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Androgen for Leydig Cell Proliferation

NCT01206270 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-09-25

No results posted yet for this study

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

Interventions

DRUG

Testosterone undecanoate

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

DRUG

Castor Oil

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

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Andrea Lenzi, MD · University of Roma La Sapienza

  • Andrea Isidori, MD, PhD · University of Roma La Sapienza

  • Vincenzo Bonifacio, MD, PhD · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206270 on ClinicalTrials.gov