HR-QoL and Sexuality in Mirena Inserted Contraception Users

Contraception Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498784
• Other study ID #: 91458
• Secondary ID: 2005-002955-4230
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2007
• Last updated: January 21, 2013
• Start date: November 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Mirena
Mirena 52mg during 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related QoL score		1 year	No
Secondary	Sexuality Index, treatment satisfaction, usual safety outcomes		1 year	Yes

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