Scandinavian Mirena Insertion Nulliparous Trial.

Nulliparous Clinical Trial

Official title:

Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798980
• Other study ID #: 14015
• Secondary ID: MA0710SESCAN 68/
• Status: Completed
• Phase: N/A
• First received: November 26, 2008
• Last updated: April 21, 2015
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nulliparous

Intervention

Drug:
• Mirena (BAY86-5028)
Nulliparous Women

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Marions L, Lövkvist L, Taube A, Johansson M, Dalvik H, Øverlie I. Use of the levonorgestrel releasing-intrauterine system in nulliparous women--a non-interventional study in Sweden. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):126-34. doi: 10.3109/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the insertion procedure of Mirena in nulliparous women		At the insertion time point	Yes
Secondary	Pain		At the insertion time point	Yes
Secondary	Continuation rate		12-16 weeks post insertion	Yes
Secondary	Bleeding Pattern		12-16 weeks post insertion	Yes
Secondary	Satisfaction		12-16 weeks post insertion	No

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