check_circleStudy Completed
Contraception
Bayer Identifier:
15508
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Non-interventional study of long-term intrauterine contraceptives acceptability and user satisfaction
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).
Key Participants Requirements
Sex
FemaleAge
20 - 40 YearsTrial summary
Enrollment Goal
2348Trial Dates
September 2011 - October 2014Phase
N/ACould I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Russia |
Primary Outcome
- User satisfaction of the contraception method with Mirena or Copper IUDdate_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUDdate_rangeTime Frame:up to 12 monthsenhanced_encryptionYesSafety Issue:
- Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)date_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
- Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)date_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
- 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 questionnairedate_rangeTime Frame:up to 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A