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Estrogen cream may cut surgery complications in boys with birth defect

NCT ID NCT01370798

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether applying estrogen cream to the penis for two months before surgery reduces complications in boys with severe hypospadias, a birth defect where the urethra opening is not at the tip. 244 boys aged 9-36 months received either estrogen cream or a placebo cream daily before undergoing urethroplasty. The goal was to see if estrogen improves healing and lowers the risk of fistulas or wound breakdown after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
promestriene (estrogen) cream
What this could lead to
If it works, this could reduce the need for repeat surgeries in boys with severe hypospadias.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all cases. Estrogen cream may cause local irritation or hormonal effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

244 people

The number who actually took part.

Started

May 2011

Finished

Sep 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 to 36 months

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

hypospadias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypospadias

Contacts and locations

Locations

  • Hôpital Mère-Enfant

    Nantes, 44093, France

  • Hôpital NECKER

    Paris, 75015, France

  • Hôpital Robert Debré

    Paris, 72015, France

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

    Bron, 69677, France

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