Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men (OHH)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01200862

First received: September 10, 2010

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2010

Last Updated Date

March 14, 2013

Start Date ^ICMJE

August 2010

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Normalization of testosterone levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01200862 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine effect of BGS649 on insulin sensitivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of BGS649 in obese men [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Assess the pharmacodynamic effect of BGS649 on glucose, insulin and lipid metabolism, and body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

Official Title ^ICMJE

An Open-label Dose Finding Study Followed by a Parallel Group, Randomized, Double-blind Study to Evaluate the Safety, Tolerability and Pharmacodynamics of 12 Week BGS649 Treatment in Obese, Hypogonadotropic Hypogonadal Men

Brief Summary

This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Obese Hypogonadotropic Hypogonadism

Intervention ^ICMJE

Drug: Investigational new drug company code: BGS649
Drug: Placebo

Study Arm (s)

Experimental: BGS649
Intervention: Drug: Investigational new drug company code: BGS649
Placebo Comparator: Placebo to BGS649
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

239

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:
- Patients with a Body Mass Index (BMI) ≥ 30 kg/m2
- Patients with a morning serum total testosterone level < 300 ng/dL on at least two separate occasions during the Screening and/or Baseline periods.
- Patients with inappropriately low gonadotropins at screening given the low testosterone:
Luteinizing hormone (LH) ≤ ULN
Follicle stimulating hormone (FSH) ≤ ULN
Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)
- Normal hypothalamic/pituitary function, including:
Prolactin: within the normal range
Thyroid stimulating hormone (TSH): within the normal range
Ferritin: within the normal range
Patients agree to use a barrier method of contraception (e.g., condom), for the duration of the study and for at least 3 months following their Study Completion visit to prevent BGS649 exposure to their partners.

Exclusion Criteria:

Patients with hypogonadism, not related to obesity or as a result of other underlying issues
Patients with significant major organ class illness (e.g. kidney or liver disease).
Other protocol-defined inclusion/exclusion criteria may apply

Gender

Male

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT01200862

Other Study ID Numbers ^ICMJE

CBGS649A2204

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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