Trial | NCT01370798  Report issue

Title

Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications
Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    promestriene ...

  • Study Participants

    244
Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.

A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.

The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.
Study Started
May 26
2011
Primary Completion
Sep 18
2017
Study Completion
Sep 18
2017
Last Update
Jul 12
2018

Drug promestriene

Promestriene cream 1%, 1g per day during 2 months, cutaneous application

Drug Placebo

Placebo of promestriene cream, 1g per day during 2 months, cutaneous application

Procedure Urethroplasty

Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability)

Radiation Wrist X ray

Wrist X ray to follow the degree of bone maturation

Procedure Blood test

Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH

promestriene Experimental

Children with severe hypospadias treated with promestriene 1%

Placebo Placebo Comparator

Control group, children with severe hypospadias treated with Placebo.

Criteria 

Inclusion Criteria:

Severe hypospadias with a division of the corpus spongiosum behind the midshaft of the penis and for which repair requires a urethral substitution by onlay urethroplasty.
Subjects operated between 9 and 36 months old.
Subjects operated in one of the departments of paediatric urology involved in the study.
Surgery performed by a surgeon with at least 5 years of practical experience in the hypospadias surgery.
Written informed consent obtained from parents or legal guardians prior to the participation to the study
All hypospadias aetiology (hormonal, karyotype or genetic)

Exclusion Criteria:

Refusal to participate
Subjects with glandular hypospadias
Subjects aged <9 months or > 36months old at time of surgery.
Subjects who had prior surgery of penis (circumcision or hypospadias surgery)
Subjects treated with androgens (Human Chorionic Gonadotrophin or delayed testosterone) within 6 months prior to surgery.
Intolerance to promestriene or its excipients.
Not affiliated to a healthy or social security cover.
Known tumoral risk
Pure or mixed gonadal dysgenesis (45, X0/46,XY)
No Results Posted