Clinical TrialID 5599
A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
NCT02413008
Vaginal Atrophy
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5599
- Evidence Id
- 5599
- Core Evidence Id
- 5599
- Source Clinical Trial Id
- 5584
- Herb2 Clinical Trial Id
- HBCT005584
- Nct Id
- NCT02413008
- Title
- A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Vaginal Atrophy
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: estriol|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Child, Adult, Older_Adult
- Enrollment
- 61
- Outcome Measure
- 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), from baseline to 12 weeks of treatment
- Sponsor Collaborator
- ITF Research Pharma, S.L.U.|Spanish Breast Cancer Research Group
- Funded By
- INDUSTRY
- Location
- For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., L´Hospitalet de Llobregat, Barcelona, 08908, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., A Coruña, 15006, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Jaén, 23007, Spain|For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U., Madrid, 28050, 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., Stockholm, 171 77, Sweden
- Other Id
- ITFE-2026-C10|2014-004517-84
- Start Date
- 2015-10-16
- Primary Completion Date
- 2017-02-10
- Completion Date
- 2017-02-10
- First Posted
- 2015-04-09
- Results First Posted
- 2019-08-05
- Last Update Posted
- 2019-08-05
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/08/NCT02413008/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/08/NCT02413008/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02413008
- Title Cn
- Title En
- A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
- Bilingual Status
- semi_complete