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

Alliance for Clinical Trials in Oncology150 enrolled

Overview

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.

OBJECTIVES: Primary * Determine the efficacy of low-dose testosterone, in terms of average intra-patient change in libido, in postmenopausal female cancer survivors with a decreased libido. Secondary * Determine the toxic effects of this drug in these patients. * Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug. * Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug. * Determine the effect of this drug on vitality, general quality of life, and overall mood in these patients. OUTLINE: This is a double-blind, placebo-controlled, randomized, crossover, multicenter study. Patients are stratified according to antidepressant medication use (yes vs no), age (under 50 vs 50 to 60 vs 61 to 70 vs over 70), tamoxifen or other selective estrogen receptor modulator use (yes vs no), and ovarian status (in place \[natural menopause or hysterectomy\] vs not in place \[bilateral oophorectomy\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive topical testosterone once daily for 4 weeks. * Arm II: Patients receive a topical placebo once daily for 4 weeks. After 4 weeks, patients cross over to the other treatment arm. Changes in sexual functioning, mood states, and medical outcome vitality are assessed at baseline and then at the end of weeks 4 and 8. Patients who continue or restart testosterone cream after the 8-week study period are followed at 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cancer Survivor Sexual Dysfunction Sexuality and Reproductive Issues Unspecified Adult Solid Tumor, Protocol Specific

Interventions

therapeutic testosteroneDRUG

placeboOTHER

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (16)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Overall mood

Time frame: Up to 6 months

Secondary Outcomes

quality of life

Time frame: Up to 6 months

overall vitality

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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