Low-Dose Hormone Therapy for Relief of Vasomotor Symptoms - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00446199

Purpose

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Condition	Intervention	Phase
Vasomotor Symptoms Hot Flashes	Drug: SH T546P Drug: SH T04739CA and SH T04739BA Drug: SH T04739DA	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Mean change from baseline to Week 12 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 12 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly frequency of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Mean change from baseline to Week 4 in weekly mean daily severity of moderate to severe hot flushes [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from baseline to Week 12 in vaginal pH and vaginal maturation index [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]
Symptoms of vulvar and vaginal atrophy and urogenital symptoms at baseline and Week 12 [ Time Frame: After 4- and 12-week treatment phase ] [ Designated as safety issue: No ]

Enrollment:	910
Study Start Date:	March 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Placebo Comparator	Drug: SH T546P Matching placebo tablet
Arm 2: Experimental	Drug: SH T04739CA and SH T04739BA Drospirenone/E2- Both make up the Active Study Medication Tablet which is Drospirenone/17B-estradiol
Arm 3: Experimental	Drug: SH T04739CA and SH T04739BA Drospirenone/E2- Both make up the Active Study Medication Tablet which is Drospirenone/17B-estradiol
Arm 4: Experimental	Drug: SH T04739DA 17B-estradiol - Active Study Medication Tablet

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:

Postmenopausal women > 40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

The usual exclusion criteria for hormone therapy apply.
Intake of medications other than hormones affecting hot flushes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446199

Show 75 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

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No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91493, 310184
Study First Received:	March 9, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00446199 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Vasomotor symptom relief
Postmenopausal women
Severe to Moderate Vasomotor symptoms

Additional relevant MeSH terms:

Signs and Symptoms
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Drospirenone
Hot Flashes
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009