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NCT00185237 Clinical Trial

Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

Hot Flashes Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00185237
Other study ID # 91441
Secondary ID 309120
Status Completed
Phase Phase 3
First received September 9, 2005
Last updated December 22, 2014
Start date July 2005
Est. completion date November 2006

Study information
Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences AuthorityHong Kong: Department of HealthMalaysia: Ministry of HealthThailand: Food and Drug AdministrationPhilippines: Bureau of Food and Drugs
Study type Interventional

Clinical Trial Summary

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

- Evidence of postmenopausal status

Exclusion Criteria:

- Contraindication to estrogen therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Menostar (estradiol transdermal delivery system)
Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)
• Placebo
Placebo patch

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Outcome
Type Measure Description Time frame Safety issue
Primary Relative change in frequency of hot flushes 12 weeks No
Secondary Change in intensity of hot flushes 12 weeks No
Secondary Changes in vaginal pH 12 weeks No
Secondary Changes in vaginal maturation index 12 weeks No
Secondary Occurrence of urogenital symptoms 12 weeks No
Secondary Change in MENQOL (menopausal quality of life questionaire) 12 weeks No
Secondary Bleeding profile 12 weeks No
Secondary Safety 12 weeks Yes
See also
  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

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