Clinical trials: Premenopausal
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
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.
Menstrual Cycle, Exercise Treadmill
The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women
False positive results are commonly observed in women after exercise treadmill test (ETT). The effects of menstrual cycle on the results of ETT in premenopausal women have not been clearly defined.
- Trial name
- NCT05985980
- Testing
- Exercise Treadmill Test (ETT)
- Where
- Turkey (Türkiye)
- Volunteers
- 47 people
- Sponsor
- Istanbul Medeniyet University
Uterine Fibroids
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
- Trial name
- NCT01451424
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Sexual Dysfunctions, Psychological
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
- Trial name
- NCT00601367
- Testing
- flibanserin flexible dose
- Where
- 68 sites in Austria, Belgium and 10 more
- Volunteers
- 480 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Breast Cancer
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.
- Trial name
- NCT00293540
- Testing
- oophorectomy, Tamoxifen
- Where
- 21 sites in United States, Bangladesh and 8 more
- Volunteers
- 249 people
- Sponsor
- International Breast Cancer Research Foundation
Breast Cancer
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive…
- Trial name
- NCT00201851
- Testing
- Tamoxifen, Surgery: Oophorectomy
- Where
- 9 sites in Morocco, Philippines and 1 more
- Volunteers
- 740 people
- Sponsor
- International Breast Cancer Research Foundation
Breast Cancer
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years.
- Trial name
- NCT00903162
- Testing
- leuprolide, letrozole, zoledronic acid
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
This phase III trial studies how well metformin hydrochloride works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer.
- Conditions
- Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ
- Trial name
- NCT01905046
- Testing
- metformin hydrochloride
- Where
- 27 sites in United States
- Volunteers
- 86 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Anorexia Nervosa, Osteoporosis
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
- Trial name
- 1180 (NCT02475265)
- Testing
- estradiol 0.045 mg/levonorgestrel 0.015mg
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital
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
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
Sexual Dysfunctions, Psychological
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.
- Trial name
- NCT00996164
- Testing
- Flibanserin
- Where
- 75 sites in United States
- Volunteers
- 1,090 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Coronary Heart Disease
Relationship Between the Menstrual Cycle and Heart Disease in Women
Women who have regular menstrual cycles have a lower risk of heart disease than men of the same age or women who no longer have menstrual cycles.
- Trial name
- NCT01546454
- Testing
- Ethinyl Estradiol-Levonorgestrel combination, leuprolide acetate, Estradiol
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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
- NCT00735553
- Testing
- Proellex
- Where
- 15 sites in United States
- Volunteers
- 77 people
- Sponsor
- Repros Therapeutics Inc.
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT01368263
- Testing
- goserelin acetate, letrozole, anastrozole
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"
The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit)…
- Trial name
- NCT02134977
- Testing
- Leuprorelin Acetate
- Volunteers
- 2,816 people
- Sponsor
- Takeda
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
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