Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

Completed · Phase 2 · Has a placebo group

Conditions studied: Hot Flushes, Menopause, Postmenopause

In brief

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

Key facts

Study ID

NCT00160342

Run by

Solvay Pharmaceuticals

People needed

1251

Starts

2005-06-01

Expected to finish

2007-09-01

Last updated by the study team

2008-08-15

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
• Be a female of any race between the ages of 45-65 years, in generally good health,
• Be either naturally or surgically postmenopausal (with or without a uterus)

You may not qualify if…

• Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
• 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

Where it is running

• Site 69 — Montgomery, Alabama, United States
• Site 44 — Tucson, Arizona, United States
• Site 6 — Jonesboro, Arkansas, United States
• Site 62 — Little Rock, Arkansas, United States
• Site 70 — Carmichael, California, United States
• Site 85 — Carmichael, California, United States
• Site 87 — Northridge, California, United States
• Site 18 — San Diego, California, United States
• Site 27 — San Diego, California, United States
• Site 54 — San Diego, California, United States
• Site 31 — Vista, California, United States
• Site 68 — Walnut Creek, California, United States
• Site 66 — Denver, Colorado, United States
• Site 4 — Groton, Connecticut, United States
• Site 35 — New Britain, Connecticut, United States
• Site 14 — Waterbury, Connecticut, United States
• Site 25 — Aventura, Florida, United States
• Site 26 — Aventura, Florida, United States
• Site 51 — Clearwater, Florida, United States
• Site 71 — Clearwater, Florida, United States
• Site 61 — Daytona Beach, Florida, United States
• Site 75 — Gainesville, Florida, United States
• Site 33 — Pensacola, Florida, United States
• Site 21 — Stuart, Florida, United States
• Site 37 — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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