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: Randomized phase III trial to study the effectiveness of low-dose testosterone in improving libido in postmenopausal cancer survivors.

Condition	Treatment or Intervention	Phase
sexual dysfunction and infertility unspecified adult solid tumor, protocol specific sexuality and reproductive issues	Drug: testosterone  Procedure: androgen therapy  Procedure: complications of therapy assessment/management  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

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

Genders Eligible for Study:  Both

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

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/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: 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

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States
Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States

Study chairs or principal investigators

Charles L. Loprinzi, MD,  Mayo Clinic Cancer Center   
Debra Barton, RN, PhD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000349426; NCCTG-N02C3; NCT00075855
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075855
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08