Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Estrogens; Estrogens, Esterified (USP); Estrone; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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