TriangleNCT01697345 · OUTCOME
FSFI Lubrication Domain
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 4 weeks
What was measured
The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Groups in this outcome
FSFI Lubrication Domain Score (Pretest)
Administered to participants prior to starting vaginal testosterone therapy.
FSFI Lubrication Domain Score (Posttest)
Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
| Group | Source count |
|---|---|
| FSFI Lubrication Domain Score (Pretest) | 12 |
| FSFI Lubrication Domain Score (Posttest) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FSFI Lubrication Domain Score (Pretest) | 1.175 | 0.620 | Not reported | Not reported | Not reported |
| FSFI Lubrication Domain Score (Posttest) | 2.675 | 1.929 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.692
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.308
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.876
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.018
- param Type
- Mean Difference (Final Values)
- param Value
- -1.500
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -2.692
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.308
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.876
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.018
- param Type
- Mean Difference (Final Values)
- param Value
- -1.500
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.620
- value
- 1.175
- group Id
- OG001
- spread
- 1.929
- value
- 2.675
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
- dispersion Type
- Standard Deviation
- groups
- description
- Administered to participants prior to starting vaginal testosterone therapy.
- id
- OG000
- title
- FSFI Lubrication Domain Score (Pretest)
- description
- Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
- id
- OG001
- title
- FSFI Lubrication Domain Score (Posttest)
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline, 4 weeks
- title
- FSFI Lubrication Domain
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice