Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)

Hypogonadism Clinical Trial

Official title:

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434824
• Other study ID #: 43203
• 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

• Androgens
• Hypogonadism

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