Effect of Tostran 2% Gel on Growth, Development & Bone Turnover in Hypogonadal Adolescent Boys - Tostran Gel in Hypogonadal Adolescents

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005640-25-GB

Enrollment

Registered

2008-03-26

Start date

2008-05-08

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed puberty or hypogonadism in boys requiring pubertal induction. MedDRA version: 9.1 Level: LLT Classification code 10021011 Term: Hypogonadism male MedDRA version: 9.1 Level: LLT Classification code 10043335 Term: Testicular hypogonadism MedDRA version: 9.1 Level: LLT Classification code 10052649 Term: Primary hypogonadism MedDRA version: 9.1 Level: LLT Classification code 10059594 Term: Secondary hypogonadism MedDRA version: 9.1 Level: LLT Classification code 10059597 Term: Central h

Interventions

Trade Name: Tostran 2% Gel Product Name: NA Product Code: NA Pharmaceutical Form: Gel INN or Proposed INN: TESTOSTERONE CAS Number: 58220 Concentration unit: % (W/W) percent weight/weight Concentratio

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Boys who are being started on testosterone replacement therapy for clinical indications. Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence of any other endocrinopathy or inadequately controlled chronic disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the effect of Testosterone 2% gel application on pubertal development, growth and bone-turnover in boys requiring testosterone replacement therapy. Main Outcome Measures 1. Change in pubertal status 2. Change in linear growth 3. Change in markers of bone formation and resorption ;Secondary Objective: 1. To ensure tolerability 2. To assess changes in salivary levels of testosterone;Primary end point(s): Evaluation of primary outcome measures at end of the two treatment periods within the cross-over study.	—

Measure

Time frame

Main Objective: Study the effect of Testosterone 2% gel application on pubertal development, growth and bone-turnover in boys requiring testosterone replacement therapy. Main Outcome Measures 1. Change in pubertal status 2. Change in linear growth 3. Change in markers of bone formation and resorption ;Secondary Objective: 1. To ensure tolerability 2. To assess changes in salivary levels of testosterone;Primary end point(s): Evaluation of primary outcome measures at end of the two treatment periods within the cross-over study.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026