Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors - Article
Clinical Trial: Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
This study is no longer recruiting patients.
|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 |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
- 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.
Genders Eligible for Study: Both
- 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
- Postmenopausal, defined as the following:
- Surgically induced menopause OR absence of a period for at least 12 months (naturally or treatment-induced)
- ECOG 0-1
- 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
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
- 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
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States
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
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States
Medcenter One Health System, Bismarck, North Dakota, 58501-5505, United States
CCOP - Dayton, Dayton, Ohio, 45429, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States
Charles L. Loprinzi, MD, Mayo Clinic Cancer Center
Debra Barton, RN, PhD, Study Chair, Mayo Clinic Cancer Center
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
Cache Date: April 9, 2005