Clinical trials: Menopausal Women
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.
Chronic Kidney Disease, Secondary Hyperparathyroidism
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol…
- Trial name
- QUALITIZE (NCT01368042)
- Where
- 11 sites in Greece
- Volunteers
- 265 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Postmenopausal Osteoporosis
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
- Trial name
- NCT00293813
- Testing
- Alendronate, Denosumab
- Volunteers
- 247 people
- Sponsor
- Amgen
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Breast Cancer
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole
- Trial name
- REAL (NCT00688909)
- Testing
- letrozole
- Where
- 48 sites in United States
- Volunteers
- 261 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
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
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
Breast Cancer
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..
- Trial name
- ZACFAST (NCT00752986)
- Testing
- ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant, ZD6474 (Vandetanib at the dose of 300 mg)
- Where
- 11 sites in Italy
- Volunteers
- 39 people
- Sponsor
- Genzyme, a Sanofi Company
Post-menopausal Vasomotor Symptoms
Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts.
- Trial name
- RELENT-1 (NCT02865538)
- Testing
- BAY3427080
- Where
- 3 sites in United States
- Volunteers
- 76 people
- Sponsor
- Bayer
Menopause
A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.
- Trial name
- REPLENISH (NCT01942668)
- Testing
- Estradiol, Progesterone
- Where
- 119 sites in United States
- Volunteers
- 1,845 people
- Sponsor
- TherapeuticsMD
Vasomotor Symptoms, Menopausal Symptoms
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
A two-part study designed to evaluate the effect of Estetrol (E4) 15 mg, 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) in the Efficacy Study Part and the safety of E4 20 mg in the Safety Study Part.
- Trial name
- E4Comfort II (NCT04090957)
- Testing
- Estetrol oral tablet
- Where
- 117 sites in United States, Canada
- Volunteers
- 1,015 people, healthy volunteers welcome
- Sponsor
- Estetra
Menopause Hot Flashes
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
- Trial name
- NCT03291067
- Testing
- MT-8554 1mg, MT-8554 5mg, MT-8554 10mg
- Where
- 63 sites in United States
- Volunteers
- 375 people
- Sponsor
- Tanabe Pharma America, Inc.
Endometrial Cancer
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
- Trial name
- NCT01251354
- Testing
- BN83495
- Where
- 9 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- Ipsen
Post-Menopausal Osteoporosis
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP)…
- Trial name
- NCT03432533
- Testing
- romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen
- Where
- 46 sites in United States, Poland and 1 more
- Volunteers
- 283 people
- Sponsor
- Amgen
Vaginal Atrophy
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01358760
- Testing
- DHEA
- Where
- 42 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- EndoCeutics Inc.
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
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
Uterine Fibroids
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
- Trial name
- NCT00958334
- Testing
- Proellex®
- Where
- 11 sites in United States
- Volunteers
- 65 people
- Sponsor
- Repros Therapeutics Inc.
Post Menopausal Osteoporosis
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.).
- Trial name
- NCT00377234
- Testing
- Risedronate, ibandronate [Bonviva/Boniva]
- Where
- 48 sites in United States
- Volunteers
- 356 people
- Sponsor
- Hoffmann-La Roche