Clinical trials: Premenopausal Women
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
Premenstrual Syndrome, Menstrual Discomfort
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
This is a single-group, open-label, decentralized clinical trial evaluating the effects of the Kaia Relief - Cycle System (a commercial dietary supplement consisting of Day and Night capsules) on premenstrual symptom severity…
- Conditions
- Premenstrual Syndrome, Menstrual Discomfort, Premenstrual Symptoms
- Trial name
- NCT07876050
- Testing
- Kaia Relief - Cycle System (Day and Night)
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Vivance Group
Iron Deficiency (Without Anemia)
Efficacy of a Low Dose, Oral, Liquid Iron Supplement on Restoring Inadequate Blood Iron to Normal Levels
This is a randomized, double-blind, placebo-controlled, 8-week intervention clinical study assessing the safety and efficacy of a new low-dose liquid iron supplement in restoring iron levels to normal ranges without promoting…
- Trial name
- NCT05257343
- Testing
- Liquid Iron Supplement (Blood Builder ®)
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
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
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
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
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
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
Female Sexual Arousal Disorder
Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female Sexual Arousal Disorder
This study is looking to minimize side effects, while maintaining and potentially improving the therapeutic benefit to patients suffering from Female Sexual Arousal Disorder by providing a topical preparation of Sildenafil…
- Trial name
- RESPOND (NCT04948151)
- Testing
- Sildenafil
- Where
- 51 sites in United States
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Strategic Science & Technologies, LLC
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.
Pharmacokinetics
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol.
- Trial name
- NCT02170038
- Testing
- Microgynon, Noristerat(BAY86-6308)
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
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
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.
Hypoactive Sexual Desire Disorder
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).
- Trial name
- NCT04943068
- Testing
- Bremelanotide
- Where
- South Korea
- Volunteers
- 193 people
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
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.
Menstruation Disorders
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol.
- Trial name
- NCT00467493
- Testing
- Anastrozole
- Where
- 2 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Meditrina Pharmaceuticals
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
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
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.
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.