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

NCT00075855 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-N02C3NCI-2012-02568CDR0000349426
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall mood

  Up to 6 months

Secondary Outcomes (2)

• quality of life

  Up to 6 months

• overall vitality

  Up to 6 months

Study Arms (2)

testosterone

EXPERIMENTAL

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

placebo

OTHER

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

Interventions

therapeutic testosterone DRUG

testosterone

placebo OTHER

placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (2)

• 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.

  PMID: 18840823 BACKGROUND

• 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.

  PMID: 17470735 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Sexuality

Interventions

Testosterone Propionate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: April 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: October 1, 2007
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (16)