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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00434824
Other study ID # 43203
Secondary ID
Status Completed
Phase Phase 2
First received February 12, 2007
Last updated April 15, 2015
Start date November 2001
Est. completion date July 2004

Study information

Verified date April 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.

Specifically, we have studied the effects on:

- symptoms suggestive of low testosterone levels

- blood testosterone and other hormone levels

- bone mass

- muscle mass and fat mass

- muscle strength

- prostate

- lipids, hematocrit


Recruitment information / eligibility

Status Completed
Enrollment 322
Est. completion date July 2004
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Subjects were at least 50 years of age

- A body mass index (BMI) between 18 and 34 kg/m^2

- Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)

- Calculated free testosterone measurement of <0.26 nmol/L in the morning

Exclusion Criteria:

- History or current diagnosis of breast or prostate cancer

- any clinically significant abnormal finding on physical examination including the prostate

- Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)

- Prostate specific antigen (PSA) level > 4 ng/mL at screening

- Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism

- Hyperprolactinaemia or treatment with prolactin-lowering drugs

- History of known chronic polycythemia and/or hematocrit >50% at screening

- History or presence of severe sleep apnea

- Unstable or untreated endocrine disorders

- History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial

- Use of medication that would interfere with the efficacy and safety objectives of the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oral testosterone undecanoate (Andriol)
treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
Placebo
treatment for 12 months with placebo in divided doses

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline on the total score of the AMS rating scale Month 6 No
Secondary Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids Month 12 Yes
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