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FR01 and FR20 IUS (Intrauterine System) Wearing Study

NCT01595022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-04-03

No results posted yet for this study

Summary

The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

Conditions

  • Contraception

Interventions

DRUG

Placebo: Flexi ring FR01

Intrauterine device, inserted once for 3 months

DRUG

Placebo: Flexi ring FR20

Intrauterine device, inserted once for 3 months

DRUG

Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)

Intrauterine device, inserted once for 3 months

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Finland
  • Netherlands
  • Sweden

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 NCT01595022 on ClinicalTrials.gov