Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sexual Dysfunction and Infertility; Sexuality and Reproductive Issues; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: therapeutic testosterone (Drug); androgen therapy (Procedure); complications of therapy assessment/management (Procedure); endocrine therapy (Procedure); hormone therapy (Procedure); supportive care/therapy (Procedure)
Phase: Phase 3
Status: No longer recruiting
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Affiliation: Mayo Clinic
Debra Barton, RN, PhD, Study Chair, Affiliation: Mayo Clinic
Summary
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: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.
Clinical Details
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
Study design: Interventional, Supportive Care, Randomized, Double-Blind, Placebo Control
Detailed description:
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.
Eligibility
Gender(s): Female.
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
Locations and Contacts
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
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
April 2004
Last updated: March 5, 2007
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