NCT00272935

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Cenestin 0.3 mg Tablets	1 tablet daily
OTHER	Placebo	1 tablet daily

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-01-09
• Last updated: 2012-07-03

Locations

49 sites across 1 country: United States