Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Condition(s) targeted: Hot Flushes, Menopause, Postmenopause

Intervention: Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug); Esterified Estrogens (EE) and Methyltestosterone (MT) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4

Mean change in frequency of moderate to severe VMS from baseline to Week 12

Mean change in severity of moderate to severe VMS from baseline to Week 4

Mean change in severity of moderate to severe VMS from baseline to Week 12

Secondary outcome:

Frequency and severity of moderate to severe and all hot flushes at each week

Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome

Mean change from baseline to Week 12 in vaginal pH

Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,

2. Be a female of any race between the ages of 45-65 years, in generally good health,

3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,

2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Site 124, Moscow, Russian Federation

Site 125, Moscow, Russian Federation

Site 126, Moscow, Russian Federation

Site 127, St. Petersburg, Russian Federation

Site 128, Moscow, Russian Federation

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Site 134, St. Petersburg, Russian Federation

Site 138, St. Petersburg, Russian Federation

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Starting date: June 2005
Ending date: September 2007
Last updated: February 12, 2008