TriangleNCT04493333 · OUTCOME
Difference in Vaginal Dryness Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12
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
- 12 weeks (±1 week)
What was measured
The min and the max are both 0 which make the range also 0. These were obtained from subtracting each participant's score at baseline from their score at week 12. Only 2 participants had week 12 scores. These scores were both 1. Of the baseline scores, these 2 participants both had scores of 1 again. If 2 participants with the other 6 have baseline dyspareunia scores on the BSSC-W, then 7 participants have a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of vaginal dryness (problem with decreased vaginal lubrication) while 0 indicates absence of vaginal dryness (or an absence of this problem of decreased vaginal lubrication), so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
Analysis population: Out of 8 participants assigned to a treatment arm, only 2 took the BSSC-W at both the baseline and 12-week visits.
Groups in this outcome
Intrarosa & Standard of Care Aromatase Inhibitor
Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
Replens & Standard of Care Aromatase Inhibitor
Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
| Group | Source count |
|---|---|
| Intrarosa & Standard of Care Aromatase Inhibitor | 2 |
| Replens & Standard of Care Aromatase Inhibitor | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intrarosa & Standard of Care Aromatase Inhibitor | 0.00 | 0.00 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- The min and the max are both 0 which make the range also 0. These were obtained from subtracting each participant's score at baseline from their score at week 12. Only 2 participants had week 12 scores. These scores were both 1. Of the baseline scores, these 2 participants both had scores of 1 again. If 2 participants with the other 6 have baseline dyspareunia scores on the BSSC-W, then 7 participants have a score of 1 and 1 participant had a score of 0. This would make the min, max, and range 0, 1, and 1 respectively. As for which value represents a better or worse outcome, 1 indicates presence of vaginal dryness (problem with decreased vaginal lubrication) while 0 indicates absence of vaginal dryness (or an absence of this problem of decreased vaginal lubrication), so 1 is a worse outcome than 0. Subscales are not combined here to produce a total score.
- dispersion Type
- Standard Deviation
- groups
- description
- Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
- id
- OG000
- title
- Intrarosa & Standard of Care Aromatase Inhibitor
- description
- Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
- id
- OG001
- title
- Replens & Standard of Care Aromatase Inhibitor
- param Type
- MEAN
- population Description
- Out of 8 participants assigned to a treatment arm, only 2 took the BSSC-W at both the baseline and 12-week visits.
- reporting Status
- POSTED
- time Frame
- 12 weeks (±1 week)
- title
- Difference in Vaginal Dryness Scores on the Brief Sexual Symptom Checklist for Women (BSSC-W) From Baseline to Week 12
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice