Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075855

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: therapeutic testosterone	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2004

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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075855

Locations

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

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Investigator:	Charles L. Loprinzi, MD	Mayo Clinic
Study Chair:	Debra Barton, RN, PhD, AOCN	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Barton DL, Wender DB, Sloan JA, Dalton RJ, Balcueva EP, Atherton PJ, Bernath AM Jr, DeKrey WL, Larson T, Bearden JD 3rd, Carpenter PC, Loprinzi CL. 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. 2007 May 2;99(9):672-9.

Jones B, Haughie S. Re: 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. 2008 Oct 15;100(20):1482; author reply 1482. Epub 2008 Oct 7. No abstract available.

Study ID Numbers:	CDR0000349426, NCCTG-N02C3
Study First Received:	January 9, 2004
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00075855 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

sexual dysfunction and infertility
unspecified adult solid tumor, protocol specific
sexuality and reproductive issues
cancer survivor

Study placed in the following topic categories:

Infertility
Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Androgens
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Androgens
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on May 06, 2009