check_circleStudy Completed
Nulliparous
Bayer Identifier:
14015
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Scandinavian Mirena Insertion Nulliparous Trial.
Trial purpose
In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.
Key Participants Requirements
Sex
FemaleAge
14 YearsTrial summary
Enrollment Goal
224Trial Dates
February 2007 - November 2009Phase
N/ACould I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Sweden |
Primary Outcome
- Evaluation of the insertion procedure of Mirena in nulliparous womendate_rangeTime Frame:At the insertion time pointenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Paindate_rangeTime Frame:At the insertion time pointenhanced_encryptionYesSafety Issue:
- Continuation ratedate_rangeTime Frame:12-16 weeks post insertionenhanced_encryptionYesSafety Issue:
- Bleeding Patterndate_rangeTime Frame:12-16 weeks post insertionenhanced_encryptionYesSafety Issue:
- Satisfactiondate_rangeTime Frame:12-16 weeks post insertionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A