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Status:

COMPLETED

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

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Cancer Survivor

Sexual Dysfunction

Eligibility:

FEMALE

Phase:

PHASE3

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 ra...

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. Seconda...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT00075855

    Start Date

    April 1 2004

    End Date

    October 1 2007

    Last Update

    July 13 2016

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    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