Clinical trials: Postmenopausal Syndrome
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, Urinary Incontinence
Clinical Trial of "Magic Gyno" Laser Device
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose.
- Conditions
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome
- Trial name
- NCT05463081
- Testing
- Laser treatment, Blood test, Clinical urine test
- Where
- Russia
- Volunteers
- 70 people
- Sponsor
- MeLSyTech, Ltd
Vasomotor Syndrome
Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal…
- Trial name
- NCT06726850
- Testing
- GS1-144
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Vulvo Vaginal Atrophy (VVA)
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Study Objectives: Primary: To assess the safety, tolerability, and systemic pharmacokinetics (PK) of AZU-101 Secondary: To evaluate efficacy of daily vaginal doses of AZU-101 in postmenopausal women on vaginal epithelium
- Trial name
- NCT06197568
- Testing
- Lasofoxifene Tartrate
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Azure Biotech Inc.
Postmenopausal Symptoms
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
- Trial name
- NCT00727129
- Testing
- Divigel
- Volunteers
- 495 people
- Sponsor
- Upsher-Smith Laboratories
Postmenopausal Syndrome
Ex Vivo High-Throughput Assay for Vaginal Community Post-menopausal Women
This purpose of this study is to collect vaginal microbial samples of postmenopausal women to assess the optimal conditions for cultivation and storage of the vaginal microbiota.
- Trial name
- FLORA (NCT02415868)
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy
Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of these results to patients in the real-world setting is challenging, given RCTs are conducted in highly selected patient populations.
- Trial name
- Treat ER+ight (NCT02753686)
- Testing
- Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy
- Where
- 25 sites in Canada
- Volunteers
- 440 people
- Sponsor
- Novartis Pharmaceuticals
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
HIV Infections
A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen
- Trial name
- NCT01850212
- Where
- 73 sites in Austria, Belgium and 11 more
- Volunteers
- 476 people
- Sponsor
- Gilead Sciences
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
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or…
- Trial name
- NCT06783192
- Testing
- MK-8527, LNG/EE
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
- NCT00511953
- Testing
- Gabapentin Extended Release tablets, Gabapentin
- Where
- 8 sites in United States
- Volunteers
- 108 people
- Sponsor
- Depomed
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.
Polycystic Ovary Syndrome
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
- Trial name
- NCT03119077
- Testing
- BAY1161116, Itraconazole
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
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