Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
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| ClinicalTrials.gov Identifier: NCT00434824 |
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Recruitment Status :
Completed
First Posted : February 13, 2007
Last Update Posted : April 16, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypogonadism Androgens | Drug: Oral testosterone undecanoate (Andriol) Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 322 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | November 2001 |
| Actual Primary Completion Date : | July 2004 |
| Actual Study Completion Date : | July 2004 |
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| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1
Oral testosterone undecanoate (Andriol)
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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
Other Name: Org 538 |
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Placebo Comparator: Arm 2
Placebo
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Drug: Placebo
treatment for 12 months with placebo in divided doses |
Primary Outcome Measures :
- Change from baseline on the total score of the AMS rating scale [ Time Frame: Month 6 ]
Secondary Outcome Measures :
- Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids [ Time Frame: Month 12 ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00434824 |
| Other Study ID Numbers: |
43203 |
| First Posted: | February 13, 2007 Key Record Dates |
| Last Update Posted: | April 16, 2015 |
| Last Verified: | April 2015 |
Additional relevant MeSH terms:
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Hypogonadism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |