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About
The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.
Full description
Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health. Among its likely actions in women are the building of bone and muscle mass, increase in interest in sex (libido) and effects on the mood. Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production. Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches. It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Women age 18-55
Hypopituitarism with central adrenal and/or gonadal deficiencies. To qualify patients will need to have either 1 or 2 and they need to have 3:
No other significant medical condition
Weight between 80 and 150% of ideal body weight
Able to provide informed consent
All races and ethnicities
All patients regardless of marital status and relationship status.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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