Trial Outcomes & Findings for Hypogonadotropic Hypogonadism in Obese Young Males (NCT NCT03245827)
NCT ID: NCT03245827
Last Updated: 2022-06-29
Results Overview
after clomiphene or placebo treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-06-29
Participant Flow
Participant milestones
| Measure |
Obese Males With Hypogonadism-active
Subjects will be randomized to receive clomiphene capsules
Clomiphene: clomiphene capsule 25mg twice a week
|
Obese Males With Hypogonadism-placebo
Subjects will be randomized to receive placebo capsules
Placebo: placebo capsule 25mg twice a week
|
Obese Males With Normal Testosterone
comparison group
|
Lean Males With Normal Testosterone
comparison group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
3
|
5
|
|
Overall Study
COMPLETED
|
1
|
0
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypogonadotropic Hypogonadism in Obese Young Males
Baseline characteristics by cohort
| Measure |
Obese Males With Hypogonadism-active
n=1 Participants
Subjects will be randomized to receive clomiphene capsules
Clomiphene: clomiphene capsule 25mg twice a week
|
Obese Males With Hypogonadism-placebo
Subjects will be randomized to receive placebo capsules
Placebo: placebo capsule 25mg twice a week
|
Obese Males With Normal Testosterone
n=3 Participants
comparison group
|
Lean Males With Normal Testosterone
n=5 Participants
comparison group
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 0 • n=99 Participants
|
—
|
28 years
STANDARD_DEVIATION 2 • n=206 Participants
|
21.8 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
23.9 years
STANDARD_DEVIATION 3.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Only one volunteer was randomized.
after clomiphene or placebo treatment
Outcome measures
| Measure |
Obese Males With Hypogonadism-active
n=1 Participants
Subjects will be randomized to receive clomiphene capsules
Clomiphene: clomiphene capsule 25mg twice a week
|
Obese Males With Hypogonadism-placebo
Subjects will be randomized to receive placebo capsules
Placebo: placebo capsule 25mg twice a week
|
|---|---|---|
|
Serum Free Testosterone
|
85 pg/ml
Standard Deviation NA
NA is used for standard deviation because there was only one volunteer.
|
—
|
Adverse Events
Obese Males With Hypogonadism-active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese Males With Hypogonadism-placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese Males With Normal Testosterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lean Males With Normal Testosterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place