Hot Flashes Clinical Trial
Official title:
Phase III, Multicenter, Double-Blind Study of the Safety and Efficacy of Bio-E-Gel (Topical Estradiol Gel) Versus Placebo for Treatment of Vasomotor Symptoms and Vulvovaginal Atrophy in Postmenopausal Females
The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.
Estrogens are a group of hormones that play an important role in normal sexual and
reproductive development in women. Estrogens serve many functions in the body. They
stimulate oocyte maturation and endometrial growth, decrease bone resorption, initiate the
development of secondary sex characteristics, maintain reproductive organs and glands, and
affect the activity of the central nervous system. At menopause, the decrease in estrogen
concentrations is often accompanied by vascular instability (hot flushes and night sweats),
a rise in the incidence of heart disease, and an increasing rate of bone loss. Estrogen is
available as an oral drug, a transdermal patch, or as a gel or lotion. Transdermal estrogen
is preferable as compared to oral, since it avoids the first-pass metabolism in the liver.
Since release of the WHI findings, current treatment recommendations are for the lowest
effective dose for the shortest period of time to treat postmenopausal symptoms.
Comparison: Three doses of a transdermal estradiol gel as compared to placebo for the
treatment of vasomotor and vulvovaginal atrophy symptoms in postmenopausal women.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04587154 -
Womens Study to Alleviate Vasomotor Symptoms
|
N/A | |
| Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
| Completed |
NCT05061563 -
A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults
|
Phase 1 | |
| Completed |
NCT05419908 -
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
|
Phase 2 | |
| Completed |
NCT01281332 -
Mechanical Device for the Relief of Hot Flashes
|
Phase 2 | |
| Completed |
NCT01439945 -
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
|
Phase 2 | |
| Completed |
NCT00755417 -
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT01293695 -
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
|
N/A | |
| Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A | |
| Completed |
NCT00256685 -
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause
|
Phase 3 | |
| Terminated |
NCT00244894 -
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
|
N/A | |
| Completed |
NCT00010712 -
Effects of Black Cohosh on Menopausal Hot Flashes
|
Phase 2 | |
| Active, not recruiting |
NCT03580499 -
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|
N/A | |
| Recruiting |
NCT06030388 -
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
|
N/A | |
| Recruiting |
NCT04418115 -
Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?
|
N/A | |
| Recruiting |
NCT04861701 -
Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise
|
N/A | |
| Active, not recruiting |
NCT05086705 -
EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer
|
N/A | |
| Completed |
NCT05099159 -
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 |
NCT01140646 -
Evaluation of SAMe for Hot Flashes
|
Phase 2 | |
| Completed |
NCT00956813 -
Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy
|
Phase 3 |