Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed Postmenopausal NCI NCCTG-N02C3 NCT00075855

Objectives

Primary

1. 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

1. Determine the toxic effects of this drug in these patients.
2. Determine the levels of estrogen and testosterone and SGOT in patients reporting a decreased libido before and after treatment with this drug.
3. Determine whether increasing libido significantly positively affects pleasure from sexual activity in patients treated with this drug.
4. Determine the effect of this drug on vitality, general quality of life, and overall mood in these patients.

Entry 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



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

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

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

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 2,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

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.

Barton DL, Wender DB, Sloan JA, et al.: Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3. J Natl Cancer Inst 99 (9): 672-9, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol co-chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu
Debra Barton, RN, PhD, Protocol chair		Ph: 507-284-2511

Registry Information
Official Title		The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
Trial Start Date		2004-04-23
Registered in ClinicalTrials.gov		NCT00075855
Date Submitted to PDQ		2003-12-09
Information Last Verified		2005-02-10