Clinical TrialID 2431
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
NCT03363997
Menopause
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2431
- Evidence Id
- 2431
- Core Evidence Id
- 2431
- Source Clinical Trial Id
- 2408
- Herb2 Clinical Trial Id
- HBCT002408
- Nct Id
- NCT03363997
- Title
- Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Menopause
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Estriol 0.125 mg/day|DRUG: Estriol 0.250 mg/day|DRUG: Estriol 0.500 mg/day
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 31
- Outcome Measure
- Measurement of estriol plasma levels, Blood sampling for the determination of plasma levels of estriol in participants of each treatment group., 0-22 days
- Sponsor Collaborator
- Galeno Desenvolvimento de Pesquisas Clínicas|SocraTec R&D GmbH
- Funded By
- OTHER_GOV
- Location
- Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME, Campinas, SP, Brazil
- Other Id
- GDN 005/16
- Start Date
- 2016-09-23
- Primary Completion Date
- 2016-12-15
- Completion Date
- 2017-06-06
- First Posted
- 2017-12-06
- Results First Posted
- Last Update Posted
- 2017-12-06
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03363997
- Title Cn
- Title En
- Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
- Bilingual Status
- semi_complete