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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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
Active Comparator: Arm 1	Drug: Climara PRO (Estradiol / Levonorgestrel transdermal) 2.2mg 17 Beta-estradiol/0.69mg levonorgestrel combination transdermal patch
Active Comparator: Arm 2	Drug: Menostar (Estradiol transdermal) 1mg 17 Beta-estradiol transdermal patch
Placebo Comparator: Arm 3	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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:

Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 13, 2012