TriangleNCT02413008 · OUTCOME
Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- score on a scale
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- week 3 and week 12 vs baseline
What was measured
The signs evaluated Will be the following: vaginal mucosa with flattening of folds or thinning, dryness of the mucosa and Fragility of the mucosa. It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows: 0 Absence. The sign is not present. 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration A Total Signs Score will be calculated by summing the intensities of all the three signs of vaginal atrophy in a certain time point, thus ranging between 0 and 9.
Analysis population: postmenopausal women
Groups in this outcome
0.005% Estriol Vaginal Gel
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
Placebo Vaginal Gel
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
| Group | Source count |
|---|---|
| 0.005% Estriol Vaginal Gel | 50 |
| Placebo Vaginal Gel | 11 |
Reported measurements
Change between baseline and week 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.005% Estriol Vaginal Gel | 4.0 | Not reported | 2.0 | 5.0 | Not reported |
| Placebo Vaginal Gel | 1.0 | Not reported | 0.0 | 2.0 | Not reported |
Change between baseline and week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.005% Estriol Vaginal Gel | 5.0 | Not reported | 4.0 | 6.0 | Not reported |
| Placebo Vaginal Gel | 1.0 | Not reported | 1.0 | 3.0 | Not reported |
Source statistical analyses
- group Description
- Change in total score of signs between week 3 and baseline
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- Change in total score of signs between week 12 and baseline
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Description
- Change in total score of signs between week 3 and baseline
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- Change in total score of signs between week 12 and baseline
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.001
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 5.0
- value
- 4.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 2.0
- value
- 1.0
- title
- Change between baseline and week 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.0
- upper Limit
- 6.0
- value
- 5.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 3.0
- value
- 1.0
- title
- Change between baseline and week 12
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- The signs evaluated Will be the following: vaginal mucosa with flattening of folds or thinning, dryness of the mucosa and Fragility of the mucosa. It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows: 0 Absence. The sign is not present. 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration A Total Signs Score will be calculated by summing the intensities of all the three signs of vaginal atrophy in a certain time point, thus ranging between 0 and 9.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
- id
- OG000
- title
- 0.005% Estriol Vaginal Gel
- description
- Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
- id
- OG001
- title
- Placebo Vaginal Gel
- param Type
- MEDIAN
- population Description
- postmenopausal women
- reporting Status
- POSTED
- time Frame
- week 3 and week 12 vs baseline
- title
- Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice