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

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    Recruiting
Updated on 25 March 2021

Summary

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

Description

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.

Details
Clinical Study IdentifierTX150137
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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