Clinical TrialID 2432
Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
NCT04574999
Vaginal Atrophy
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2432
- Evidence Id
- 2432
- Core Evidence Id
- 2432
- Source Clinical Trial Id
- 2409
- Herb2 Clinical Trial Id
- HBCT002409
- Nct Id
- NCT04574999
- Title
- Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
- Status
- Completed
- Phase
- Phase 3
- 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|OTHER: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Child, Adult, Older_Adult
- Enrollment
- 167
- Outcome Measure
- Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment, Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree., At week 12/Early withdrawal
- Sponsor Collaborator
- Italfarmaco S.A
- Funded By
- INDUSTRY
- Location
- Hospital Sierrallana, Torrelavega, Cantabria, 39300, Spain|Hospital Ruber Internacional, Madrid, Castiglia, 28034, Spain|Centre Mèdic Teknon S.L., Barcelona, Catalogna, 08022, Spain|Fundació de Gestió Sanitària de l'Hospital de la Santa. Creu i Sant Pau, Barcelona, Catalogna, 08025, Spain|Complejo Hospitalario Virgen de las Nieves, Granada, 18014, Spain|Fundación Jiménez Díaz, Madrid, 28040, Spain|Complejo Universitario La Paz, Madrid, 28046, Spain|Hospital Universitario Virgen de la Arrixaca, Murcia, 30120, Spain|Hospital Universitario Central de Asturias, Oviedo, 33006, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital la Ribera de Alzira, Valencia, 46600, Spain|Hospital do Meixoeiro, Vigo, 36200, Spain
- Other Id
- ITFE-2026C2
- Start Date
- 2008-01-25
- Primary Completion Date
- 2009-02-23
- Completion Date
- 2009-02-23
- First Posted
- 2020-10-05
- Results First Posted
- 2020-12-11
- Last Update Posted
- 2020-12-11
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04574999
- Title Cn
- Title En
- Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
- Bilingual Status
- semi_complete