Clinical trials: Pre-Menopause
Vulvovaginal Atrophy, Dyspareunia
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks.
- Trial name
- NCT02784613
- Testing
- Ospemifene
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sue Goldstein
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
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
Pre-Diabetic
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.
- Trial name
- NCT04286529
- Testing
- Calcitriol capsules
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Insulin Sensitivity, Cardiovascular Risk
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to…
- Conditions
- Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder
- Trial name
- NCT01475513
- Testing
- Ortho Cyclen®
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
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.
Alcohol Drinking, Weight Loss
The Effects of Alcohol Consumption on Central Adiposity
The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating…
- Conditions
- Alcohol Drinking, Weight Loss, Adiposity, Obesity
- Trial name
- CONSUME (NCT03521817)
- Testing
- Alcohol, No Alcohol
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
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
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.
Metastatic Breast Cancer
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after…
- Trial name
- NCT01528345
- Testing
- Dovitinib, Fulvestrant
- Where
- 67 sites in United States, Argentina and 13 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
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
Menopause, Obesity
Brown Adipose Tissue Activity in Pre- and Postmenopausal Women
The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The investigators have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is…
- Trial name
- NCT02927392
- Testing
- Leuprolide acetate
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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