A Phase 2/3 interventional study of Testosterone undecanoate and Castor Oil in Klinefelter Syndrome, Hypergonadotropic Hypogonadism and Hypergonadotropic Azospermia, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by University of Roma La Sapienza · Phase 2/3, Interventional, and Treatment
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.
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.
47 studies on the registry are indexed under Klinefelter Syndrome; 17 are open to participants now.
This study's enrollment of 56 is above the median of 44 across 19 interventional studies indexed under Klinefelter Syndrome.
Browse Klinefelter Syndrome studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Testosterone undecanoate 1000mg injection at baseline (0-week), 6-week, 18-week, 30-week
Drug: Testosterone undecanoate
Injection 4 ml of castor oil at baseline (week-0), week-6, week-18, week-30
Drug: Castor Oil
Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week
Also known as: Nebido
4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.
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).
Time frame: 4 month
Nodule Size
Percentage change in the area of the lesion (measured with computer assisted graphics).
Time frame: 4 month
Luteinizing Hormone (LH)
Reduction of the serum Luteinizing Hormone (LH) levels during testosterone therapy
Time frame: 2 month
Spermatogenesis
Evaluation of sperm cell production after testosterone withdrawal.
Time frame: 8 month (follow-up)
Testicular US echo-texture
Changes in the number of areas / nodules / lesions in the long-term safety assessment
Time frame: 36 month (follow-up)
The record gives a start of Jun 2009, a primary completion of Jun 2017 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
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