TriangleNCT00981305 · OUTCOME
Change of a Total and Other Five Domains of Female Sexual Function Index 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 and 8 weeks
What was measured
The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
Groups in this outcome
Lactate-containing Vaginal Lubricant
apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
Placebo
apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
| Group | Source count |
|---|---|
| Lactate-containing Vaginal Lubricant | 50 |
| Placebo | 57 |
Reported measurements
Total
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 2.85 | 4.10 | Not reported | Not reported | Not reported |
| Placebo | 3.81 | 5.10 | Not reported | Not reported | Not reported |
Desire
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 0.19 | 1.03 | Not reported | Not reported | Not reported |
| Placebo | 0.45 | 0.86 | Not reported | Not reported | Not reported |
Arousal
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 0.42 | 0.72 | Not reported | Not reported | Not reported |
| Placebo | 0.45 | 0.90 | Not reported | Not reported | Not reported |
Lubrication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 0.59 | 1.23 | Not reported | Not reported | Not reported |
| Placebo | 0.77 | 1.50 | Not reported | Not reported | Not reported |
Orgasm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 0.38 | 0.81 | Not reported | Not reported | Not reported |
| Placebo | 0.67 | 0.94 | Not reported | Not reported | Not reported |
Satisfaction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lactate-containing Vaginal Lubricant | 0.11 | 0.83 | Not reported | Not reported | Not reported |
| Placebo | 0.43 | 1.06 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.10
- value
- 2.85
- group Id
- OG001
- spread
- 5.10
- value
- 3.81
- title
- Total
- categories
- measurements
- group Id
- OG000
- spread
- 1.03
- value
- 0.19
- group Id
- OG001
- spread
- 0.86
- value
- 0.45
- title
- Desire
- categories
- measurements
- group Id
- OG000
- spread
- 0.72
- value
- 0.42
- group Id
- OG001
- spread
- 0.90
- value
- 0.45
- title
- Arousal
- categories
- measurements
- group Id
- OG000
- spread
- 1.23
- value
- 0.59
- group Id
- OG001
- spread
- 1.50
- value
- 0.77
- title
- Lubrication
- categories
- measurements
- group Id
- OG000
- spread
- 0.81
- value
- 0.38
- group Id
- OG001
- spread
- 0.94
- value
- 0.67
- title
- Orgasm
- categories
- measurements
- group Id
- OG000
- spread
- 0.83
- value
- 0.11
- group Id
- OG001
- spread
- 1.06
- value
- 0.43
- title
- Satisfaction
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.
- dispersion Type
- Standard Deviation
- groups
- description
- apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
- id
- OG000
- title
- Lactate-containing Vaginal Lubricant
- description
- apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week) Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline and 8 weeks
- title
- Change of a Total and Other Five Domains of Female Sexual Function Index Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice