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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study

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

Intervention / Treatment
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* Drug: therapeutic testosterone
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: testosterone<br>Patients receive topical testosterone 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. | Drug: therapeutic testosterone<br> <br> |
| Other: placebo<br>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. | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mood |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | Up to 6 months | 
| overall vitality |  | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual dysfunction, unspecified adult solid tumor, protocol specific, sexuality and reproductive issues, cancer survivor