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 Flashes	Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) Drug: Menostar (Estradiol transdermal) Drug: Placebo transdermal	Phase IV

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

Resource links provided by NLM:

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

U.S. FDA Resources

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

Enrollment:	425
Study Start Date:	December 2004
Study Completion Date:	February 2006

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Arm 2: Active Comparator	Drug: Menostar (Estradiol transdermal) 1mg 17 Beta-estradiol transdermal patch
Arm 3: Placebo Comparator	Drug: Placebo transdermal Placebo

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
Accepts Healthy Volunteers:	No

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

Show 45 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91429, 308261
Study First Received:	September 12, 2005
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00206622 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Benzoates
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Hot Flashes
Hormones, Hormone Substitutes, and Hormone Antagonists

Estradiol 17 beta-cypionate
Hormones
Estradiol
Signs and Symptoms
Estradiol 3-benzoate
Levonorgestrel
Flushing
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hot Flashes
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate

Hormones
Estradiol
Pharmacologic Actions
Signs and Symptoms
Therapeutic Uses
Estradiol 3-benzoate
Levonorgestrel
Contraceptives, Oral, Synthetic
Polyestradiol phosphate

ClinicalTrials.gov processed this record on July 02, 2009