TDSM- Testosterone Dose Response in Surgically Menopausal Women
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
TDSM will study the physiology of testosterone in women ages 21-60 who have had surgical
menopause (uterus and both ovaries removed). Testosterone is commonly thought of as a "male
hormone" thus being that it is the male's primary hormone. Women produce testosterone in much
smaller amounts and despite this, testosterone still plays a significant role. Fifty percent
of a women's testosterone is made in her adrenal glands (glands that sit on top of the
kidneys) and fifty percent is made in her ovaries. When a woman has her ovaries removed it is
thought that her testosterone levels decrease rapidly and significantly. This study will be
examining testosterone's role in sexual function, general well being, muscle performance,
cognitive function, carbohydrate metabolism and muscle and fat distribution.
The study is 14 months long with weekly to monthly visits. The subjects will be placed on the
estrogen patch for the duration of the study. They will also be given weekly injections of
testosterone or placebo for 6 months. During the testosterone treatment phase the women will
be separated into 5 groups. The groups include a dose of testosterone that is very low, low,
medium, high and placebo. A placebo looks and feels similar to testosterone; however it does
not have testosterone in it. We use this to test if the subject is having a response to the
testosterone itself or the thought of receiving testosterone. Neither the subject nor the
investigators will know the dose until the end of the study.
Phase:
N/A
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)