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

NCT03343912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-05-07

No results posted yet for this study

Summary

This clinical trial is performed as proof of pharmacological action investigation by demonstration of ovulation inhibition (dose-response study) under treatment with three Test vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).

Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as pharmacodynamic surrogate parameters for characterization of the treatment effect on the endogenous hormones.

Blood samples for determination of E3 and TMG in plasma will be collected in order to characterize pharmacokinetic parameters.

Additionally, local tolerability characterized by gynecological inspection of the vaginal mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is planned to be assessed

Conditions

  • Pregnancy

Interventions

DRUG

Estriol 0.400 mg/day and Trimegestone 0.06 mg/day

Vaginal ring with a nominal delivery rate of 0.400 mg/d estriol (E3) and 0.06 mg/d trimegestone (TMG), vaginal application

DRUG

Estriol 0.300 mg/day and Trimegestone 0.12 mg/day

Vaginal ring with a nominal delivery rate of 0.300 mg/d estriol (E3) and 0.12 mg/d trimegestone (TMG), vaginal application

DRUG

Estriol 0.200 mg/day and Trimegestone 0.18 mg/day

Vaginal ring with a nominal delivery rate of 0.200 mg/d estriol (E3) and 0.18 mg/d trimegestone (TMG), vaginal application

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. - ME

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2018-01-12
Completion
2018-02-15

Countries

  • Brazil

Study Locations

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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 NCT03343912 on ClinicalTrials.gov