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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

Phase 3
Not Enrolling
Cancer Survivor, Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- 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.


- 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.

PROJECTED ACCRUAL: A total of 140 patients (70 per treatment arm) will be accrued for this
study within 14 months.

Inclusion Criteria


- 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

- Hormone receptor status:

- Not specified



- See Menopausal status


- 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

Life expectancy

- Not specified


- WBC ≥ 2,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- No untreated anemia


- SGOT ≤ 1.5 times upper limit of normal (ULN)

- No known liver disease


- Creatinine ≤ 1.5 times ULN

- No renal dysfunction


- No coronary artery disease

- No congestive heart failure


- No untreated hypothyroidism

- No diabetes

- No major depressive disorder requiring treatment


Biologic therapy

- Not specified


- 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


- Concurrent radiotherapy allowed


- No prior major pelvic surgery resulting in anatomical changes to the vaginal anatomy

- Prior hysterectomy allowed


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Charles L. Loprinzi, MD

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • Unspecified Adult Solid Tumor, Protocol Specific
  • sexual dysfunction
  • unspecified adult solid tumor, protocol specific
  • sexuality and reproductive issues
  • cancer survivor
  • Sexual Dysfunctions, Psychological



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