Androgen for Leydig Cell Proliferation

NCT01206270 | Completed Phase 2 DMC

• 1 other identifier: 160/10
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Klinefelter Syndrome; Hypergonadotropic Hypogonadism; Hypergonadotropic Azospermia; Hypergonadotropic Cryptozoospermia

Keywords

Klinefelter; Leydig; Testicular Tumor; LH; Infertility

Outcome Measures

Primary Outcomes (1)

• Nodule Size per Number

  Percentage change of the area of the lesions multiplied by the number of the measured lesions: \[(area\_1 + area\_2 + area\_3 + ... + area\_n)\*n\]. The latter measure account for reduction in the number of lesions (disappearance).

  4 month

Secondary Outcomes (4)

• Nodule Size

  4 month

• Luteinizing Hormone (LH)

  2 month

• Spermatogenesis

  8 month (follow-up)

• Testicular US echo-texture

  36 month (follow-up)

Study Arms (2)

Testosterone

EXPERIMENTAL

Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week

Drug: Testosterone undecanoate

Placebo

PLACEBO COMPARATOR

Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30

Drug: Castor Oil

Interventions

Testosterone undecanoate DRUG

Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week

Also known as: Nebido

Testosterone

Castor Oil DRUG

4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Dipartimento di Fisiopatologia Medica

Rome, Lazio, 00161, Italy

Location

Related Publications (1)

• Pozza 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 DERIVED

MeSH Terms

Conditions

Klinefelter Syndrome; Hypogonadism; Testicular Neoplasms; Infertility

Interventions

testosterone undecanoate; Castor Oil

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Andrea Lenzi, MD

  University of Roma La Sapienza

  STUDY CHAIR

• Andrea Isidori, MD, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Vincenzo Bonifacio, MD, PhD

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 21, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

IT (1)