MedTrace Logo

To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development

NCT02490774 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2019-06-04

No results posted yet for this study

Summary

Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development

Conditions

  • Contraception

Interventions

DRUG

BAY1007626

Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)

DRUG

Jaydess

Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day

DRUG

Mirena

Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-22
Primary Completion
2016-05-26
Completion
2016-07-22

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02490774 on ClinicalTrials.gov