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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Sexuality and Reproductive Issues; Sexual Dysfunction; Cancer Survivor

Treatments: Other: placebo; Drug: therapeutic testosterone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00075855

CDR0000349426 (Registry Identifier)

NCI-2012-02568 (Registry Identifier)

NCCTG-N02C3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

testosterone

Experimental group

Description:

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.

Treatment:

Drug: therapeutic testosterone

placebo

Other group

Description:

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.

Treatment:

Other: placebo