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Scandinavian Mirena Insertion Nulliparous Trial.

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nulliparous

Intervention: Mirena (BAY86-5028) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Evaluation of the insertion procedure of Mirena in nulliparous women

Secondary outcome:

Pain

Continuation rate

Bleeding Pattern

Satisfaction

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Many Locations, Sweden
Additional Information

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: February 2007
Last updated: April 21, 2015

Page last updated: August 23, 2015

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