Dettagli per singolo studio

DEC-NET Serial number FR462

Published online	09/09/2005 12.05.00
Last updated	27/11/2006 12.22.59

Other protocol ID number	SFEDP/2002/01
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	Other disorders of male genital organs
Experimental drug
choriogonadotropine alfa Treatment regimen (dosage and duration) 1625 UI(either 62,5 mcg) of Ovitrelle is administrated by subcutaneous injection either 3 injections (J0-J3)in the clinical investigatation center or one injection (J6) in the child s residence.
Gender	Male
Age (range)	4 months- 12 years
Eligibility criteria
Inclusion criteria
1/Patients presenting one of the following criterias: -bilateral cryptorchidism (not palpated intra-abdominal testis or anorchia) -male pseudo-hermaphrodism (posterior or perineal penile hypospadias) -micropenis (<= 2,5 cm length). 2/Age: Minimum 4 months , Maximum 12 years and impubescens children (testosterone < 0.30 ng/ml) 3/Informed, written consent obtained from parent, guardian and/or patient as appropriate
Exclusion criteria
- Resticular ectopia with palpable testis - Penile hypospadias
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled
Purpose of study
1/Prinary objective: To define the methods of HCG test to evaluate bilateral cryptorchidism, micropenile and male pseudo-hermaphrodism, by comparing plasma testosterone increase after a single or after 3 injections of r-HCG. 2/Secondary objectives: -To compare the kinetics of secretion of delta 4 androstenedione and dihydrotestosterone(DHT)after 1 or 3 injections of r-HCG. -To compare r-HCG effect on the steroidogenesis with the u-HCG effects published in the literature. -To evaluate the results of HCG test(marker of Leydig cell function) with the basic rates of AMH and inhibin B (marker of Sertolie cell function).
Primary outcomes
Increase in plasma testosterone (expressed as a percentage) compared to the basal value.
Secondary outcomes
- kinetics of delta 4 androstenedione and the DHT - Sertoli cells function, - Testicular dysgenesis, - Abnormal steroïdogenic, - Oartial or complete insensitivity to androgens, - Hypophyseal failure, - Normality of testicular function.
Summary of study design, objectives, and ongoing research findings
Phase III, controlled, open, multicentric study aiming to define the way of using the HCG test for the evaluation of bilateral cryptorchidism, micropenis and male pseudo-hermaphrodism, by comparing testosterone rise after a single versus 3 injections of r-HCG.