HR-QoL and Sexuality in Mirena Inserted Contraception Users

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Mirena

• Registration Number: NCT00498784
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Mirena	-

Primary Outcome Measures

Name	Time	Method
Health-related QoL score	1 year

Secondary Outcome Measures

Name	Time	Method
Sexuality Index, treatment satisfaction, usual safety outcomes	1 year