Clinical trials: Menopause
Perimenopause, Menopause
Perimenopausal Estrogen Replacement Therapy Study
Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in CVD rates relate to the burden of CV risk in women after the menopause.
- Conditions
- Perimenopause, Menopause, Depression
- Trial name
- PERT (NCT01308814)
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Post Menopausal Women With Early Breast Cancer
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire. Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).
- Trial name
- FAST (NCT01050634)
- Testing
- Aromasin (exemestane)
- Volunteers
- 980 people
- Sponsor
- Pfizer
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
Hot Flashes
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 4 (NCT04003389)
- Testing
- fezolinetant
- Where
- 182 sites in United States, Canada and 6 more
- Volunteers
- 1,831 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Vasomotor Symptoms, Menopausal Symptoms
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
A two-part study designed to evaluate the effect of Estetrol (E4) 15 mg, 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) in the Efficacy Study Part and the safety of E4 20 mg in the Safety Study Part.
- Trial name
- E4Comfort II (NCT04090957)
- Testing
- Estetrol oral tablet
- Where
- 117 sites in United States, Canada
- Volunteers
- 1,015 people, healthy volunteers welcome
- Sponsor
- Estetra
Hypertension
Effect of Azilsartan on Aldosterone in Postmenopausal Females
The purpose of the research is to evaluate the effect of azilsartan medoximil on blood pressure and urinary aldosterone levels in postmenopausal females.
- Trial name
- NCT01774591
- Testing
- Azilsartan medoximil
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Chicago
Post-Menopausal Osteoporosis
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal…
- Trial name
- NCT00503113
- Testing
- ibandronate [Bonviva/Boniva], Alendronate
- Where
- 44 sites in United States, Argentina and 4 more
- Volunteers
- 801 people
- Sponsor
- Hoffmann-La Roche
Moderate Depression, Menopausal and Postmenopausal Disorders
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.
- Trial name
- HOMDEP-MENOP (NCT01635218)
- Testing
- Individualized homeopathic treatment, Fluoxetine
- Where
- Mexico
- Volunteers
- 133 people
- Sponsor
- Hospital Juarez de Mexico
Central Obesity
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body…
- Trial name
- NCT02375113
- Testing
- soy supplementation
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- The University of Texas at San Antonio
Post-Menopausal Osteoporosis
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP)…
- Trial name
- NCT03432533
- Testing
- romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen
- Where
- 46 sites in United States, Poland and 1 more
- Volunteers
- 283 people
- Sponsor
- Amgen
Menopause, Osteoporosis
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal…
- Trial name
- NCT00808132
- Testing
- bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg, bazedoxifene 20 mg
- Where
- 178 sites in United States, Argentina and 10 more
- Volunteers
- 1,886 people
- Sponsor
- Pfizer
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Menopause
Bioidentical 'Natural' Hormone Evaluation in Early Menopause
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled.
- Trial name
- NCT00302731
- Testing
- Estradiol , estriol , progesterone, estradiol, progesterone, estriol, progesterone
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Jeanne Drisko, MD, CNS, FACN
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
Hot Flashes, Menopause
MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
The purpose of this study is to test whether a medication reduces the number, severity and bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective serotonin reuptake inhibitor (SSRI).
- Conditions
- Hot Flashes, Menopause, Vasomotor Symptoms
- Trial name
- NCT00894543
- Testing
- Escitalopram
- Where
- 5 sites in United States
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Pelvic Organ Prolapse, Menopause
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall.
- Trial name
- PET (NCT01778985)
- Testing
- Premarin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Bone Loss, Post Menopausal Osteoporosis
Lactobacillus Acidophilus and Postmenopausal Women
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
- Conditions
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- Trial name
- LaBon (NCT05332626)
- Testing
- Probiotic group
- Where
- Poland
- Volunteers
- 90 people
- Sponsor
- Poznan University of Life Sciences
Breast Cancer
PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes.
- Trial name
- NCT00499681
- Testing
- lapatinib ditosylate, letrozole
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Menopause
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major…
- Trial name
- NCT01933295
- Testing
- Cognitive Behavioral Therapy for Insomnia, Sleep Education, Sleep Restriction Therapy
- Where
- United States
- Volunteers
- 154 people
- Sponsor
- Christopher Drake
Metastatic Breast Cancer
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
- Trial name
- NCT00634634
- Testing
- Sorafenib, Letrozole
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Rutgers, The State University of New Jersey