Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors (NCT00075855) | Clinical Trial Compass
CompletedPhase 3
Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
United States150 participantsStarted 2004-04
Plain-language summary
RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not yet known whether testosterone is effective in improving libido in female cancer survivors.
PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.
Who can participate
SexFEMALE
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DISEASE CHARACTERISTICS:
* History of cancer
* No active disease
* Currently has a sexual partner
* Reports a decrease in sexual desire or libido and would like an intervention for it
* Defined as a score of less than 8 on the numerical analogue scale
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex
* Female
Menopausal status
* Postmenopausal, defined as the following:
* Surgically induced menopause OR absence of a period for at least 12 months (naturally or treatment-induced)
Performance status
* ECOG 0-1
Hematopoietic
* WBC ≥ 2,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* No untreated anemia
Hepatic
* SGOT ≤ 1.5 times upper limit of normal (ULN)
* No known liver disease
Renal
* Creatinine ≤ 1.5 times ULN
* No renal dysfunction
Cardiovascular
* No coronary artery disease
* No congestive heart failure
Other
* No untreated hypothyroidism
* No diabetes
* No major depressive disorder requiring treatment
PRIOR CONCURRENT THERAPY:
Chemotherapy
* Concurrent cytotoxic chemotherapy (e.g., tamoxifen or aromatase inhibitors) allowed
Endocrine therapy
* No prior testosterone
* No prior androgen agents for libido
* Concurrent selective estrogen receptor modulators allowed
* Concurrent vaginal estrogen allowed provided it was initiated ≥ 1 month ago and continued at the same dose during study participation
Radiotherapy
* Concurrent radiotherapy allowed
Surgery
* No prior major pelvic surgery resulting in anatomical chang…