Hot Flashes Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
The primary objective of this study was to determine the clinical safety of RAD1901 and to evaluate whether RAD1901 reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS; "hot flashes") in postmenopausal women.
This was a Phase 2b outpatient, prospective, multicenter, double-blind, randomized,
placebo-controlled study to determine whether elacestrant reduces the frequency and severity
of vasomotor symptoms (VMS; "hot flashes") in postmenopausal women with moderate to severe
hot flashes. Postmenopausal women who met study criteria were followed for 12 weeks on
double-blind study medication and two weeks off study medication.
Treatment was randomized 1:1:1:1 to ensure that an approximately equal number of patients
were exposed to each of three RAD1901 (elacestrant) doses (5, 10 and 20 mg/day) or placebo.
The total period of placebo exposure was 14 weeks.
Enrolling approximately 300 patients was expected to provide power for testing superiority of
the primary efficacy endpoint outcomes.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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N/A | |
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||
| Completed |
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|
Phase 1 | |
| Completed |
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Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
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Phase 2 | |
| Completed |
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Mechanical Device for the Relief of Hot Flashes
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Phase 2 | |
| Completed |
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Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
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Phase 2 | |
| Completed |
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Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
|
Phase 3 | |
| Completed |
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N/A | |
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| Completed |
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Phase 3 | |
| Completed |
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Phase 3 | |
| Terminated |
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N/A | |
| Completed |
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Effects of Black Cohosh on Menopausal Hot Flashes
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Phase 2 | |
| Active, not recruiting |
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Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
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N/A | |
| Recruiting |
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N/A | |
| Recruiting |
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| Recruiting |
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Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
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N/A | |
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|
N/A | |
| Completed |
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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 (OASIS-2)
|
Phase 3 | |
| Completed |
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Evaluation of SAMe for Hot Flashes
|
Phase 2 |