Clinical TrialID 2430

Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings

NCT03343912

Pregnancy

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Record Fields

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Clinical Trial Id
2430
Evidence Id
2430
Core Evidence Id
2430
Source Clinical Trial Id
2407
Herb2 Clinical Trial Id
HBCT002407
Nct Id
NCT03343912
Title
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Pregnancy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Intervention
DRUG: Estriol 0.400 mg/day and Trimegestone 0.06 mg/day|DRUG: Estriol 0.300 mg/day and Trimegestone 0.12 mg/day|DRUG: Estriol 0.200 mg/day and Trimegestone 0.18 mg/day
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Intervention Purpose
Prevention
Gender
Female
Age
Adult
Enrollment
36
Outcome Measure
Measurement of E2 and PG plasma levels, Blood sampling for the determination of plasma levels of E2 and PG, in participants of each treatment group, as surrogate variables for treatment response., 0 - 41 days|Measurement of E3 and TMG plasma levels, Blood sampling for the determination of plasma levels of E3 and TMG, in participants of each treatment group., 0 - 23 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 012/17
Start Date
2017-11-10
Primary Completion Date
2018-01-12
Completion Date
2018-02-15
First Posted
2017-11-17
Results First Posted
Last Update Posted
2020-05-07
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03343912
Title Cn
Title En
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
Bilingual Status
semi_complete