Clinical trials: Postmenopausal Syndrome
Obesity, Glucose Homeostasis
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs.
- Conditions
- Obesity, Glucose Homeostasis, Postmenopausal Symptoms
- Trial name
- BIM (NCT02237079)
- Testing
- Bazedoxifene/Conjugated Estrogens (BZA/CE)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Tulane University Health Sciences 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
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Dyspareunia
Treating Postmenopausal Dyspareunia Where it Hurts
The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women.
- Trial name
- NCT03240081
- Testing
- 50mcg estradiol cream, 100mcg estradiol cream
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Vaginal Atrophy, Postmenopausal Symptoms
Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors
The purpose of this research is to gather information on the safety and effectiveness of Intrarosa®, also known as Dehydroepiandrosterone (DHEA), and prasterone.
- Conditions
- Vaginal Atrophy, Postmenopausal Symptoms, Breast Cancer Female, Long-term Survivors
- Trial name
- NCT04493333
- Testing
- Vaginal Dehydroepiandrosterone, Vaginal Polycarbophil Moisturizer
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Arkansas
Postmenopausal Symptoms, Aging
Cholinergic Health After Menopause (CHAMP)
Women are at increased risk for Alzheimer's disease (AD). Notably at menopause, some women experience a change in cognition. However, not all women experience negative effects of menopause on cognition.
- Conditions
- Postmenopausal Symptoms, Aging, Alzheimer Disease
- Trial name
- CHAMP (NCT04129060)
- Testing
- Cholinergic antagonist
- Where
- 2 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- University of Vermont
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
Hot Flashes
Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women
- Trial name
- NCT00777023
- Testing
- Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg
- Where
- 45 sites in United States
- Volunteers
- 565 people
- Sponsor
- Depomed
Sexual Pain Disorders, Postmenopausal Symptoms
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source…
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction
- Trial name
- NCT03682601
- Testing
- 5% sinecatechins ointment, 10% sinecatechins ointment
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GTO Pharmaceutical, LLC
Menopausal Syndrome
Early Menopause Hormone Treatment and Cognition
The objective of this study is to evaluate the neurobiological effects of hormone therapy (HT) in healthy early postmenopausal women.
- Trial name
- R21 (NCT01046643)
- Testing
- Estradiol (E2), Progesterone (P10) x90, Progesterone (P10) x10
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Memory Loss, Cognitive Changes
Aging and Estrogen on Cortical Function
This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.
- Conditions
- Memory Loss, Cognitive Changes, Postmenopausal Symptoms
- Trial name
- NCT01268046
- Testing
- Estradiol oral capsule, transderman estrogen patch
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Human Immunodeficiency Virus
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
- Trial name
- NCT02010593
- Testing
- Dapivirine Vaginal Ring
- Where
- 3 sites in United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Menopause Related Conditions, Postmenopausal Symptoms
Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness
This investigation is designed to demonstrate the safety and efficacy of the VR101 lubricating intravaginal ring (IVR) in treating the symptoms of vaginal dryness.
- Trial name
- NCT03150407
- Testing
- VR101 Device (Efficacy), VR101 Device (Safety)
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- J3 Bioscience, Inc.
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Postmenopause
Endometrial Safety Study
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
- Trial name
- NCT00522873
- Testing
- 0.25mg DRSP / 0.5mg E2 (BAY86-4891), 0.5mg NETA / 1.0mg E2 (Activella)
- Where
- 59 sites in United States, Argentina and 6 more
- Volunteers
- 662 people
- Sponsor
- Bayer
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.
Postmenopausal Symptoms
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and…
- Trial name
- N30-005 (NCT01829919)
- Testing
- Brisdelle (paroxetine mesylate)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Noven Therapeutics
Hot Flashes
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
Depomed's Gabapentin Extended Release (G-ER) is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
- Trial name
- NCT00755417
- Testing
- Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg
- Where
- 45 sites in United States
- Volunteers
- 541 people
- Sponsor
- Depomed
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals