Status:
COMPLETED
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Lead Sponsor:
Mereo BioPharma
Conditions:
Hypogonadotropic Hypogonadism
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subje...
Eligibility Criteria
Inclusion
- Adult male subject aged 18 to 65 years inclusive
- BMI \> 30 kg/m2 and \< 50 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
- Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments
- Other types of hypogonadotropic hypogonadism or primary hypogonadism
- Any other pituitary or hypothalamic disease
Key Trial Info
Start Date :
May 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2018
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT02730169
Start Date
May 12 2016
End Date
May 19 2018
Last Update
September 14 2022
Active Locations (63)
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1
Mereo Research Site
Birmingham, Alabama, United States
2
Mereo Research Site
Mobile, Alabama, United States
3
Mereo Research Site
Chandler, Arizona, United States
4
Mereo Research Site
Phoenix, Arizona, United States