| Primary | Variation in Serum Levels of Follicle Stimulating Hormone (FSH) | Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation) | postmenopausal participants | Posted | | Median | Inter-Quartile Range | mIU/ml | | from baseline to 12 weeks of treatment | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-2.8(-13.1 to 7.4)
- OG0011.4(-5.4 to 15.7)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon. The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit. | Wilcoxon (Mann-Whitney) | | 0.10 | | | | | | | | | | | | | | Other | The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test). |
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| Secondary | Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8 | Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation) | | Posted | | Mean | Inter-Quartile Range | mIU/ml | | Change from baseline to week 1, week 3 and week 8 | | | | ID | Title | Description |
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| OG000 | 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 estriol: 0.005% estriol vaginal gel | | OG001 | 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: placebo vaginal gel |
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| Secondary | Variation in Serum Levels of Luteinizing Hormone (LH) | Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH compare to natural physiological variability ( screening-baseline variation) | | Posted | | Median | Inter-Quartile Range | mIU/ml | | Change from baseline to week 1, week 3, week 8 and week 12 | | | | ID | Title | Description |
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| OG000 | 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 estriol | | OG001 | 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 |
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| Secondary | Variation in Plasma Levels of Estriol | Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline | | Posted | | Median | Inter-Quartile Range | pg/mL | | Change from baseline to week 1, week 3, week 8 and week 12 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Variation in Plasma Levels of Estradiol | Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline. | | Posted | | Median | Inter-Quartile Range | pg/mL | | Change from baseline to week 1, week 3, week 8 and week 12 | | | | ID | Title | Description |
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| OG000 | 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 estriol | | OG001 | 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 |
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| Secondary | Variation in Plasma Levels of Estrona | Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline. | | Posted | | Median | Inter-Quartile Range | pg/mL | | Change from baseline to week 1, week 3, week 8 and week 12 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Vaginal pH Between Baseline and Week 3 and Week 12 | Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints | | Posted | | Mean | Inter-Quartile Range | units on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 estriol | | OG001 | 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 |
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| Secondary | Changes in Dyspareunia | Changes in dyspareunia from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown 0 Absence. The symptom is not present
- The symptom is of mild intensity, without interfering in the patient's activity
- The symptom is of moderate intensity, causing obvious discomfort to the patient
- The symptom is stated as very irritating and severe in intensity
| | Posted | | Median | Inter-Quartile Range | score on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Change in Pruritus or Itching From Baseline to Week 3 and Week 12 | Change in pruritus or itching from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present
- The symptom is of mild intensity, without interfering in the patient's activity
- The symptom is of moderate intensity, causing obvious discomfort to the patient
- The symptom is stated as very irritating and severe in intensity
| | Posted | | Median | Inter-Quartile Range | units on a scale | | Change from baseline to week 3 and week 12 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Vaginal Dryness | Change in vaginal dryness puntuation score from baseline to w3 and w12 Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present
- The symptom is of mild intensity, without interfering in the patient's activity
- The symptom is of moderate intensity, causing obvious discomfort to the patient
- The symptom is stated as very irritating and severe in intensity
| | Posted | | Median | Inter-Quartile Range | units on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 estriol | | OG001 | 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 |
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| Secondary | Changes in Total Score of Symptoms of Vaginal Atrophy | Changes in Symptoms of vaginal atrophy (vaginal dryness, dyspareunia and pruritus) at week 3 and week 12 vs baseline. Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present
- The symptom is of mild intensity, without interfering in the patient's activity
- The symptom is of moderate intensity, causing obvious discomfort to the patient
- The symptom is stated as very irritating and severe in intensity A Global Symptoms Score will be calculated by summing the intensities of all the three symptoms of vaginal atrophy in a certain time point, thus ranging between 0 and 9.
| | Posted | | Median | Inter-Quartile Range | score on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Dryness 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.
- The sign is present and is considered a mild alteration
- The sign is present and is considered a moderate alteration
- The sign is present and is considered a severe alteration
| | Posted | | Median | Inter-Quartile Range | score on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline] | 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.
- The sign is present and is considered a mild alteration
- The sign is present and is considered a moderate alteration
- The sign is present and is considered a severe alteration
| | Posted | | Median | Inter-Quartile Range | score on a scale | | from baseline to week 3 and 12 | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Vaginal Mucosa With Flattening of Folds or Thinning | 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.
- The sign is present and is considered a mild alteration
- The sign is present and is considered a moderate alteration
- The sign is present and is considered a severe alteration
| | Posted | | Median | Inter-Quartile Range | score on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline | 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.
- The sign is present and is considered a mild alteration
- The sign is present and is considered a moderate alteration
- 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.
| | Posted | | Median | Inter-Quartile Range | score on a scale | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | Changes in Vaginal Maturation Value | Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). | | Posted | | Median | Inter-Quartile Range | % of cells | | week 3 and week 12 vs baseline | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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