Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

Treatments: Drug: Testosterone undecanoate (TU) - NebidoTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00220298

91186

306605 (Other Identifier)

Details and patient eligibility

About

This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment: 96 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency

Exclusion criteria

• Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Testosterone undecanoate (TU) - NebidoTM