Clinical trials: Pre-menopause
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
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
Contraceptive Usage, Overweight or Obesity
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC).
- Conditions
- Contraceptive Usage, Overweight or Obesity, Body Weight Changes, Appetitive Behavior
- Trial name
- NCT05061472
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Breast Cancer
Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer
This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming.
- Trial name
- NCT00853996
- Testing
- acolbifene hydrochloride
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of Kansas 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.
Endometriosis
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last…
- Trial name
- NCT01728454
- Testing
- Telapristone acetate
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
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
Breast Cancer Female
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers.
- Trial name
- NCT03747042
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Uterine Fibroids
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
- Trial name
- NCT00683917
- Testing
- Proellex 25 mg, Proellex 50 mg, Lupron Depot
- Where
- 4 sites in United States, Mexico
- Volunteers
- 10 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.
- Trial name
- AMEERA-4 (NCT04191382)
- Testing
- Amcenestrant (SAR439859), Letrozole
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 105 people
- Sponsor
- Sanofi
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
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
Breast Cancer
Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal and post-menopausal women before and after exposure to one of the two commonly used breast cancer drugs, tamoxifen or fulvestrant.
- Trial name
- NCT02936206
- Testing
- Fulvestrant, Tamoxifen
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Metastatic Breast Cancer
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone
This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on…
- Trial name
- NCT05012644
- Testing
- Palbociclib + aromatase inhibitor, Aromatase inhibitor
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- Pfizer
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
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
Menopause, Premenopause
MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making
As part of a National Institute on Aging -funded R01, the investigators developed an evidence-based, multi-media digital resource entitled MyMenoPlan to help women learn about the menopause transition, and the symptoms and…
- Conditions
- Menopause, Premenopause, Postmenopause
- Trial name
- NCT05299983
- Testing
- MyMenoPlan, Control
- Where
- United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Breast Cancer
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are…
- Trial name
- NCT00259090
- Testing
- Fulvestrant, Anastrazole
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Elevated Blood Pressure, Endothelial Dysfunction
Effectiveness of Vitamin D Supplementation
This pilot study will examine the effectiveness of vitamin D supplementation on reducing blood pressure and improving endothelial function. Premenopausal African American women will be recruited.
- Trial name
- NCT02513823
- Testing
- 2,000 International Units (IU)of vitamin D3
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Texas Woman's University