Clinical trials: Menopausal
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
Postmenopausal Osteoporosis, Gut Microbiota
Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.
- Conditions
- Postmenopausal Osteoporosis, Gut Microbiota, Cardiovascular Diseases
- Trial name
- NCT04431960
- Testing
- blackcurrant (BC) extract
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
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.
Breast Cancer, Hot Flashes
Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy
RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and quality of life in postmenopausal women not…
- Conditions
- Breast Cancer, Hot Flashes, Menopausal Symptoms, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00956813
- Testing
- flaxseed
- Where
- 107 sites in United States
- Volunteers
- 210 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Vasomotor Symptoms Associated With Menopause, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause
Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the…
- Trial name
- OASIS-1 (NCT05042362)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 99 sites in United States, Austria and 6 more
- Volunteers
- 396 people
- Sponsor
- Bayer
Atrophic Vaginitis, Menopause
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.
- Trial name
- VeLVET (NCT02691936)
- Testing
- CO2 fractionated vaginal laser, Estrogens, Conjugated (USP)
- Where
- 6 sites in United States
- Volunteers
- 69 people
- Sponsor
- The Cleveland Clinic
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
Vasomotor Symptoms
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.
- Trial name
- NCT00683800
- Testing
- desvenlafaxine succinate (DVS) SR
- Where
- 121 sites in United States, Canada
- Volunteers
- 2,186 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Post Menopausal Osteoporosis
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment.
- Trial name
- NCT02598934
- Testing
- Ibandronate
- Where
- 53 sites in United States, Puerto Rico
- Volunteers
- 308 people
- Sponsor
- Hoffmann-La Roche
Osteoporosis
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post…
- Trial name
- NCT00489424
- Testing
- Acetaminophen, Fluvastatin
- Where
- United States
- Volunteers
- 793 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
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
Breast Cancer
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
The purpose of this study is to learn about the effects of the study medicine PF-07220060 plus letrozole, compared with the effects of taking letrozole alone without PF-07220060 for treatment of breast cancer.
- Trial name
- NCT06465368
- Testing
- PF-07220060, letrozole
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 121 people
- Sponsor
- Pfizer
Breast Carcinoma, Breast Ductal Carcinoma In Situ
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women.
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Hot Flashes
- Trial name
- NCT05086705
- Testing
- EMBr Wave, Questionnaire Administration
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Sleep Disturbances Associated With Menopause
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop.
- Trial name
- NIRVANA (NCT06112756)
- Testing
- Elinzanetant
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 110 people
- Sponsor
- Bayer
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
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