Trial · NCT02413008
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Variation in Serum Levels of Follicle Stimulating Hormone (FSH) | from baseline to 12 weeks of treatment | 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) |
| Secondary | Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8 | Change from baseline to 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) |
| Secondary | Variation in Serum Levels of Luteinizing Hormone (LH) | Change from baseline to week 1, week 3, week 8 and week 12 | 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) |
| Secondary | Variation in Plasma Levels of Estriol | Change from baseline to week 1, week 3, week 8 and week 12 | Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline |
| Secondary | Variation in Plasma Levels of Estradiol | Change from baseline to week 1, week 3, week 8 and week 12 | Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline. |
| Secondary | Variation in Plasma Levels of Estrona | Change from baseline to week 1, week 3, week 8 and week 12 | Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline. |
| Secondary | Changes in Vaginal pH Between Baseline and Week 3 and Week 12 | week 3 and week 12 vs baseline | Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints |
| Secondary | Changes in Dyspareunia | week 3 and week 12 vs baseline | 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 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity |
| Secondary | Change in Pruritus or Itching From Baseline to Week 3 and Week 12 | Change 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 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity |
| Secondary | Changes in Vaginal Dryness | week 3 and week 12 vs baseline | 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 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity |
| Secondary | Changes in Total Score of Symptoms of Vaginal Atrophy | week 3 and week 12 vs baseline | 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 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. 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. |
| Secondary | Changes in Dryness of the Mucosa | 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. 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 |
| Secondary | Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline] | from baseline to week 3 and 12 | 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 |
| Secondary | Changes in Vaginal Mucosa With Flattening of Folds or Thinning | 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. 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 |
| Secondary | Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline | week 3 and week 12 vs 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. 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. |
| Secondary | Changes in Vaginal Maturation Value | week 3 and week 12 vs baseline | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02413008/registered