Phase II multi-centre, randomised, open, comparative study of the safety and efficacyof transdermal testosterone (Testim®) compared to intramuscular testosteronedepot for the induction of puberty in boys with hypogonadism and delayed puberty - Testim® in delayed puberty
- Conditions
- Delayed puberty due to central (hypogonadotrophic) or peripheral (hypergonadotrophic) hypogonadismMedDRA version: 9.1Level: LLTClassification code 10021011Term: Hypogonadism male
- Registration Number
- EUCTR2006-005200-13-DE
- Lead Sponsor
- Ipsen Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
- Written informed consent
- Phenotypically and genotypically male patients
- Puberty stage G1
- Testicular volume <= 3ml
- Chronological age at least 14 years
- Bone age retarded > 1 year
- Morning (8-10 a.m.) testosterone < 0.8 nmol/l
- Hypogonadism: EITHER hCG test: failure of serum testosterone to rise in response to hCG (testosterone levels less than 2 times baseline) and spontaneous LH > 12 IU/l (hypergonadotrophic)
OR buserelin test: LH increase < 4 IU/l (hypogonadotrophic)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>
- Secondary Outcome Measures
Name Time Method