Scandinavian Mirena Insertion Nulliparous Trial.

Bayer224 enrolled

Overview

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

Study Type

OBSERVATIONAL

Enrollment

224

Conditions

Nulliparous

Interventions

Mirena (BAY86-5028)DRUG

Nulliparous Women

Eligibility

Sex: FEMALEMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Nulliparous women Mirena insertion planned as contraceptive method Exclusion Criteria: * Ongoing or suspected pregnancy; * Ongoing or recidivating genital infection; * Cervicitis; * Cervical dysplasia; * Malignancy in uterus or cervix; * Confirmed or suspected hormone sensitive neoplasia including breast cancer * Undiagnosed abnormal uterine bleeding; * Uterine anomaly including myoma if the cavity of the uterus is restricted; * Conditions that cause increased risk of infections; * Acute liver disease or liver tumour; * Allergy to the active substance or any component of the IUD

Locations (1)

Unnamed facility

Many Locations, Sweden

Outcomes

Primary Outcomes

Evaluation of the insertion procedure of Mirena in nulliparous women

Time frame: At the insertion time point

Secondary Outcomes

Pain

Time frame: At the insertion time point

Continuation rate

Time frame: 12-16 weeks post insertion

Bleeding Pattern

Time frame: 12-16 weeks post insertion

Satisfaction

Time frame: 12-16 weeks post insertion

Data from ClinicalTrials.gov

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