Trial Outcomes & Findings for Testosterone Gel Applied to Women With Pituitary Gland Problems (NCT NCT00144391)
NCT ID: NCT00144391
Last Updated: 2017-06-27
Results Overview
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
Transdermal Testosterone Gel
Transdermal Testosterone gel- 2.0 mg per pump dose 2 pumps per thigh per day for 6 months
|
Placebo
Placebo
placebo gel- 2 pumps per thigh per day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testosterone Gel Applied to Women With Pituitary Gland Problems
Baseline characteristics by cohort
| Measure |
Transdermal Testosterone Gel
n=11 Participants
2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
Placebo
n=9 Participants
Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 9 • n=5 Participants
|
42 years
STANDARD_DEVIATION 14 • n=7 Participants
|
43 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthschange in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
Outcome measures
| Measure |
Transdermal Testosterone Gel
n=11 Participants
2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
Placebo
n=9 Participants
Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
|---|---|---|
|
Fatigue Impact Scale
|
-22.9 units on a scale
Standard Deviation 29.5
|
2.2 units on a scale
Standard Deviation 30.7
|
Adverse Events
Transdermal Testosterone Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transdermal Testosterone Gel
n=11 participants at risk
2.0 mg per pump dose. Study patients receive either 2 pumps per thigh per day of transdermal testosterone gel or 2 pumps of placebo per thigh per day for 6 months
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
Placebo
n=9 participants at risk
Placebo
Transdermal Testosterone gel: 2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.
|
|---|---|---|
|
Endocrine disorders
hirsutism
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
Additional Information
Dr. Theodore Friedman
Charles R. Drew University of Medicine and Science
Phone: 310-668-5197
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place