Clinical trials: Premenopausal Women
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.
Uterine Fibroid, Myoma
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Trial name
- NCT03427671
- Testing
- Occlusin 500 Microspheres
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- IMBiotechnologies Ltd.
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
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
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.
Menstrual Wellness
Radicle Menstrual Wellness™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
- Trial name
- NCT07138339
- Testing
- Menstrual Wellness Product 1
- Where
- United States
- Volunteers
- 850 people, healthy volunteers welcome
- Sponsor
- Radicle Science
Psychological Phenomena and Processes
Types of Resistant Starch and Their Effect on Appetite
Investigators are interested in learning how appetite responds to certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber…
- Trial name
- NST (NCT01125878)
- Testing
- Starch composite B, Starch composite C, Starch composite D
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
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
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
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.
Uterine Fibroids
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women.
- Trial name
- NCT03886220
- Testing
- Elagolix
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 82 people
- Sponsor
- AbbVie
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
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
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
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
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
Sexual Dysfunctions, Psychological
Flibanserin Versus Placebo in Premenopausal Women With HSDD
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
- Trial name
- NCT00491829
- Testing
- 50 mg qhs, 100 mg
- Where
- 86 sites in Austria, Belgium and 11 more
- Volunteers
- 945 people
- Sponsor
- Sprout 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
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.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 1 (NCT03070899)
- Testing
- OBE2109, Add-back
- Where
- 116 sites in United States
- Volunteers
- 526 people
- Sponsor
- ObsEva SA
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
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.