A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

Phase 3

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Cenestin 0.3 mg Tablets; Other: Placebo

• Registration Number: NCT00272935
• Lead Sponsor: Duramed Research

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-09
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2009-07
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cenestin 0.3 mg Tablets	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change in average frequency of moderate to severe hot flashes	Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes	Baseline to Day 28 and to Day 84

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of Cenestin 0.3mg	Throughout study

Trial Locations

Locations (1)

Duramed Investigational Site; 🇺🇸 Tacoma, Washington, United States