Scandinavian Mirena Insertion Nulliparous Trial.

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Levonorgestrel

Criteria

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