Hot Flashes Clinical Trial
Official title:
Phase 3 Study of Applied Relaxation (AR) Technique That Treating Menopausal Symptoms
The purpose of this study is to demonstrate better efficacy and effectiveness of modified applied relaxation technique over its original version for treating menopausal symptoms.
Applied Relaxation (AR) is the most commonly used behavioral methods for treating menopausal
symptoms. Many clinical trials reported that the technique effectively improved vasomotor
and related symptoms. There is a strong evidence to support its continue use in clinical
settings.
However, the original AR technique is too cumbersome. It involves intensive training once a
week for 12 consecutive weeks. Each weekly session takes 60 minutes, and subjects are
requested to do self-practice at home for at least 15-20 minutes/day. As such, >25% of
recruited subjects drop out from the training course. The investigators have modified the
original AR technique by reducing the duration of training to only once, lasting 60 minutes.
Participants are requested to do self-practice at home for 15-20 minutes/day as in the
original technique. Instead of coming to a weekly class, the investigators use telephone to
communicate with the subjects once a week for 12 consecutive weeks. A preliminary study
showed all 10 recruited subjects remained in the study (MR; modified relaxation technique)
until completion. They all reported dramatic improvement in their vasomotor symptoms.
In this study, the investigators propose to compare our modified version of AR with the
original method in a randomized controlled clinical trial. The subjects will be Thai
menopausal women with vasomotor symptoms. The main outcomes are the reduction in the MRS
score (intensity of hot flushes, night sweats and sleep disturbances) among those who remain
in the program at the end of the study (efficacy evaluation). As nearly all patients will
remain in the MR group, while >25% of those in the AR group will be expected to drop out
from the study, the investigators should be able to demonstrate a superiority of MR over AR
in terms of effectiveness as well.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, 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 | |
| Completed |
NCT00391417 -
Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms
|
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 |