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



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:10/6/2018
Start Date:May 12, 2016
End Date:May 19, 2018

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A Phase IIb Multicentre, Double-Blind, Dose-Ranging, Randomised, Placebo-Controlled Study Evaluating Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

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 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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
49
sites
New Orleans, Louisiana
698
mi
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New Orleans, LA
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Albany, New York
1309
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Albany, NY
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Anaheim, California
1155
mi
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Anaheim, CA
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5364
mi
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Ancona,
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Baltimore, Maryland
1148
mi
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Baltimore, MD
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Birmingham, Alabama
683
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Birmingham, AL
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Bradenton, Florida
1132
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Bradenton, FL
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Carlsbad, California
1141
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Carlsbad, CA
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Chandler, Arizona
844
mi
from
Chandler, AZ
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Charlotte, North Carolina
957
mi
from
Charlotte, NC
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Dallas, Texas
347
mi
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Dallas, TX
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Deland, Florida
1124
mi
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Deland, FL
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Elkridge, Maryland
1143
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Elkridge, MD
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Evansville, Indiana
559
mi
from
Evansville, IN
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Fort Myers, Florida
1206
mi
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Fort Myers, FL
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Fort Worth, Texas
348
mi
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Fort Worth, TX
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Garden City, New York
1306
mi
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Garden City, NY
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Great Neck, New York
1301
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Great Neck, NY
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Greenbrae, California
1343
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Greenbrae, CA
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Gurnee, Illinois
613
mi
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Gurnee, IL
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Henderson, Nevada
954
mi
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Henderson, NV
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Hialeah, Florida
1313
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Hialeah, FL
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Homestead, Florida
1323
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Homestead, FL
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Kenosha, Wisconsin
624
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Kenosha, WI
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Las Vegas, Nevada
960
mi
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Las Vegas, NV
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Lincoln, California
1271
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Lincoln, CA
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Los Angeles, California
1168
mi
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Los Angeles, CA
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Meridian, Idaho
1050
mi
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Meridian, ID
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Middleburg Heights, Ohio
887
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Middleburg Heights, OH
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Mobile, Alabama
740
mi
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Mobile, AL
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1156 Bowman Road
Mount Pleasant, South Carolina 29464
1067
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Mount Pleasant, SC
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Murray, Utah
778
mi
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Murray, UT
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Nashville, Tennessee
618
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Nashville, TN
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New York, New York
1225
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New York, NY
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Norfolk, Virginia
1182
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Norfolk, VA
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Omaha, Nebraska
261
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Omaha, NE
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Pearland, Texas
584
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Pearland, TX
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Phoenix, Arizona
852
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Phoenix, AZ
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Raleigh, North Carolina
1068
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Raleigh, NC
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Rochester, New York
1122
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Rochester, NY
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1210 South Vandeventer Avenue
Saint Louis, Missouri 63110
415
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Saint Louis, MO
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Saint Petersburg, Florida
1115
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Saint Petersburg, FL
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San Antonio, Texas
576
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San Antonio, TX
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San Diego, California
1142
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San Diego, CA
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Scottsdale, Arizona
842
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Scottsdale, AZ
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Smyrna, Tennessee
538
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Smyrna, TN
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Spring Hill, Tennessee
765
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Spring Hill, TN
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West Jordan, Utah
780
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West Jordan, UT
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Winston-Salem, North Carolina
976
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Winston-Salem, NC
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