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Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

NCT01590537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2348

Last updated 2015-10-16

No results posted yet for this study

Summary

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

Conditions

  • Contraception

Interventions

DRUG

Levonorgestrel (Mirena, BAY86-5028)

intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel

DEVICE

Copper IUD

Copper device, inserted intrauterine

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-03-31
Completion
2014-10-31

Countries

  • Russia

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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 NCT01590537 on ClinicalTrials.gov