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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00075855

Collaborator

National Cancer Institute (NCI) (NIH)

150

Enrollment

Locations

Arms

Duration (Months)

9.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivor Sexual Dysfunction Sexuality and Reproductive Issues Unspecified Adult Solid Tumor, Protocol Specific	Drug: therapeutic testosterone Other: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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 Start Date :

Apr 1, 2004

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: testosterone Patients receive topical testosterone 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.	Drug: therapeutic testosterone
Other: placebo 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.	Other: placebo

Arm

Intervention/Treatment

Experimental: testosterone

Patients receive topical testosterone 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.

Drug: therapeutic testosterone

Other: placebo

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.

Other: placebo

Outcome Measures

Primary Outcome Measures

Overall mood [Up to 6 months]

Secondary Outcome Measures

quality of life [Up to 6 months]
overall vitality [Up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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