Status:
COMPLETED
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
Lead Sponsor:
Duramed Research
Conditions:
Hot Flashes
Eligibility:
FEMALE
30-80 years
Phase:
PHASE3
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 flashe...
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
Eligibility Criteria
Inclusion
- 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
- Any contraindication to natural or synthetic estrogens
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00272935
Start Date
December 1 2005
End Date
May 1 2007
Last Update
July 3 2012
Active Locations (49)
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1
Duramed Investigational Site
Huntsville, Alabama, United States, 35801
2
Duramed Investigational Site
Montgomery, Alabama, United States, 36116
3
Duramed Investigational Site
Phoenix, Arizona, United States, 85013
4
Duramed Investigational Site
Phoenix, Arizona, United States, 85032