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

Use our guide to learn which trials are right for you!

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
Spring Hill, Tennessee
2099
mi
from 98109
Spring Hill, TN
Click here to add this to my saved trials
Albany, New York
2353
mi
from 98109
Albany, NY
Click here to add this to my saved trials
Anaheim, California
980
mi
from 98109
Anaheim, CA
Click here to add this to my saved trials
5583
mi
from 98109
Ancona,
Click here to add this to my saved trials
Baltimore, Maryland
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
Birmingham, Alabama
2079
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
Bradenton, Florida
2543
mi
from 98109
Bradenton, FL
Click here to add this to my saved trials
Carlsbad, California
1033
mi
from 98109
Carlsbad, CA
Click here to add this to my saved trials
Chandler, Arizona
1131
mi
from 98109
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina
2281
mi
from 98109
Charlotte, NC
Click here to add this to my saved trials
Dallas, Texas
1680
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
Deland, Florida
2527
mi
from 98109
Deland, FL
Click here to add this to my saved trials
Elkridge, Maryland
2326
mi
from 98109
Elkridge, MD
Click here to add this to my saved trials
Evansville, Indiana
1865
mi
from 98109
Evansville, IN
Click here to add this to my saved trials
Fort Myers, Florida
2618
mi
from 98109
Fort Myers, FL
Click here to add this to my saved trials
Fort Worth, Texas
1662
mi
from 98109
Fort Worth, TX
Click here to add this to my saved trials
Garden City, New York
2418
mi
from 98109
Garden City, NY
Click here to add this to my saved trials
Great Neck, New York
2412
mi
from 98109
Great Neck, NY
Click here to add this to my saved trials
Greenbrae, California
669
mi
from 98109
Greenbrae, CA
Click here to add this to my saved trials
Gurnee, Illinois
1706
mi
from 98109
Gurnee, IL
Click here to add this to my saved trials
Henderson, Nevada
885
mi
from 98109
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida
2724
mi
from 98109
Hialeah, FL
Click here to add this to my saved trials
Homestead, Florida
2734
mi
from 98109
Homestead, FL
Click here to add this to my saved trials
Kenosha, Wisconsin
1704
mi
from 98109
Kenosha, WI
Click here to add this to my saved trials
Las Vegas, Nevada
873
mi
from 98109
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, California
606
mi
from 98109
Lincoln, CA
Click here to add this to my saved trials
Los Angeles, California
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
Meridian, Idaho
399
mi
from 98109
Meridian, ID
Click here to add this to my saved trials
Middleburg Heights, Ohio
2019
mi
from 98109
Middleburg Heights, OH
Click here to add this to my saved trials
Mobile, Alabama
2151
mi
from 98109
Mobile, AL
Click here to add this to my saved trials
1156 Bowman Road
Mount Pleasant, South Carolina 29464
2426
mi
from 98109
Mount Pleasant, SC
Click here to add this to my saved trials
Murray, Utah
706
mi
from 98109
Murray, UT
Click here to add this to my saved trials
Nashville, Tennessee
1970
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana
2099
mi
from 98109
New Orleans, LA
Click here to add this to my saved trials
New York, New York
2262
mi
from 98109
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia
2430
mi
from 98109
Norfolk, VA
Click here to add this to my saved trials
Omaha, Nebraska
1367
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
Pearland, Texas
1904
mi
from 98109
Pearland, TX
Click here to add this to my saved trials
Phoenix, Arizona
1116
mi
from 98109
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina
2362
mi
from 98109
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York
2161
mi
from 98109
Rochester, NY
Click here to add this to my saved trials
1210 South Vandeventer Avenue
Saint Louis, Missouri 63110
1718
mi
from 98109
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida
2525
mi
from 98109
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
Scottsdale, Arizona
1116
mi
from 98109
Scottsdale, AZ
Click here to add this to my saved trials
Smyrna, Tennessee
1908
mi
from 98109
Smyrna, TN
Click here to add this to my saved trials
West Jordan, Utah
707
mi
from 98109
West Jordan, UT
Click here to add this to my saved trials
Winston-Salem, North Carolina
2275
mi
from 98109
Winston-Salem, NC
Click here to add this to my saved trials