Estrogen cream may cut surgery complications in boys with birth defect

NCT ID NCT01370798

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

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.

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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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