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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	3 June 2013
Main ID:	EUCTR2006-005200-13-DE
Date of registration:	02/05/2007
Prospective Registration:	Yes
Primary sponsor:	Ipsen Pharma GmbH
Public title:	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
Scientific title:	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
Date of first enrolment:	09/08/2007
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005200-13
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Germany

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- 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

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

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 Name: Testosteron-Depot JENAPHARM
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TESTOSTERONE ENANTATE
CAS Number: 315377
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Secondary Objective: To investigate the acceptance of therapy with Testim compared to that of the standard therapy with intramuscular injections.

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.

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.

Secondary Outcome(s)

Secondary ID(s)

A-94-00500-004

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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