NCT00160342

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,251 (estimated)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Conditions

• Hot Flushes, Menopause, Postmenopause

Interventions

Type	Name	Description
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.30 EE
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.45 EE
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, 0.60 MT
DRUG	Esterified Estrogens (EE) and Methyltestosterone (MT)	oral tablet, QD, 12 weeks, Placebo

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-09-12
• Last updated: 2008-08-15

Locations

125 sites across 3 countries: United States, Canada, Russia