HR-QoL and Sexuality in Mirena Inserted Contraception Users

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.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bordeaux, Gironde, 33076, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirena

Drug

Mirena 52mg during 1 year

Primary outcomes

Health-related QoL score

Time frame: 1 year

Secondary outcomes

Sexuality Index, treatment satisfaction, usual safety outcomes

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Jul 10, 2007
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed