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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206622

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

Condition	Intervention	Phase
Hot Flushes	Drug: 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch and a 1mg 17 Beta-estradiol transdermal patch	Phase IV

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Determine the Lowest Effective Dose of Estradiol for the Relief of Moderate to Severe Hot Flushes

Further study details as provided by Bayer:

Primary Outcome Measures:

Lowest effective dose in decreasing the frequency and severity of hot flushes

Secondary Outcome Measures:

Other symptoms related to menopause

Study Start Date:

December 2004

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206622

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Berlex, Inc. Medical Affairs

1-888-BERLEX4

More Information

Publications indexed to this study:

Bachmann GA, Schaefers M, Uddin A, Utian WH. Lowest effective transdermal 17beta-estradiol dose for relief of hot flushes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Oct;110(4):771-9.

Study ID Numbers:	308261
Study First Received:	September 12, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00206622
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Benzoates
Levonorgestrel
Estradiol 3-benzoate
Estradiol valerate

Hot Flashes
Flushing
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female

Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009