Clinical trials: Menopausal
Perimenopausal Disorder, Stress, Emotional
The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk…
- Trial name
- Changes (NCT03003949)
- Testing
- Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release, Progesterone Capsule
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Menopause Hot Flashes
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
- Trial name
- NCT03291067
- Testing
- MT-8554 1mg, MT-8554 5mg, MT-8554 10mg
- Where
- 63 sites in United States
- Volunteers
- 375 people
- Sponsor
- Tanabe Pharma America, Inc.
Sexual Dysfunctions, Psychological
A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.
- Trial name
- NCT00441558
- Testing
- Flibanserin
- Where
- 196 sites in United States, Canada
- Volunteers
- 1,723 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Breast Cancer
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
- Trial name
- NCT02679755
- Testing
- Palbociclib, Letrozole
- Where
- 34 sites in Australia, India
- Volunteers
- 252 people
- Sponsor
- Pfizer
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the…
- Trial name
- NCT01157182
- Testing
- Estradiol/Norethindrone acetate, Activella®
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Vaginal Atrophy
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.
Post Menopausal Osteoporosis
MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium.
- Trial name
- NCT00048061
- Testing
- Ibandronate [Bonviva/Boniva], Calcium, Vitamin D
- Where
- 68 sites in United States, Australia and 17 more
- Volunteers
- 1,609 people
- Sponsor
- Hoffmann-La Roche
Menopausal Hot Flashes
Flushing Reduction Associated With Nitrates
A randomized, double-blinded, placebo-controlled trial of uninterrupted transdermal nitrate therapy in 140 peri- or postmenopausal women who have frequent hot flashes.
- Trial name
- FRAN (NCT02714205)
- Testing
- transdermal nitroglycerin
- Where
- 2 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Alison Huang, MD
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
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study.
- Trial name
- NCT00880009
- Testing
- Bosutinib, Letrozole
- Where
- 11 sites in United States, Belgium and 5 more
- Volunteers
- 16 people
- Sponsor
- Pfizer
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
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
Post-menopausal Vasomotor Symptoms
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients).
- Trial name
- NCT05325775
- Testing
- ACER-801 50 mg BID, ACER-801 100 mg BID, ACER-801 200 mg BID
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Acer Therapeutics Inc.
Menopause, Depression
Impact of Hot Flashes on Sleep and Mood Disturbance
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep…
- Conditions
- Menopause, Depression, Hot Flashes
- Trial name
- NCT01116401
- Testing
- leuprolide
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Symptomatic Menopause, Cognitive Impairments
Attention & Memory Impairments in Menopausal Women
The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working…
- Trial name
- NCT01324024
- Testing
- Lisdexamfetamine
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Cardiovascular Risk Factor, Health Behavior
Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
The goal of this study is to pilot test a 12-week behavioral intervention among perimenopausal Latinas (age 40-55 years) that integrates evidence-based education with physical activity, stress management, and coping skills…
- Conditions
- Cardiovascular Risk Factor, Health Behavior, Physical Activity, Self Efficacy
- Trial name
- NCT04313751
- Testing
- Education, Physical Activity, and Stress Management Program, Wait-list
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Postmenopausal Symptoms
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause.
- Trial name
- NCT03640754
- Testing
- G-CSF
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- MenoGeniX, Inc.
Advanced Breast Cancer
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion.
- Trial name
- NCT00793546
- Testing
- Bosutinib, exemestane
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 42 people
- Sponsor
- Pfizer