Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

Completed · Phase 4 · Has a placebo group

Conditions studied: Hot Flashes

In brief

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

Key facts

Study ID

NCT00206622

Run by

Bayer

People needed

425

Starts

2004-12-01

Expected to finish

2006-02-01

Last updated by the study team

2009-05-29

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Menopause
• Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)

You may not qualify if…

• Hormonal treatment
• Contraindication to estrogen/progestogen therapy

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fair Oaks, California, United States
• Study site — Oakland, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — West Hartford, Connecticut, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Alpharetta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Champaign, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.