Skip to main content
OpenTrials
Completed

NCT Number: NCT01370798

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

9 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

promestriene

Drug

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

Placebo

Drug

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

Urethroplasty

Procedure

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

Wrist X ray

Radiation

Wrist X ray to follow the degree of bone maturation

Blood test

Procedure

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

Primary outcomes

  1. Number of patient with postoperative urethral fistula and dehiscence

    Time frame: 1 year

Secondary outcomes

  1. Re-intervention related to wound healing

    Time frame: 1 year

    Number of re-interventions for fistula or dehiscence not related to stenosis, in the first year post surgery.

  2. post-surgical complications

    Time frame: 1 year

    Total number and type of post-surgical complications

  3. Re-intervention not related to wound healing

    Time frame: 1 year

    Number of re-interventions not related to wound healing

  4. Hormone measurement

    Time frame: 2 months

    Plasmatic concentrations of Oestradiol, Testosterone, LH, FSH at inclusion and at 2 months (at the end of study treatment)

  5. Bone age evaluation

    Time frame: 14 monthes

    Hand and wrist radiography at inclusion and 1 year after surgery.

  6. Clinical tolerance of the treatment

    Time frame: 14 months

    Number and type of adverse events

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HYPOSPADES

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2011
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.