Clinical trials: Climacteric 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
Menopause, Hot Flashes
A Double-Blind Study to Evaluate the Effect of Femarelle® on Menopausal on Vasomotor Symptoms
The purpose of this study is to test the effects of Femarelle ( a plan-derived SERM) on hot flushes and quality of life in menopausal women.
- Trial name
- NCT01063725
- Testing
- Femarelle
- Where
- 5 sites in Israel
- Volunteers
- 200 people
- Sponsor
- Se-cure Pharmaceuticals Ltd.
Menopause, Vasomotor; Syndrome
Efficacy of Nano-Pso Therapy in Menopause
Vasomotor syndrome is prevalent in 85% of postmenopausal women, hormone therapy in menopause is first-line therapy, but 38% of patients have some contraindication for its use.
- Trial name
- NCT06432816
- Testing
- NANO-PSO
- Where
- Mexico
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Distribuidora Biolife SA de CV
Vaginal Atrophy Patients With GSM
The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM)
Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer.
- Trial name
- NCT06318052
- Testing
- The FemTouch delivery system, Gynomunal gel treatment
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Lumenis Be Ltd.
Premenstrual Syndrome, Premenstrual Dysphoric Disorder
CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life
This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device…
- Conditions
- Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Dysmenorrhea, Endometriosis
- Trial name
- CREST (NCT07679074)
- Testing
- Lutea Transcranial Direct Current Stimulation (tDCS) Device, Samphire Guided Care Program
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Samphire Group, Inc.
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
Menopause Syndrome
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer…
- Trial name
- NCT05263102
- Testing
- Vaginal Moisturizing Gel
- Where
- 4 sites in Taiwan
- Volunteers
- 80 people
- Sponsor
- HAN Biomedical Inc
Menopause, Hormone Replacement Therapy
Menopausal Vaginal Microbiome
In this study the investigators will analyze the vaginal microbiome of menopausal women in order to shed light on its potential implication on menopausal symptoms and quality of life.
- Conditions
- Menopause, Hormone Replacement Therapy, Genitourinary Syndrome of Menopause
- Trial name
- NCT05122065
- Volunteers
- 432 people, healthy volunteers welcome
- Sponsor
- FemTec Health Inc.
Dry Eye Syndromes
Effects of RP101 in Post-menopausal Women With Dry Eye Syndrome
The main purpose of this study is to establish whether RP101 can reduce symptoms of dry eye syndrome in post-menopausal women.
- Trial name
- NCT03821415
- Testing
- RP101
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 104 people
- Sponsor
- Redwood Pharma AB
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life.
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause (GSM), Quality of Life
- Trial name
- NCT07737782
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Mucosa Innovations, S.L.
Menopausal Syndrome
A Randomized, Double-Blind, Parallel, Non-Inferiority, Multicenter Trial Evaluate the Efficacy and Safety of UNCNT Compared to MELSMON in Female With Menopausal Syndrome
The Purpose of this study is to evaluate in a randomized, double-blind, Parallel, Non-inferiority, Multicenter, the efficacy and safety of UNCNT in comparison to the active comparator of MELSMON in female having menopausal…
- Trial name
- UNCNT (NCT01931748)
- Testing
- MELSMON, UNCNT
- Where
- 2 sites in South Korea
- Volunteers
- 104 people
- Sponsor
- Unimed Pharmaceuticals
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
Climacteric Syndrome
Efficacy and Safety of Passiflora Incarnata and Isoflavona Combination in the Treatment of Climacteric Symptoms
The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.
- Trial name
- Monalisa (NCT01695616)
- Testing
- Active drug
- Where
- Brazil
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Genitourinary Syndrome of Menopause
Zinc Containing Vaginal Topical " Suppository "
The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract.
- Trial name
- NCT05453227
- Testing
- Zinc
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Egymedicalpedia
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.
Chronic Pain, Appetite Disorders
The JULI Registry--Hemp and Cannabis Observational Registry
The JuLi Registry seeks to fill some of the gaps associated with the clinical use of CBD (cannabidiol) and other cannabinoid formulations including THC and others.
- Conditions
- Chronic Pain, Appetite Disorders, Neuropathy, Menopausal Syndrome
- Trial name
- JULI (NCT04726254)
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Juva Life
Menopause, Climacteric Syndrome
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome
- Conditions
- Menopause, Climacteric Syndrome, Metabolic Syndrome
- Trial name
- NCT06057896
- Testing
- inositol, phytoestrogens, cocoa polyphenols
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Lo.Li.Pharma s.r.l
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.
Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, such as hot flashes. Before a treatment can be approved for patients to take, researchers do clinical studies to better…
- Trial name
- NCT05028608
- Testing
- Elinzanetant (BAY3427080), Midazolam, Carbamazepine
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Vaginal Atrophy, Sexual Dysfunction
Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause
This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.
- Conditions
- Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness
- Trial name
- NCT03178825
- Testing
- Hybrid Fractional Laser
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sciton
Vaginal Atrophy, Genitourinary Disease
Effect of Hybrid Laser 10600+1540 nm on GSM
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser…
- Trial name
- NCT03956563
- Testing
- Youlaser MT Group 2, Youlaser MT Group 1
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Quanta System, S.p.A.