The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Information source: Russian Academy of Medical Sciences
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome; Hypogonadism
Intervention: Nebido (testosterone undecanoate) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Russian Academy of Medical Sciences Official(s) and/or principal investigator(s):
Svetlana Kalinchenko, PhD, Principal Investigator, Affiliation: Scientific Center for Endocrinology, Russia
Overall contact:
Svetlana Kalinchenko, PhD, Phone: +70951244301, Email: kalinchenko@list.ru
Summary
The objective of the study is to assess the effect of the testosterone therapy on the body
composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic
syndrome and hypogonadism.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: waist-to-hip ratio
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- A signed informed consent to participate in the study
- Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below
225 pmol/L
- Presence of the metabolic syndrome according to the IDF definition
Exclusion Criteria:
- Patients under 35 or above 70 years.
- Participation in any clinical study within 30 days before the first injection of the
drug
- Simultaneous participation in another clinical study
- Incapable subjects as well as prisoners
- Suspicion of a serious organic or mental disease according to medical history and/or
clinical examination
- Prostate cancer, breast cancer or suspicion thereof
- Presence or history of hepatic tumors
- Acute or chronic hepatic disease
- Presence of renal diseases with renal failure
- Changes in biochemical or hematological laboratory values in spite of lack of clinical
manifestations, in the investigator's opinion
- Suspected lack of the patient's compliance
- Hypersensitivity to the active substance
Locations and Contacts
Svetlana Kalinchenko, PhD, Phone: +70951244301, Email: kalinchenko@list.ru
Scientific Centre for Endocrinology RAMS, Moscow 117136, Russian Federation; Recruiting
Svetlana Kalinchenko, PhD, Phone: +7(095)1244301, Email: kalinchenko@list.ru
Yuliya Tishova, PhDstudent, Phone: +79032213276, Email: yulya_tishova@mail.ru
Tishova Yulya, PhD student, Sub-Investigator
Additional Information
Starting date: October 2005
Ending date: December 2010
Last updated: June 11, 2008
|
