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Phase II multi-centre, randomised, open, comparative study of the safety and efficacy of transdermal testosterone (Testim®) compared to intramuscular testosterone depot for the induction of puberty in boys with hypogonadism and delayed puberty - Testim® in delayed puberty

Phase II multi-centre, randomised, open, comparative study of the safety and efficacy of transdermal testosterone (Testim®) compared to intramuscular testosterone depot for the induction of puberty in boys with hypogonadism and delayed puberty - Testim® in delayed puberty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005200-13-DE
Enrollment
Unknown
Registered
2007-05-02
Start date
2007-08-09
Completion date
Unknown
Last updated
2013-06-03

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

Conditions

Delayed puberty due to central (hypogonadotrophic) or peripheral (hypergonadotrophic) hypogonadism MedDRA version: 9.1 Level: LLT Classification code 10021011 Term: Hypogonadism male

Interventions

Trade Name: Testim 50 mg Gel Pharmaceutical Form: Gel INN or Proposed INN: TESTOSTERONE CAS Number: 58220 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade

Sponsors

Ipsen Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: - Written informed consent - Phenotypically and genotypically male patients - Puberty stage G1 - Testicular volume 1 year - Morning (8-10 a.m.) testosterone 12 IU/l (hypergonadotrophic) OR buserelin test: LH increase =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous treatment with testosterone for delayed puberty. - Any syndrome that makes measurement of bone age difficult - Planned operative treatment of gonadal dysfunction - Functional testes tissue present (positive hCG test and LH values within normal range (12 IU/l or less)) - Severe metabolic disturbances, e.g. renal insufficiency affecting hormone function - Patient or parents unable to give informed consent - Patient unable/unlikely to follow study protocol - Patient with psychological problems such as aggressive or inappropriate sexual behaviour that may be worsened by the treatment with testosterone

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare daily transcutaneous therapy with Testim® with the standard therapy with monthly (every four weeks) testosterone depot intramuscular injections with respect to efficacy and safety.;Secondary Objective: To investigate the acceptance of therapy with Testim compared to that of the standard therapy with intramuscular injections.;Primary end point(s): The primary efficacy endpoint is the proportion of patients with adequate pubertal development, defined as Tanner stage G5 PH5, at week 96.—

Countries

Germany

Outcome results

None listed

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