Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452322
Status:
COMPLETED
Last Update Posted:
2007-03-27
First Post:
2007-03-26
Brief Title:
Safety of Testosterone Undecanoate im in Hypogonadal Men
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate im in Hypogonadal Men
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment of male hypogonadism by testosterone substitution has be monitored in terms of safety This study relates to safety of a new long-acting preparation
Detailed Description:
A reliable form of androgen substitution therapy regarding kinetics tolerance and restoration of androgenicity is paramount in hypogonadal men Intramuscular injection of the long-acting ester testosterone undecanoate TU offers a new modality
The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders in hypogonadal men treated with this new formulation
This is a longitudinal prospective one-arm open intervention and observation trial A minimum of 5 individual assessments is a prerequisite Investigated modulators of safety parameters entering regression models are nadir andor delta total testosterone concentrations body mass index BMI and age
The setting Andrological outpatient department
The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders in hypogonadal men treated with this new formulation
This is a longitudinal prospective one-arm open intervention and observation trial A minimum of 5 individual assessments is a prerequisite Investigated modulators of safety parameters entering regression models are nadir andor delta total testosterone concentrations body mass index BMI and age
The setting Andrological outpatient department
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EK 78a97Nie1 | None | None | None |