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

Contraception Clinical Trial

— Mirabel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590537
• Other study ID #: 15508
• Secondary ID: MA1010RU
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: October 15, 2015
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2348
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User satisfaction of the contraception method with Mirena or Copper IUD		up to 12 months	No
Secondary	Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD		up to 12 months	Yes
Secondary	Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)		up to 12 months	No
Secondary	Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)		up to 12 months	No
Secondary	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		up to 12 months	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results posting provided by Bayer.