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The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism

The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000315516
Acronym
TU/TU study
Enrollment
40
Registered
2006-07-21
Start date
2006-07-17
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study is designed to determine whether men with androgen deficiency prefer a long acting injection that requires administration each three months or whether they prefer subcutaneously implanted testosterone pellets administered approximately each 6 months.

Interventions

40 men with classical androgen deficiency will trial both testosterone undecanoate 1000mg injections and 4 x 200mg Testosterone Implant pellets in a randomised sequence over a period of approximately one year

Sponsors

Schering Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Established androgen deficiency requiring testosterone replacement therapy. Otherwise medically stable. Able to understand and comply with the study design.

Exclusion criteria

Known contraindications to androgen therapy (eg. prostate cancer). Known allergy to castor oil vehicle of injections. Known significant systemic or mental illness.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026