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

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 4


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 cypionate Levonorgestrel Estradiol valerate Estradiol acetate Estradiol hemihydrate

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 (Adult, Senior)
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

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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

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

ClinicalTrials.gov processed this record on September 23, 2016