NCT00251082

Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Conditions

• Postmenopause

Interventions

Type	Name	Description
DRUG	continuous combined estradiol and dydrogesterone	0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
DRUG	continuous combined estradiol and dydrogesterone	1 Mg Estradiol and 5 Mg Dydrogesterone
DRUG	Placebo	Placebo

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-11-09
• Last updated: 2008-03-12

Locations

18 sites across 5 countries: Croatia, France, Poland, Romania, Russia