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

NCT01370798 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-09-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Pierre Mouriquand, Prof · HOPITAL FEMME MERE ENFANT CHU DE LYON

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
36 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-26
Primary Completion
2017-09-18
Completion
2017-09-18

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01370798 on ClinicalTrials.gov