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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hot Flashes

In brief

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.

Key facts

Study ID

NCT00272935

Run by

Duramed Research

People needed

400

Starts

2005-12-01

Expected to finish

2007-05-01

Last updated by the study team

2012-07-03

Who can join

Age: 30 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any contraindication to natural or synthetic estrogens

Where it is running

• Duramed Investigational Site — Huntsville, Alabama, United States
• Duramed Investigational Site — Montgomery, Alabama, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Phoenix, Arizona, United States
• Duramed Investigational Site — Tucson, Arizona, United States
• Duramed Investigational Site — Carmichael, California, United States
• Duramed Investigational Site — Irvine, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — San Ramon, California, United States
• Duramed Investigational Site — Brooksville, Florida, United States
• Duramed Investigational Site — Coral Gables, Florida, United States
• Duramed Investigational Site — Gainesville, Florida, United States
• Duramed Investigational Site — Leesburg, Florida, United States
• Duramed Investigational Site — Miami, Florida, United States
• Duramed Investigational Site — Palm Springs, Florida, United States
• Duramed Investigational Site — Venice, Florida, United States
• Duramed Investigational Site — Alpharetta, Georgia, United States
• Duramed Investigational Site — Douglasville, Georgia, United States
• Duramed Investigational Site — Boise, Idaho, United States
• Duramed Investigational Site — Evansville, Indiana, United States
• Duramed Investigational Site — Lexington, Kentucky, United States
• Duramed Investigational Site — Baltimore, Maryland, United States
• Duramed Investigational Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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