Clinical trial NCT00075855: Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Survivor
Sexual Dysfunction
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: sexual dysfunction
unspecified adult solid tumor, protocol specific
sexuality and reproductive issues
cancer survivor
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-01-13
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

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

Primary outcomes:
measure: Overall mood
timeFrame: Up to 6 months
Secondary outcomes:
measure: quality of life
timeFrame: Up to 6 months
measure: overall vitality
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Mayo Clinic Scottsdale Oncology Program
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Omaha
country: United States
facility: CCOP - Missouri Valley Cancer Consortium
state: Nebraska
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Danville
country: United States
facility: CCOP - Geisinger Clinic and Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Charles L. Loprinzi, MD
References:
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. No abstract available.
citation: 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. doi: 10.1093/jnci/djk149.