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The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study


Phase 3
N/A
N/A
Not Enrolling
Female
Cancer Survivor, Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Charles L. Loprinzi, MD

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000349426

NCT ID:

NCT00075855

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • Unspecified Adult Solid Tumor, Protocol Specific
  • sexual dysfunction
  • unspecified adult solid tumor, protocol specific
  • sexuality and reproductive issues
  • cancer survivor
  • Sexual Dysfunctions, Psychological

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - DaytonKettering, Ohio  45429
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Medcenter One Health SystemBismarck, North Dakota  58501
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259