NCT01697345 · OUTCOME
FSFI Pain 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 score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.
Groups in this outcome
FSFI Pain Domain Score (Pretest)
Administered to participants prior to starting vaginal testosterone therapy.
FSFI Pain 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 Pain Domain Score (Pretest) | 12 |
| FSFI Pain Domain Score (Posttest) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FSFI Pain Domain Score (Pretest) | 0.933 | 0.875 | Not reported | Not reported | Not reported |
| FSFI Pain Domain Score (Posttest) | 3.500 | 2.276 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -3.706
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.428
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.793
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0005
- param Type
- Mean Difference (Final Values)
- param Value
- -2.567
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -3.706
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -1.428
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.793
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0005
- param Type
- Mean Difference (Final Values)
- param Value
- -2.567
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.875
- value
- 0.933
- group Id
- OG001
- spread
- 2.276
- value
- 3.500
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain 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 Pain 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 Pain Domain Score (Posttest)
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline, 4 weeks
- title
- FSFI Pain Domain
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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