Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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 changes to the vaginal anatomy

• Prior hysterectomy allowed

Other

• Concurrent antidepressants for postmenopausal mood or hot flashes allowed provided patient is on a stable dose that will not change within the next 8 weeks

• No concurrent anticoagulants or propanolol

• Concurrent anticoagulants for central or peripheral line maintenance (e.g., warfarin 1 mg daily or heparin flushes) allowed

• No other concurrent treatment for decreased libido