Scandinavian Mirena Insertion Nulliparous Trial.

Bayer

Status: Completed

Conditions: Nulliparous

Treatments: Drug: Mirena (BAY86-5028)

Study type: Observational

Funder types: Industry

Identifiers

NCT00798980

SCAN 68/06

2006/0601120

MA0710SE

14015

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

224 participants in 1 patient group

Arm 1

Treatment:

Drug: Mirena (BAY86-5028)