NCT00272935CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Mean change in average frequency of moderate to severe hot flashes
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Naturally or surgically postmenopausal
- •At least 12 months since last menses or 6 weeks past surgery
- •Minimum of 7 daily or 50 weekly moderate to severe hot flashes
Exclusion Criteria
- •Any contraindication to natural or synthetic estrogens
Arms & Interventions
1
Experimental
Intervention: Cenestin 0.3 mg Tablets (Drug)
2
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Mean change in average frequency of moderate to severe hot flashes
Time Frame: Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Time Frame: Baseline to Day 28 and to Day 84
Secondary Outcomes
- Safety and tolerability of Cenestin 0.3mg(Throughout study)
Investigators
Study Sites (1)
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