Clinical TrialID 5600
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
NCT02967510
Vaginal Atrophy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5600
- Evidence Id
- 5600
- Core Evidence Id
- 5600
- Source Clinical Trial Id
- 5585
- Herb2 Clinical Trial Id
- HBCT005585
- Nct Id
- NCT02967510
- Title
- Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Vaginal Atrophy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Estriol|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 283
- Outcome Measure
- Change From Baseline to Week 12 in the Severity of Vaginal Dryness, Percentage of Subjects with change from baseline to week 12 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome., From baseline to week 12|Change From Baseline to Week 12 in Vaginal pH, Change from Baseline to Week 12 in Vaginal pH was reported. A decrease in pH compare to Baseline represents a positive outcome., Baseline to Week 12|Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium., Change from Baseline to week 12 in the proportion of superficial cells of the vaginal epithelium was reported., Baseline to Week 12|Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium., Change from Baseline to Week 12 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to Baseline represents a positive outcome., Baseline to Week 12
- Sponsor Collaborator
- ITF Research Pharma, S.L.U.
- Funded By
- INDUSTRY
- Location
- For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U, Brno, 602 00, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Ceske Budejovice, 370 01, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Olomouc, 779 00, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Olomouc, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Pisek, 397 01, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Prague, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Vsetin, Czechia|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U, Szeged, 6725, Hungary|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U, Szekesfehervar, 8000, Hungary|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Szentes, 6725, Hungary|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Tatabanya, 2800, Hungary|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Catania, 95123, Italy|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Catanzaro, 88100, Italy|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Modena, 41124, Italy|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Pavia, 27100, Italy|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Siena, 53100, Italy|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Barcelona, 80022, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Murcia, 30120, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Santander, 39008, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Valencia, 46010, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Huddinge, 141 86, Sweden|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Kungsbacka, 434 30, Sweden|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Stockholm, 171 76, Sweden
- Other Id
- ITFE-2092-C1|2015-005787-42
- Start Date
- 2016-10
- Primary Completion Date
- 2018-05
- Completion Date
- 2018-05
- First Posted
- 2016-11-18
- Results First Posted
- 2019-09-25
- Last Update Posted
- 2019-09-25
- Study Document
- Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/10/NCT02967510/SAP_000.pdf|Study Protocol, https://cdn.clinicaltrials.gov/large-docs/10/NCT02967510/Prot_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02967510
- Title Cn
- Title En
- Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
- Bilingual Status
- semi_complete