Clinical trials: Pre-Menopause
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment.
- Trial name
- NCT00702702
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 30 sites in United States
- Volunteers
- 56 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer, Cancer of the Breast
Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer
This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.
- Conditions
- Breast Cancer, Cancer of the Breast, Breast Neoplasm
- Trial name
- NCT00530868
- Testing
- Letrozole (Femara), Letrozole; Avastin
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- University of Alabama at Birmingham
Premenopause, Healthy
Effect of Race on Gonadotropin Responses
The purpose of this study is to attempt to determine why estrogen levels are increased in African-American women as compared to Caucasian women by evaluating estrogen feedback on the brain.
- Trial name
- NCT00455962
- Testing
- Estradiol steroid infusion, Progesterone steroid infusion
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Advanced Breast Cancer
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of…
- Trial name
- NCT00322348
- Testing
- Goserelin acetate
- Where
- 14 sites in Czechia, Russia and 1 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Endometriosis
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe…
- Trial name
- ELENA (NCT05560646)
- Testing
- OG-6219
- Where
- 86 sites in United States, Belgium and 9 more
- Volunteers
- 354 people
- Sponsor
- Organon and Co
Estrogen Receptor-positive Breast Cancer, Progesterone Receptor Positive Tumor
Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes.
- Conditions
- Estrogen Receptor-positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT01385280
- Testing
- therapeutic estradiol, exemestane, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Arizona
Estrogen Deficiency, Cardiovascular Disease (CVD)
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
The purpose of this study is to determine whether young women with functional hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for pre-clinical cardiovascular disease (CVD).
- Conditions
- Estrogen Deficiency, Cardiovascular Disease (CVD), Functional Hypothalamic Amenorrhea, Endothelial Dysfunction
- Trial name
- NCT03018366
- Testing
- 17beta Estradiol, Progesterone
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Uterine Fibroids
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
- Trial name
- NCT00958334
- Testing
- Proellex®
- Where
- 11 sites in United States
- Volunteers
- 65 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage…
- Trial name
- EMBER-2 (NCT04647487)
- Testing
- LY3484356
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 87 people
- Sponsor
- Eli Lilly and Company
Polycystic Ovarian Syndrome, Infertility
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF).
- Trial name
- NCT00805935
- Testing
- Menotropin, Progesterone vaginal insert, Follitropin beta
- Where
- 6 sites in United States
- Volunteers
- 110 people
- Sponsor
- Ferring Pharmaceuticals
Cardiovascular Risk Reduction
Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women
Researchers are trying to assess the appropriate dose of estrogen for decreasing the risk of cardiovascular disease in women who have removal of their ovaries at a young age, before the age of 46 years.
- Trial name
- NCT03815929
- Testing
- Estradiol 100 Micrograms Patch, Estradiol Patch
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Menopause, Depression
Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder
The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS).
- Trial name
- NCT00626340
- Testing
- MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment, MDD diagnosis with both Estrogen and Fluoxetine treatment
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Hypoactive Sexual Desire Disorder
Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated.
- Trial name
- NCT02770768
- Testing
- Flibanserin
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- University of Chicago
Breast Cancer
Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
The investigators will study the effect of 12 months of SDG (Brevail) vs placebo on women at increased risk for development of breast cancer.
- Trial name
- NCT01276704
- Testing
- secoisolariciresinol
- Where
- 7 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Carol Fabian, MD
Ovarian Cancer
Optimal Timing of BR55 CEUS of the Ovaries
This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal…
- Trial name
- NCT04248153
- Testing
- BR55
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Bracco Diagnostics, Inc
Uterine Fibroids, Anemia
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
- Trial name
- NCT00785356
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 7 sites in Mexico
- Volunteers
- 8 people
- Sponsor
- Repros Therapeutics Inc.
Relapsing Multiple Sclerosis (RMS)
Effects of Cladribine Tablets on the PK of Microgynon®
The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and…
- Trial name
- NCT03745144
- Testing
- Cladribine, Microgynon®
- Where
- 7 sites in Germany, Poland
- Volunteers
- 28 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
MENOPUR® Versus FOLLISTIM®
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF)…
- Trial name
- NCT00802360
- Testing
- Menotropin, Progestrone vaginal insert, follitropin beta
- Where
- 7 sites in United States
- Volunteers
- 173 people
- Sponsor
- Ferring Pharmaceuticals
Breast Cancer
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced…
- Trial name
- NCT01073865
- Testing
- ZD9393 (Zoladex) 10.8 mg, ZD9393 (Zoladex) 3.6 mg
- Where
- 55 sites in India, Japan and 4 more
- Volunteers
- 222 people
- Sponsor
- AstraZeneca