NCT01206270|CompletedPhase 2/3DMC
Androgen for Leydig Cell Proliferation
ALCeP
Androgen Treatment in Leydig Cell Proliferation
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Sponsor study identifier
interventional
56
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2017
Actual (reported)Study Completion
June 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 9, 2010
Actual (reported)September 21, 2010
Actual (reported)June 2017
Actual (reported)June 2018
Actual (reported)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
Nodule Size
4 month
Luteinizing Hormone (LH)
2 month
Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week
Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30
Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week
4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.
Dipartimento di Fisiopatologia Medica
Rome, Lazio, 00161, Italy
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.
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
56 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2010
First Posted
September 21, 2010
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction
Spermatogenesis
8 month (follow-up)
Testicular US echo-texture
36 month (follow-up)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2017
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
September 25, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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