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Clinical Trials/NCT00498784
NCT00498784
Completed
Phase 4

A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.

Bayer0 sites141 target enrollmentNovember 2005
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ConditionsContraception
InterventionsMirena
DrugsMirena

Overview

Phase
Phase 4
Intervention
Mirena
Conditions
Contraception
Sponsor
Bayer
Enrollment
141
Primary Endpoint
Health-related QoL score
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
October 2007
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Bayer

Eligibility Criteria

Inclusion Criteria

  • •Healthy woman willing to, or having to switch from her OC to another contraceptive method

Exclusion Criteria

  • •Any contraindication to Mirena insertion/use

Arms & Interventions

Arm 1

Intervention: Mirena

Outcomes

Primary Outcomes

Health-related QoL score

Time Frame: 1 year

Secondary Outcomes

  • Sexuality Index, treatment satisfaction, usual safety outcomes(1 year)

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