Trial Outcomes & Findings for Testosterone Treatment for Multiple Sclerosis (NCT NCT00405353)
NCT ID: NCT00405353
Last Updated: 2019-11-22
Results Overview
as assessed by Voxel-Based Morphometry
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
Testosterone Arm/ Group
All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testosterone Treatment for Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Testosterone Arm/ Group
n=10 Participants
All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically. Brain MRIs were obtained every month from baseline (month 0) until the end of the trial (month 18). All 10 subjects completed all nineteen monthly scans.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
10 patients
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsas assessed by Voxel-Based Morphometry
Outcome measures
| Measure |
Testosterone Arm/ Group
n=10 Participants
All subjects underwent a 6-month observation period, followed by 12 months of open label testosterone treatment, using 10g of gel containing 100mg of testosterone (Androgel) applied topically.
|
|---|---|
|
Whole Brain Atrophy Rate
|
.82 percent change in brain volume
Interval 0.78 to 0.84
|
Adverse Events
Testosterone Arm/ Group
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