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

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 Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206622

Enrollment

425

Registered

2005-09-21

Start date

2004-12-31

Completion date

2006-02-28

Last updated

2009-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Brief summary

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

Detailed description

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.

Interventions

DRUGClimara PRO (Estradiol / Levonorgestrel transdermal)

2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch

DRUGMenostar (Estradiol transdermal)

1mg 17 Beta-estradiol transdermal patch

DRUGPlacebo transdermal

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lowest effective dose in decreasing the frequency and severity of hot flushes	—

Secondary

Measure	Time frame
Other symptoms related to menopause	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026