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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01590537
First received: May 2, 2012
Last updated: August 10, 2014
Last verified: August 2014
  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).


Condition Intervention
Contraception
Drug: Levonorgestrel (Mirena, BAY86-5028)
Device: Copper IUD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • User satisfaction of the contraception method with Mirena or Copper IUD [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
  • Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2100
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
Group 2 Device: Copper IUD
Copper device, inserted intrauterine

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females who plan long-term contraception and meet criteria of inclusion and exclusion.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590537

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Russian Federation
Recruiting
Many Locations, Russian Federation
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01590537     History of Changes
Other Study ID Numbers: 15508, MA1010RU
Study First Received: May 2, 2012
Last Updated: August 10, 2014
Health Authority: Russia: Ethics Committee

Keywords provided by Bayer:
non-interventional
Mirena
Contraception
Russian Federation

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Copper
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 21, 2014