Trial Condition(s):

Contraception

Non-interventional study of long-term intrauterine contraceptives acceptability and user satisfaction (Mirabel)

Bayer Identifier:

15508

ClinicalTrials.gov Identifier:

NCT01590537

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

Inclusion Criteria
- Women 20-40 years old
 - Parity ≥ 1 child 
 - Requesting long-term contraception
 - Written informed consent.
Exclusion Criteria
- in accordance with the current leaflet

Trial Summary

Enrollment Goal
2348
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 

Trial Design