Clinical Trial Details

Overview

Research Study Summary

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotrophic Hypogonadism

Purpose

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotrophic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

To Learn more

CW ID: 224835
Date Last Changed: June 12, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 to 65 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Adult male subject aged 18 to 65 years inclusive
  • BMI > 30 kg/m2 and ≤ kg/m2
  • Serum total testosterone concentration below the normal range
  • LH levels below the upper limit of normal
  • Oestradiol levels within or above the normal range of approved assay
  • At least two symptoms of androgen deficiency present for at least 2 months prior to the
  • first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria:
  • Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
  • Other types of hypogonadotrophic hypogonadism or primary hypogonadism
  • Any other pituitary or hypothalamic disease

Contact

Coastal Carolina Research Center
1156 Bowman Road, Suite 102
Mount Pleasant, SC 29464
Phone: 843-856-3784
Fax: 843-856-3788

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Research Center Information:

Coastal Carolina Research Center

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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