The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
N/A
N/A
Female
Cancer Survivor, Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Charles L. Loprinzi, MD
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000349426
NCT ID:
NCT00075855
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
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
