A.
Healthy
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers…
- Trial name
- NCT04978688
- Testing
- Relugolix, E2/NETA
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Myovant Sciences GmbH
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
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
Nausea
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
- Trial name
- NCT03973047
- Testing
- Bremelanotide, Zofran
- Where
- United States
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
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 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
Vaginal Dysbiosis
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in…
- Trial name
- DISPALOMA (NCT06668012)
- Testing
- Palomacare® vaginal gel is a medical device with CE class IIa.
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Procare Health Iberia S.L.
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
Skin Aging, Weight Loss
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.
- Trial name
- NCT00352157
- Testing
- Revival Soy Dietary Supplement
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Physicians Pharmaceuticals, Inc.
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
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
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,466 people
- Sponsor
- Novartis Pharmaceuticals
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.