TriangleNCT01697345 · OUTCOME
Total Female Sexual Function Index (FSFI) Score
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 Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score \< 26.5 suggests female sexual dysfunction.
Groups in this outcome
FSFI Total Score (Pretest)
Administered to participants prior to starting vaginal testosterone therapy.
FSFI Total Score (Postteset)
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 Total Score (Pretest) | 12 |
| FSFI Total Score (Postteset) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FSFI Total Score (Pretest) | 8.691 | 3.803 | Not reported | Not reported | Not reported |
| FSFI Total Score (Postteset) | 18.783 | 7.050 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -13.928
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.256
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 6.0378
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0005
- param Type
- Mean Difference (Final Values)
- param Value
- -10.092
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -13.928
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.256
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 6.0378
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0005
- param Type
- Mean Difference (Final Values)
- param Value
- -10.092
- statistical Method
- t-test, 2 sided
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.803
- value
- 8.691
- group Id
- OG001
- spread
- 7.050
- value
- 18.783
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score \< 26.5 suggests female sexual dysfunction.
- dispersion Type
- Standard Deviation
- groups
- description
- Administered to participants prior to starting vaginal testosterone therapy.
- id
- OG000
- title
- FSFI Total 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 Total Score (Postteset)
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline, 4 weeks
- title
- Total Female Sexual Function Index (FSFI) Score
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice