Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00434824

Purpose

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	Intervention	Phase
Hypogonadism Androgens	Drug: Oral testosterone undecanoate (Andriol) Drug: Placebo	Phase II

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Organon:

Primary Outcome Measures:

Change from baseline on the total score of the AMS rating scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Enrollment:	322
Study Start Date:	November 2001
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator Oral testosterone undecanoate (Andriol)	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
Arm 2: Placebo Comparator Placebo	Drug: Placebo treatment for 12 months with placebo in divided doses

Eligibility

Ages Eligible for Study:	50 Years and older
Genders 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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	43203
Study First Received:	February 12, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00434824
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 13, 2009