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Sponsored by: |
Duramed Research |
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Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00272935 |
This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Hot Flashes |
Drug: Cenestin 0.3 mg Tablets Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women |
Estimated Enrollment: | 400 |
Study Start Date: | December 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cenestin 0.3 mg Tablets
1 tablet daily
|
2: Placebo Comparator |
Other: Placebo
1 tablet daily
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The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Duramed Research Protocol Chair | Duramed Research, Inc |
Responsible Party: | Duramed Research, Inc. ( Duramed Protocol Chair ) |
Study ID Numbers: | BR-CEN-301 |
Study First Received: | January 4, 2006 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00272935 |
Health Authority: | United States: Food and Drug Administration |
menopause vasomotor symptoms |
Signs and Symptoms Estrogens, conjugated synthetic A Estrogens, Conjugated (USP) Hot Flashes Menopause |
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |