Clinical trials: Climacteric Symptoms
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
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Vasomotor Symptoms
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause.
- Trial name
- NCT00401245
- Testing
- desvenlafaxine succinate sustained release
- Where
- 74 sites in United States, Canada
- Volunteers
- 500 people
- Sponsor
- Pfizer
Menopause
Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
- Trial name
- NCT00962585
- Testing
- S-equol
- Where
- 9 sites in United States, Australia
- Volunteers
- 169 people
- Sponsor
- Ausio Pharmaceuticals, LLC
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Gynecology
An Endometrial Cancer Chemoprevention Study of Metformin
The goal of this clinical research study is to learn about the effects of metformin and/or a program called "lifestyle intervention" on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese…
- Trial name
- NCT01697566
- Testing
- Metformin, Endometrial Biopsy, Lifestyle Intervention
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Obesity
Females, Aging, Metabolism, and Exercise
This study is designed to determine whether a reduction in hormones (such as occurs during menopause) causes a decrease in calories burned during physical activity.
- Trial name
- FAME (NCT01712230)
- Testing
- GnRH agonist, Supervised cardiovascular exercise
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Menopause, Hot Flashes
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes.
- Trial name
- NCT03192176
- Testing
- Fezolinetant
- Where
- 51 sites in United States
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Hot Flashes
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 2 (NCT04003142)
- Testing
- Fezolinetant
- Where
- 93 sites in United States, Canada and 5 more
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Menopause, Osteoporosis
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.
- Conditions
- Menopause, Osteoporosis, Osteopenia
- Trial name
- SPARE (NCT00076050)
- Testing
- Soy isoflavones
- Where
- United States
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- University of Miami
Microscopic Hematuria
Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women.
- Trial name
- EVER (NCT02213757)
- Testing
- Premarin vaginal estrogen cream
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Medstar Health Research Institute
Hot Flashes
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined…
- Trial name
- NCT00786188
- Testing
- Brisdelle (paroxetine mesylate), Sugar pill
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Noven Therapeutics
Menopause, Irritable Mood
Estrogen Variability and Irritability During the Menopause Transition
Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk.
- Trial name
- NCT05388656
- Testing
- Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release, Progesterone 200 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Postmenopausal Symptoms
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.
- Trial name
- N30-003 (NCT01361308)
- Testing
- Brisdelle (paroxetine mesylate)
- Where
- 74 sites in United States
- Volunteers
- 614 people
- Sponsor
- Noven Therapeutics
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Genitourinary System; Disorder, Female, Burning Vagina
Laser Therapy for Treatment of Urogenital Symptoms in Women
This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.
- Conditions
- Genitourinary System; Disorder, Female, Burning Vagina, Dyspareunia, Irritation; Vagina
- Trial name
- NCT03681678
- Testing
- fCO2 Laser Therapy Group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Corewell Health East
Vasomotor Symptoms; Hot Flashes
Study of Erenumab (AMG 334) in Women With Hot Flashes
The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.
- Trial name
- NCT01890109
- Testing
- Erenumab
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- Amgen
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
Hot Flashes
Breathe for Hot Flashes Randomized Controlled Trial
Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence.
- Trial name
- NCT00819182
- Testing
- Paced respiration
- Where
- United States
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Indiana University