Trial Condition(s):

Nulliparous

Scandinavian Mirena Insertion Nulliparous Trial.

Bayer Identifier:

14015

ClinicalTrials.gov Identifier:

NCT00798980

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
224
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Sweden

Status
Completed
 

Trial Design