Nulliparous
Conditions
Keywords
Mirena, Nulliparous, Intrauterine Devices
Brief summary
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.
Interventions
Nulliparous Women
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the insertion procedure of Mirena in nulliparous women | At the insertion time point |
Secondary
| Measure | Time frame |
|---|---|
| Pain | At the insertion time point |
| Continuation rate | 12-16 weeks post insertion |
| Bleeding Pattern | 12-16 weeks post insertion |
| Satisfaction | 12-16 weeks post insertion |
Countries
Sweden
Outcome results
None listed