Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00446199 |
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 |
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
|
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
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 |
Health Authority: | United States: Food and Drug Administration |
Vasomotor symptom relief Postmenopausal women Severe to Moderate Vasomotor symptoms |
Signs and Symptoms Estradiol 3-benzoate Estradiol valerate Drospirenone |
Hot Flashes Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |