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

NCT01370798 | Completed Phase 3 DMC

• 2 other identifiers: 2010.6082010-023686-22
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Severe hypospadias; local oestrogen; promestriene; Onlay-tube-onlay urethroplasty; post-operative complications; fistula dehiscence

Outcome Measures

Primary Outcomes (1)

• Number of patient with postoperative urethral fistula and dehiscence

  1 year

Secondary Outcomes (6)

• Re-intervention related to wound healing

  1 year

• post-surgical complications

  1 year

• Re-intervention not related to wound healing

  1 year

• Hormone measurement

  2 months

• Bone age evaluation

  14 monthes

Study Arms (2)

promestriene

EXPERIMENTAL

Children with severe hypospadias treated with promestriene 1%

Drug: promestriene; Procedure: Urethroplasty; Radiation: Wrist X ray; Procedure: Blood test

Placebo

PLACEBO COMPARATOR

Control group, children with severe hypospadias treated with Placebo.

Drug: Placebo; Procedure: Urethroplasty; Radiation: Wrist X ray; Procedure: Blood test

Interventions

promestriene DRUG

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

promestriene

Placebo DRUG

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

Placebo

Urethroplasty PROCEDURE

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

Placebo; promestriene

Wrist X ray RADIATION

Wrist X ray to follow the degree of bone maturation

Placebo; promestriene

Blood test PROCEDURE

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

Placebo; promestriene

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant

Bron, 69677, France

Location

Hôpital Mère-Enfant

Nantes, 44093, France

Location

Hôpital Robert Debré

Paris, 72015, France

Location

Hôpital NECKER

Paris, 75015, France

Location

Related Publications (1)

• Gorduza D, Plotton I, Remontet L, Gay CL, El Jani M, Cheikhelard A, Blanc T, El Ghoneimi A, Leclair MD, Roy P, Pirot F, Mimouni Y, Gaillard S, Chatelain P, Morel Y, Kassai B, Mouriquand P. Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa231. doi: 10.1210/clinem/dgaa231.

  PMID: 32386308 RESULT

MeSH Terms

Conditions

Hypospadias

Interventions

promestriene; Hematologic Tests

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Pierre Mouriquand, Prof

  HOPITAL FEMME MERE ENFANT CHU DE LYON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: May 26, 2011
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (4)