Scandinavian Mirena Insertion Nulliparous Trial.

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00798980
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nulliparous	Drug: Mirena (BAY86-5028)

Study Design

• Study Type: Observational
• Actual Enrollment: 224 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Arm 1	Drug: Mirena (BAY86-5028); Nulliparous Women

Outcome Measures

Primary Outcome Measures

1. Evaluation of the insertion procedure of Mirena in nulliparous women [At the insertion time point]

Secondary Outcome Measures

1. Pain [At the insertion time point]

2. Continuation rate [12-16 weeks post insertion]

3. Bleeding Pattern [12-16 weeks post insertion]

4. Satisfaction [12-16 weeks post insertion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Sweden

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00798980
• Other Study ID Numbers: 14015; MA0710SE; SCAN 68/06; 2006/0601120
• First Posted: Nov 27, 2008
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by , ,: Mirena; Nulliparous; Intrauterine Devices
• Additional relevant MeSH terms: Levonorgestrel

Study Results

No Results Posted as of Apr 22, 2015