HR-QoL and Sexuality in Mirena Inserted Contraception Users

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00498784

Enrollment

141

Registered

2007-07-10

Start date

2005-11-30

Completion date

2007-10-31

Last updated

2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Intra-uterine contraception, Intrauterine Devices

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.

Interventions

DRUGMirena

Mirena 52mg during 1 year

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Health-related QoL score	1 year

Secondary

Measure	Time frame
Sexuality Index, treatment satisfaction, usual safety outcomes	1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026