Clinical trial · Interventional
Low-Dose Testosterone in Improving Libido in Postmenopausal Female Cancer Survivors
The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
NCT00075855CI-TRIAL-00023018completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
| Sexuality and Reproductive Issues | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| therapeutic testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- testosterone
- 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.
- interventionNames
- Drug: therapeutic testosterone
- type
- OTHER
- label
- placebo
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDJones 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
- RESULTBarton 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