Oakland, California 94612

  • Hot Flashes

Purpose:

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women


Study summary:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.


Criteria:

Inclusion Criteria: - Menopause - Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days) Exclusion Criteria: - Hormonal treatment - Contraindication to estrogen/progestogen therapy


Study is Available At:


Original ID:

91429


NCT ID:

NCT00206622


Secondary ID:

308261


Study Acronym:


Brief Title:

Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes


Official Title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determ


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

425


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:December 2004
Completion Date:February 2006
Completion Type:Actual
Verification Date:May 2009
Last Changed Date:May 28, 2009
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Other symptoms related to menopause
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Lowest effective dose in decreasing the frequency and severity of hot flushes
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Climara PRO (Estradiol / Levonorgestrel transder
Description:2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Arm Name:Arm 1
Intervention Type:Drug
Name:Menostar (Estradiol transdermal)
Description:1mg 17 Beta-estradiol transdermal patch
Arm Name:Arm 2
Intervention Type:Drug
Name:Placebo transdermal
Description:Placebo
Arm Name:Arm 3

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm 1
Study Arm Type:Active Comparator
Arm Name:Arm 2
Study Arm Type:Placebo Comparator
Arm Name:Arm 3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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