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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434824

Enrollment

322

Registered

2007-02-13

Start date

2001-11-30

Completion date

2004-07-31

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgens, Hypogonadism

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

Interventions

DRUGOral 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

DRUGPlacebo

treatment for 12 months with placebo in divided doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline on the total score of the AMS rating scale	Month 6

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026