TriangleNCT00343382 · OUTCOME
Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
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 to Week 6
What was measured
Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
Analysis population: Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
Groups in this outcome
Collective Placebo
Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
Pilocarpine 2 Times Per Day
Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
Pilocarpine 4 Times Per Day
Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
| Group | Source count |
|---|---|
| Collective Placebo | 61 |
| Pilocarpine 2 Times Per Day | 61 |
| Pilocarpine 4 Times Per Day | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Collective Placebo | 63.6 | 24.04 | Not reported | Not reported | Not reported |
| Pilocarpine 2 Times Per Day | 55.8 | 27.69 | Not reported | Not reported | Not reported |
| Pilocarpine 4 Times Per Day | 66.0 | 21.38 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1675
- statistical Method
- Kruskal-Wallis
- tested Non Inferiority
- false
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5974
- statistical Method
- Kruskal-Wallis
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1675
- statistical Method
- Kruskal-Wallis
- tested Non Inferiority
- false
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.5974
- statistical Method
- Kruskal-Wallis
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.04
- value
- 63.6
- group Id
- OG001
- spread
- 27.69
- value
- 55.8
- group Id
- OG002
- spread
- 21.38
- value
- 66.0
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 55
- units
- Participants
- description
- Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values \* 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
- id
- OG000
- title
- Collective Placebo
- description
- Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
- id
- OG001
- title
- Pilocarpine 2 Times Per Day
- description
- Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
- id
- OG002
- title
- Pilocarpine 4 Times Per Day
- param Type
- MEAN
- population Description
- Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).
- reporting Status
- POSTED
- time Frame
- Baseline to Week 6
- title
- Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
- type
- PRIMARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice