HR-QoL and Sexuality in Mirena Inserted Contraception Users

Bayer141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Contraception

Interventions

MirenaDRUG

Mirena 52mg during 1 year

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Bordeaux, Gironde, France

Outcomes

Primary Outcomes

Health-related QoL score

Time frame: 1 year

Secondary Outcomes

Sexuality Index, treatment satisfaction, usual safety outcomes

Time frame: 1 year

Data from ClinicalTrials.gov

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