Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

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

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

Sponsors & Collaborators

• Solvay Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• United States
• Canada
• Russia

Study Locations