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Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days

NCT03363997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-12-06

No results posted yet for this study

Summary

This clinical trial evaluated the pharmacokinetics and pharmacodynamics of estriol in healthy post-menopausal women after the application of one vaginal ring containing one of three different dosages of estriol (100 mg (Test 1), 300 mg (Test 2) or 600 mg (Test 3)) with continuous delivery (0.125, 0.250 or 0.500 mg/day) for 21 days. And also, characterized its safety and tolerability.

Conditions

Interventions

DRUG

Estriol 0.125 mg/day

Application of one vaginal ring

DRUG

Estriol 0.250 mg/day

Application of one vaginal ring

DRUG

Estriol 0.500 mg/day

Application of one vaginal ring

Sponsors & Collaborators

  • SocraTec R&D GmbH

    collaborator OTHER

  • Galeno Desenvolvimento de Pesquisas Clínicas

    lead OTHER_GOV

Principal Investigators

  • Gilberto De Nucci, MD · Galeno Desenvolvimento de Pesquisas Clinicas Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-23
Primary Completion
2016-12-15
Completion
2017-06-06

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363997 on ClinicalTrials.gov