Clinical trial · Interventional
Androgen for Leydig Cell Proliferation
Androgen Treatment in Leydig Cell Proliferation
- 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)
Patients with infertility often presents alterations at ultrasonographic examination of the testis. These alterations include a much higher incidence of small, multiple, non-palpable hypoechoic micro-nodules that can show internal vascularization. This finding often create alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.
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 |
|---|---|---|---|
| Hypergonadotropic Azospermia | — | UNRESOLVED | — |
| Hypergonadotropic Cryptozoospermia | — | UNRESOLVED | — |
| Hypergonadotropic Hypogonadism | — | UNRESOLVED | — |
| Klinefelter Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Castor Oil | Drug | — | UNRESOLVED |
| Testosterone undecanoate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Testosterone
- description
- Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week
- interventionNames
- Drug: Testosterone undecanoate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30
- interventionNames
- Drug: Castor Oil
Primary outcomes (1)
- measure
- Nodule Size per Number
- timeFrame
- 4 month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Non-palpable Multiple hypoechoic testicular nodules (with the largest having a diameter \> 2 mm and \< 12 mm) * Serum Follicle-stimulating hormone (FSH) \> 7 mIU/ml (m-International-Unit/ml) * Serum Luteinizing hormone (LH) \> 7 IU (International-Unit/ml) * Infertility: Klinefelter Syndrome, Hypergonadotropic Hypogonadism, Hypergonadotropic Azospermia, Hypergonadotropic Cryptozoospermia * negative testicular tumors markers: beta-hCG (Human chorionic gonadotropin), alpha-FP (alpha-Feto-Protein), CEA (Carcinoembryonic antigen), LDH (Lactate dehydrogenase), ferritin, PLAP (Placental Alkaline Phosphatase). Exclusion Criteria: * Hypogonadotropic Hypogonadism * FSH o LH \< 7 UI * non-homogeneous testicular lesion \> 12 mm * positive testicular tumors markers: beta-hCG, alpha-FP, CEA, LDH, ferritin, PLAP * patients with contraindication to testosterone therapy: prostate cancer, PSA\>4 ng/ml, severe hepatic or renal insufficiency, Hb\>17, Htc\>52%, severe urinary retention * desire to conceive * history of germ-cell testicular neoplasia
References
Publications (1)
- DERIVEDPozza C, Pofi R, Tenuta M, Tarsitano MG, Sbardella E, Fattorini G, Cantisani V, Lenzi A, Isidori AM, Gianfrilli D; TESTIS UNIT. Clinical presentation, management and follow-up of 83 patients with Leydig cell tumors of the testis: a prospective case-cohort study. Hum Reprod. 2019 Aug 1;34(8):1389-1403. doi: 10.1093/humrep/dez083. PMID 31532522