Clinical trials: Menopausal Women
Menopause
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal…
- Trial name
- NCT00196378
- Testing
- Synthetic Conjugated estrogens, B
- Where
- 38 sites in United States
- Volunteers
- 300 people
- Sponsor
- Duramed Research
Osteoporosis
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily…
- Trial name
- NCT00919711
- Testing
- Actonel®, Denosumab
- Volunteers
- 870 people
- Sponsor
- Amgen
Menopause, Hot Flashes
Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women.
- Trial name
- RENEW (NCT07834463)
- Testing
- Shatavari (Asparagus racemosus) Extract
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- India Glycols Ltd
Sleep Disturbances
Bonafide Sleep Supplement for Menopausal Women With Impaired Sleep
This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep.
- Trial name
- NCT07839299
- Testing
- S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Bonafide Health
Breast Cancer
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
- Trial name
- STRIDE (NCT00925548)
- Testing
- Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide, sodium chloride (NaCl)
- Where
- 29 sites in United States, Australia and 10 more
- Volunteers
- 16 people
- Sponsor
- EMD Serono
Post Menopausal Osteoporosis
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
- Trial name
- NCT00303485
- Testing
- Vitamin D and calcium supplementation, ibandronate [Bonviva/Boniva]
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Advanced Breast Cancer
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
- Trial name
- TELEPIK (NCT04862143)
- Testing
- Alpelisib, Fulvestrant, Goserelin
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic Breast Cancer
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
This is a multi-center, open-label, non-randomized, phase I study
- Trial name
- LeeBLet (NCT02154776)
- Testing
- LEE011, Buparlisib, Letrozole
- Where
- 6 sites in United States, Spain
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients
- Trial name
- SOSTA (NCT00727883)
- Volunteers
- 190 people
- Sponsor
- AstraZeneca
Atrophy, Vaginal Diseases
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
- Trial name
- NCT00276094
- Testing
- Ospemifene 30 mg, Ospemifene 60 mg, Nonhormonal vaginal lubricant
- Volunteers
- 826 people
- Sponsor
- Shionogi
Osteoporosis in Post-menopausal Women, Osteoporosis
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (HMM910 ) in postmenopausal women with osteoporosis who are at high risk of…
- Trial name
- NCT06949137
- Testing
- Human Umbilical Cord-derived Mesenchymal stem cell
- Where
- China
- Volunteers
- 9 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Advanced Breast Cancer
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion.
- Trial name
- NCT00793546
- Testing
- Bosutinib, exemestane
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 42 people
- Sponsor
- Pfizer
Breast Cancer
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study.
- Trial name
- NCT00880009
- Testing
- Bosutinib, Letrozole
- Where
- 11 sites in United States, Belgium and 5 more
- Volunteers
- 16 people
- Sponsor
- Pfizer
Menopause, Dietary Supplements
Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women
This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on…
- Conditions
- Menopause, Dietary Supplements, Quality of Life
- Trial name
- NCT04381026
- Testing
- Botanical dry extracts combination
- Where
- Spain
- Volunteers
- 57 people
- Sponsor
- Nektium Pharma SL
Menopausal Symptoms, Physical Activity and Sedentary Behavior
Prevalence of Menopause-associated Symptoms Throughout the Menopausal Transition in Women Aged 40 to 70 Residing in Spain and Its Relationship With Physical Activity - MdH Study
The goal of this observational study is to learn about menopause-related symptoms in women aged 40 to 70 years who live in Spain.
- Trial name
- NCT07596069
- Testing
- Reproductive stage, Physical Activity Level
- Where
- 2 sites in Spain
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Cuerpos Serranos S.L.
Post Menopausal Osteoporosis
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis.
- Trial name
- NCT00545480
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 190 sites in France
- Volunteers
- 596 people
- Sponsor
- Hoffmann-La Roche
Vaginismus, Vaginal Atrophy
Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours.
- Conditions
- Vaginismus, Vaginal Atrophy, Menopause
- Trial name
- NCT06564883
- Testing
- 0.20% sodium hyaluronate gel
- Volunteers
- 45 people
- Sponsor
- Biolab Sanus Farmaceutica
Menopause, Hot Flashes
The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal Women
The objective of this study is to evaluate the safety and efficacy of extended-release oxybutynin chloride for the treatment of vasomotor symptoms, also known as hot flashes, in healthy naturally postmenopausal women.
- Trial name
- NCT00990886
- Testing
- Oxybutynin chloride
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Atrophic Vaginitis, Vaginal Atrophy
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term…
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva
- Trial name
- VALOR (NCT05953090)
- Testing
- 7-0940
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Stratpharma AG
Uterine Fibroids
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
- Trial name
- NCT00882258
- Testing
- 12.5 mg Proellex, 25 mg Proellex
- Where
- 16 sites in United States
- Volunteers
- 144 people
- Sponsor
- Repros Therapeutics Inc.