NCT01370798

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Male
• Age: 9 Months – 36 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypospadias

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-26
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2011-06-10
• Last updated: 2025-09-04

Locations

4 sites across 1 country: France