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Clinical Trials/NCT00798980
NCT00798980CompletedNot Applicable

Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

Bayer0 sites224 target enrollmentStarted: February 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
224
Primary Endpoint
Evaluation of the insertion procedure of Mirena in nulliparous women
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
14 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Nulliparous women Mirena insertion planned as contraceptive method

Exclusion Criteria

  • •Ongoing or suspected pregnancy;
  • •Ongoing or recidivating genital infection;
  • •Cervicitis;
  • •Cervical dysplasia;
  • •Malignancy in uterus or cervix;
  • •Confirmed or suspected hormone sensitive neoplasia including breast cancer
  • •Undiagnosed abnormal uterine bleeding;
  • •Uterine anomaly including myoma if the cavity of the uterus is restricted;
  • •Conditions that cause increased risk of infections;
  • •Acute liver disease or liver tumour;
  • •Allergy to the active substance or any component of the IUD

Arms & Interventions

Arm 1

Intervention: Mirena (BAY86-5028) (Drug)

Outcomes

Primary Outcomes

Evaluation of the insertion procedure of Mirena in nulliparous women

Time Frame: At the insertion time point

Secondary Outcomes

  • Continuation rate(12-16 weeks post insertion)
  • Pain(At the insertion time point)
  • Bleeding Pattern(12-16 weeks post insertion)
  • Satisfaction(12-16 weeks post insertion)

Investigators

Sponsor
Bayer
Sponsor Class
Industry

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