Clinical trials: Vasomotor Symptoms
Hot Flashes
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined…
- Trial name
- NCT00786188
- Testing
- Brisdelle (paroxetine mesylate), Sugar pill
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Noven Therapeutics
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer…
- Trial name
- OASIS-4 (NCT05587296)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 102 sites in Austria, Belgium and 14 more
- Volunteers
- 474 people
- Sponsor
- Bayer
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
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women
Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants
This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones.
- Trial name
- NCT07762287
- Testing
- Elinzanetant (BAY 3427080) treatment A, Elinzanetant (BAY 3427080) treatment B
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bayer
Stable Angina
Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated With Bioresorbable and Metallic Stents at 1 Year
Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with metallic stent implantation remain with effort angina despite optimal medical treatment and absence of stent restenosis at 1 year.
- Trial name
- BVS-Flow (NCT02738658)
- Testing
- Bioresorbable vascular scaffold, Everolimus-eluting stent
- Where
- 3 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Vasomotor Symptoms; Hot Flashes
Study of Erenumab (AMG 334) in Women With Hot Flashes
The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.
- Trial name
- NCT01890109
- Testing
- Erenumab
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- Amgen
Hot Flashes, Menopause
MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition.
- Conditions
- Hot Flashes, Menopause, Vasomotor Disturbance, Sleep
- Trial name
- MsFLASH-04 (NCT01936441)
- Testing
- Cognitive Behavioral Therapy-Insomnia (CBT-I), Menopause Education Control (MEC)
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
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
Vasomotor Symptoms
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period.
- Trial name
- Daylight (NCT05033886)
- Testing
- fezolinetant
- Where
- 69 sites in Belgium, Canada and 14 more
- Volunteers
- 453 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body
Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure.
- Trial name
- NCT04845841
- Testing
- Elinzanetant (BAY3427080) treatment A, Elinzanetant (BAY3427080) treatment B
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bayer
Obesity, Menopause Hot Flashes
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
- Trial name
- NCT07218445
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Hot Flashes, Sleep
LINE-1 and Alu Methylation Levels Among Middle Aged Women With Low Cardiovascular Risk Profile in Respect of Menopausal Hot Flashes
Vasomotor symptoms are the most common symptoms seen during climacterium. The hypoestrogenic state causes dysfunction of hypothalamic preoptic area, a thermoregulatory center.
- Conditions
- Hot Flashes, Sleep, Menopause, Cardiovascular Diseases
- Trial name
- NCT05892211
- Testing
- Polysomnography, Skin conductance, ALU and LINE-1 DNA methylation analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Women in the Menopausal Period
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
This randomized, parallel-group study will examine how artificial light exposure during nighttime awakenings affects sleep and brain health in midlife women experiencing vasomotor symptoms, such as hot flashes and night sweats.
- Trial name
- NCT07834944
- Testing
- Artificial Light at Night (ALAN) 100 lux, Artificial Light at Night (ALAN) Dim Light
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Hot Flashes
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice
This study is for women in Canada who are in menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS).
- Trial name
- CANDLELIGHT (NCT07602530)
- Testing
- Fezolinetant
- Where
- 2 sites in Canada
- Volunteers
- 238 people
- Sponsor
- Astellas Pharma Europe Ltd.
Postmenopausal Women With Moderate Vasomotor Symptoms
Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate…
- Trial name
- TRYSEM (NCT01116310)
- Testing
- Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
- Where
- 20 sites in Spain
- Volunteers
- 166 people
- Sponsor
- Laboratorios Casen-Fleet S.L.U.
Acute Coronary Syndrome, ST Segment Elevation Myocardial Infarction
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years.
- Conditions
- Acute Coronary Syndrome, ST Segment Elevation Myocardial Infarction, Stent
- Trial name
- MAGSTEMI (NCT03234348)
- Testing
- Percutaneous coronary intervention
- Where
- 11 sites in Spain
- Volunteers
- 151 people
- Sponsor
- Hospital Clinic of Barcelona
Hot Flashes
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause.
- Trial name
- OPTION-VMS (NCT06049797)
- Testing
- Fezolinetant, Paroxetine, Citalopram
- Where
- 48 sites in United States
- Volunteers
- 999 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause
Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes.
- Trial name
- Starlight 2 (NCT06206408)
- Testing
- Fezolinetant
- Where
- 64 sites in Japan
- Volunteers
- 410 people
- Sponsor
- Astellas Pharma Inc
Vasomotor Symptoms
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause
The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with…
- Trial name
- NCT00421031
- Testing
- DVS-233 SR
- Where
- 41 sites in United States
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hot Flushes, Vasomotor Symptoms
A Study of MF101 in Postmenopausal Women
This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.
- Trial name
- HERBA (NCT00906308)
- Testing
- MF101 5 g/day, MF101 10 g/day
- Where
- 50 sites in United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Bionovo