Androgen for Leydig Cell Proliferation (ALCeP)
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|ClinicalTrials.gov Identifier: NCT01206270|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : September 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Klinefelter Syndrome Hypergonadotropic Hypogonadism Hypergonadotropic Azospermia Hypergonadotropic Cryptozoospermia||Drug: Testosterone undecanoate Drug: Castor Oil||Phase 2 Phase 3|
Patients with the testicular dysgenesis syndrome, that comprises a variable spectrum of clinical manifestations, such as infertility, cryptorchidism, hypospadias, impaired spermatogenesis and testicular germ cell neoplasms, often develop alterations in the Leydig cell compartment. These alterations range from abnormal localization and clustering to hyperplasia or tumorous formation.
Leydig cell tumors (LCTs), although uncommon in the general population, are the most frequent non-germ cell testicular neoplasms, and their incidence has been reported increasingly growing, especially in infertile patients. Given that the focal areas of Leydig cell hyperplasia are nowadays easily detectable at ultrasonography of the testis (US), as small non-palpable hypoechoic micro-nodules that can show internal vascularization, their finding create a diagnostic challenge versus low-stage malignant germ cell tumors.
Patients with testicular dysgenesis syndrome in general exhibit an elevation of Follicle-Stimulating Hormone (FSH), but in these patients, very frequently, even Luteinizing Hormone (LH) is above the reference range. The latter can work as a growth factor for Leydig cells. Since exogenous testosterone can suppress LH levels, it could be that androgen therapy could revert the LH-induced growth stimulation of Leydig cell compartment.
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.
The purpose of this study is also to evaluate whether the behavior (UltraSonographic appearance, US) of the non-palpable hypoechoic micro-nodules during a 4-month trial of testosterone therapy can offer a novel diagnostic tool in the differential diagnosis of benign versus malignant testicular nodules.
The trial will be open only for patients with multiple non-palpable hypoechoic micro-nodules that have an elevation of both FSH and LH and that are not seeking conception.
Participants in the study will be randomized to one of two treatment groups, receiving either testosterone undecanoate (low-dose androgen) or placebo, for two 6 months. All participants will be evaluated for safety at the beginning of the study and at 2, 4, and 6 months with careful history, physical examination, blood sampling and testicular ultrasonography. Patients will also be offered the possibility to perform Magnetic Resonance Imaging (MRI) of the testis at baseline and after treatment, and/or surgical enucleation of the lesions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Androgen Treatment in Leydig Cell Proliferation|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2018|
Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week
Drug: Testosterone undecanoate
Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week
Other Name: Nebido
Placebo Comparator: Placebo
Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30
Drug: Castor Oil
4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.
- Nodule Size per Number [ Time Frame: 4 month ]
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).
- Nodule Size [ Time Frame: 4 month ]Percentage change in the area of the lesion (measured with computer assisted graphics).
- Luteinizing Hormone (LH) [ Time Frame: 2 month ]Reduction of the serum Luteinizing Hormone (LH) levels during testosterone therapy
- Spermatogenesis [ Time Frame: 8 month (follow-up) ]Evaluation of sperm cell production after testosterone withdrawal.
- Testicular US echo-texture [ Time Frame: 36 month (follow-up) ]Changes in the number of areas / nodules / lesions in the long-term safety assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206270
|Dipartimento di Fisiopatologia Medica|
|Rome, Lazio, Italy, 00161|
|Study Chair:||Andrea Lenzi, MD||Sapienza University of Rome|
|Principal Investigator:||Andrea Isidori, MD, PhD||Sapienza University of Rome|
|Study Director:||Vincenzo Bonifacio, MD, PhD||Sapienza University of Rome|