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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Estrogens; Estrogens, Conjugated (USP); Estrogens, conjugated synthetic A

Criteria

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