Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075855
• Other study ID #: NCCTG-N02C3
• Secondary ID: NCI-2012-02568CD
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2004
• Last updated: July 12, 2016
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

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:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer Survivor
• Sexual Dysfunction
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• therapeutic testosterone

Other:
• placebo

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Medcenter One Health System	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. doi: 10.1093/jnci/djn311. Epub 2008 Oct 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mood		Up to 6 months	Yes
Secondary	quality of life		Up to 6 months	No
Secondary	overall vitality		Up to 6 months	No