TriangleNCT01376349 · OUTCOME
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- change in units on a scale
- Interval / dispersion
- Full Range
- Time frame
- At baseline and 12 weeks
What was measured
The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).
Analysis population: All patients that started treatment and completed their week 12 evaluation are included in this analysis.
Groups in this outcome
Arm I Low Dose DHEA
Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm II High Dose DHEA
Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm III Placebo
Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
| Group | Source count |
|---|---|
| Arm I Low Dose DHEA | 123 |
| Arm II High Dose DHEA | 114 |
| Arm III Placebo | 118 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I Low Dose DHEA | -2 | Not reported | -4 | 1 | Not reported |
| Arm II High Dose DHEA | -2 | Not reported | -4 | 1 | Not reported |
| Arm III Placebo | -1 | Not reported | -4 | 1 | Not reported |
Source statistical analyses
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.08
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.48
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.08
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.48
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4
- upper Limit
- 1
- value
- -2
- group Id
- OG001
- lower Limit
- -4
- upper Limit
- 1
- value
- -2
- group Id
- OG002
- lower Limit
- -4
- upper Limit
- 1
- value
- -1
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 114
- group Id
- OG002
- value
- 118
- units
- Participants
- description
- The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).
- dispersion Type
- Full Range
- groups
- description
- Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
- id
- OG000
- title
- Arm I Low Dose DHEA
- description
- Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
- id
- OG001
- title
- Arm II High Dose DHEA
- description
- Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
- id
- OG002
- title
- Arm III Placebo
- param Type
- MEDIAN
- population Description
- All patients that started treatment and completed their week 12 evaluation are included in this analysis.
- reporting Status
- POSTED
- time Frame
- At baseline and 12 weeks
- title
- Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks
- type
- PRIMARY
- unit Of Measure
- change in units on a scale
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Preserved source evidence · Not medical advice