HypospadiasPhase 3HYPOSPADESNCT01370798
Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications
A Phase 3 study testing promestriene, Urethroplasty and Wrist X ray in people with Hypospadias, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 36 months, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- promestriene, Urethroplasty and Wrist X ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 4 sitesFrance
- Study dates
- 26 May 2011to 18 Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 36 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
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- Not affiliated to a healthy or social security cover.
- Known tumoral risk
- Pure or mixed gonadal dysgenesis (45, X0/46,XY)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant
Bron, 69677
Hôpital Mère-Enfant
Nantes, 44093
Hôpital Robert Debré
Paris, 72015
Hôpital NECKER
Paris, 75015
About this study
Official title: 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.
- Conditions
- Hypospadias
- Being tested
- promestriene, Placebo, Urethroplasty, Wrist X ray, Blood test
- Keywords
- Severe hypospadias, local oestrogen, promestriene, Onlay-tube-onlay urethroplasty, post-operative complications, fistula dehiscence
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
promestrieneDrug
Promestriene cream 1%, 1g per day during 2 months, cutaneous application
PlaceboDrug
Placebo of promestriene cream, 1g per day during 2 months, cutaneous application
UrethroplastyProcedure or surgery
Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability)
Wrist X rayRadiation
Wrist X ray to follow the degree of bone maturation
Blood testProcedure or surgery
Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH
| Study group | Role | What they receive |
|---|---|---|
| promestriene | Experimental | Children with severe hypospadias treated with promestriene 1% Receives: Drug: promestriene; Procedure: Urethroplasty; Radiation: Wrist X ray; Procedure: Blood test |
| Placebo | Placebo comparator | Control group, children with severe hypospadias treated with Placebo. Receives: Drug: Placebo; Procedure: Urethroplasty; Radiation: Wrist X ray; Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with postoperative urethral fistula and dehiscence
Measured: 1 year
Secondary outcomes (6)
Re-intervention related to wound healing
Number of re-interventions for fistula or dehiscence not related to stenosis, in the first year post surgery.
Measured: 1 year
post-surgical complications
Total number and type of post-surgical complications
Measured: 1 year
Re-intervention not related to wound healing
Number of re-interventions not related to wound healing
Measured: 1 year
Hormone measurement
Plasmatic concentrations of Oestradiol, Testosterone, LH, FSH at inclusion and at 2 months (at the end of study treatment)
Measured: 2 months
Bone age evaluation
Hand and wrist radiography at inclusion and 1 year after surgery.
Measured: 14 monthes
Clinical tolerance of the treatment
Number and type of adverse events
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study start26 May 2011
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Mouriquand, Prof, Principal investigator, HOPITAL FEMME MERE ENFANT CHU DE LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370798
- Sponsor's protocol ID
- 2010.608
- Other IDs
- 2010-023686-22
- Acronym
- HYPOSPADES
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2011
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32386308
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications.
- ClinicalTrials.gov ID
- NCT01370798
- Acronym / sponsor ID
- HYPOSPADES / 2010.608
- Conditions
- Hypospadias
- Keywords
- Severe hypospadias, local oestrogen, promestriene, Onlay-tube-onlay urethroplasty, post-operative complications, fistula dehiscence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 May 2011 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| promestriene | Experimental | Drug: promestriene, Procedure: Urethroplasty, Radiation: Wrist X ray, Procedure: Blood testChildren with severe hypospadias treated with promestriene 1% |
| Placebo | Placebo comparator | Drug: Placebo, Procedure: Urethroplasty, Radiation: Wrist X ray, Procedure: Blood testControl group, children with severe hypospadias treated with Placebo. |
Who may qualify
- Ages
- 9 to 36 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| promestrienePromestriene cream 1%, 1g per day during 2 months, cutaneous application | Drug | promestriene |
| PlaceboPlacebo of promestriene cream, 1g per day during 2 months, cutaneous application | Drug | Placebo |
| UrethroplastyOnlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability) | Procedure or surgery | Placebo, promestriene |
| Wrist X rayWrist X ray to follow the degree of bone maturation | Radiation | Placebo, promestriene |
| Blood testHormonal dosage: Oestradiol, testosterone, FSH-LH and AMH | Procedure or surgery | Placebo, promestriene |
Primary outcome
Number of patient with postoperative urethral fistula and dehiscence
Time frame: 1 year
6 secondary outcomes
Re-intervention related to wound healing
Time frame: 1 year
post-surgical complications
Time frame: 1 year
Re-intervention not related to wound healing
Time frame: 1 year
Hormone measurement
Time frame: 2 months
Bone age evaluation
Time frame: 14 monthes
Clinical tolerance of the treatment
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 32386308Gorduza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Mouriquand, Prof principal investigator
HOPITAL FEMME MERE ENFANT CHU DE LYON
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing promestriene, Urethroplasty and Wrist X ray in people with Hypospadias, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with postoperative urethral fistula and dehiscence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.