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Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women

NCT03737656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-06-05

No results posted yet for this study

Summary

This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Progesterone vaginal ring

Vaginal ring with 2.0 g progesterone (sustained-release over 90-days)

Sponsors & Collaborators

  • Grünenthal, S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-05-03
Completion
2019-05-09

Countries

  • Mexico

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 NCT03737656 on ClinicalTrials.gov