ROLE OF TESTOSTERONE AND ITS METABOLITE DIHYDROTESTOSTERONE ON METABOLISM AND ON MUSCLE STRENGTH IN SUBJECTS AFFECTED BY GENEDER IDENTITY DISORDER (GID) (FtM TRANSSEXUALS) - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003251-74-IT

Enrollment

Registered

2008-07-08

Start date

2008-06-24

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

GENDER IDENTITY DISORDER (GID) (FtM TRANSSEXUALS) MedDRA version: 9.1 Level: LLT Classification code 10061976 Term: Gender identity disorder

Interventions

Trade Name: NEBID*F IM 4ML 1000MG/4ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Testosterone Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy FtM subjects, who have undergone SR surgery, will be recruited, aged between 18 and 45 years in accordance with the criteria of inclusion and exclusion below. Subjects will be informed about the nature, purpose and objectives of the study and will be requested to sign a written consent to participate in this study Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes Partecipation in other clinical trials Concomitant use of anabolic drugs thrombosis hypertension PA> 140-190 mmhg

Design outcomes

Primary

Measure	Time frame
Main Objective: - The role of testosterone versus DHT on muscle metabolism - The role of testosterone versus DHT in the development of muscle strength - The role of testosterone versus DHT in maintaining muscle strength;Secondary Objective: - To evaluate the effects of testosterone and DHT in different physiological functions, such as bone metabolism, body composition, lipid and glucidic profile;Primary end point(s): PRIMARY END- POINTS : - The role of testosterone versus DHT on muscle metabolism - The role of testosterone versus DHT in the development of muscle strength - The role of testosterone versus DHT in maintaining muscle strength	—

Measure

Time frame

Main Objective: - The role of testosterone versus DHT on muscle metabolism - The role of testosterone versus DHT in the development of muscle strength - The role of testosterone versus DHT in maintaining muscle strength;Secondary Objective: - To evaluate the effects of testosterone and DHT in different physiological functions, such as bone metabolism, body composition, lipid and glucidic profile;Primary end point(s): PRIMARY END- POINTS : - The role of testosterone versus DHT on muscle metabolism - The role of testosterone versus DHT in the development of muscle strength - The role of testosterone versus DHT in maintaining muscle strength

—

Countries

Italy

Outcome results

None listed

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