Clinical trial · Interventional
Short-term Testosterone Replacement in Testicular Cancer Survivors
Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study
NCT03339635CI-TRIAL-00079266completedPhase 2ClinicalTrials.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)
To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgel (Testosterone gel) | Drug | — | UNRESOLVED |
| Placebo gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Testosterone gel
- description
- Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
- interventionNames
- Drug: Androgel (Testosterone gel)
- type
- PLACEBO_COMPARATOR
- label
- Placebo gel
- description
- Patients will be randomized to treatment with placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
- interventionNames
- Drug: Androgel (Testosterone gel)
- Drug: Placebo gel
Primary outcomes (1)
- measure
- percent change in fat mass as measured using using full body dual X-ray absorptiometry
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * patients with metastatic testicular cancer after unilateral orchidectomy and chemotherapy, at least 12 months after completion of last treatment and without evidence of disease. Combination chemotherapy should have contained a platinum compound, either cisplatin or carboplatin. In TC survivors, testosterone levels are routinely measured in blood during follow-up once every two years. * Patients are eligible for screening if they are between 18 and 55 years of age * have a documented low or low-normal total testosterone level ≤14 nmol/L, as measured during any of the follow-up visits, irrespective of signs and symptoms of androgen deficiency. Eligible for actual study participation and randomization between Androgel and placebo will be: * survivors of TC not using testosterone supplements, having biochemical evidence of hypogonadism (defined as a serum total testosterone concentration ≤ 12 nmol/L (345 ng/dL) measured after an overnight fast between 8:00 and 10:00 AM), and being overweight (as defined by a BMI ≥ 25 and \<35 kg/m2). * Patients should be able to understand and abide to the study protocol and sign written informed consent. Exclusion Criteria: * patients with a history of extragonadal testicular cancer * patients planning to father children within the next 12 months * patients taking corticosteroids or hormone replacement other than testosterone within 3 months of randomization * patients taking medication with any antiandrogenic effects (e.g. spironolactone) * patients with signs or history of hormone-dependent cancer (prostate or breast cancer) * patients with severe lower urinary tract symptoms (as defined by International Prostate Symptom Score \>19) * patients with a history of coronary artery disease (angina pectoris, myocardial infarction) or heart failure * patients with hematocrit \>50% * patients with untreated severe obstructive sleep apnea * patients with uncontrolled hypertension * patients with a BMI \> 35 kg/m2 * patients with a history of epilepsy * patients with debilitating psychiatric illness or inability to understand the study protocol, according to the opinion of the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.