Trial Condition(s):
Hypogonadism
Assessment of long term treatment with testosterone undecanoate in males with hypogonadism
Bayer Identifier:
91186
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Naumburg, Germany, 06618 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04299 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04289 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gera, Germany, 07551 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wolfsburg, Germany, 38440 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12159 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nürnberg, Germany, 90441 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07743 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eisenberg, Germany, 07607 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marburg, Germany, 35037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open one-arm study to investigate safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate (TU) in hypogonadal men at variable intervals during a 136-week to 192-week treatment including pharmacokinetics
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Efficacy and Safety of long term treatment with TU under real-life conditionsTimeframe: Every 3 months during treatment and after final injection
Secondary Outcome
- Assessment of treatment satisfaction by patientTimeframe: 6,10, and 14 injections
Additional Information
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