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

Condition(s) targeted: Hot Flashes

Intervention: Cenestin 0.3 mg Tablets (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Research Medical Monitor, Principal Investigator, Affiliation: Duramed Research

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Mean change in average frequency of moderate to severe hot flashes

Mean change in severity of moderate to severe hot flashes

Secondary outcome: Safety and tolerability of Cenestin 0.3mg

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

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Female.

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

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NIH - Postmenopausal Hormone Therapy

Starting date: December 2005
Ending date: May 2007
Last updated: February 29, 2008