MARILIA: Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01833793
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Duration (Months): 26.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Female Contraception	Drug: Levonorgestrel IUD (Mirena, BAY86-5028)

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Levonorgestrel IUD (Mirena, BAY86-5028); Women who have been prescribed Mirena in contraception; followed up for 12 months

Outcome Measures

Primary Outcome Measures

1. Proportion of Mirena users who have at least one period of Amenorrhea of at least three months [12 months]

2. Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users [12 months]

Secondary Outcome Measures

1. Proportion of Mirena users who have menstrual disorders [12 months]

2. Proportion of Mirena users with menorrhagia [12 months]

3. Cumulative rate of satisfaction in Mirena users [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 19-40 years at the time of Mirena IUD insertion

• Using Mirena only for contraception indication

• Never having used the product before

• No heavy menstrual bleeding diagnosed

• Have signed informed consent to participate in this study

Exclusion Criteria:

• Nulliparous

• Pregnancy

• Mirena's contre-indication

• Mirena for HMB

• Abnormal bleeding pattern

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Algeria

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01833793
• Other Study ID Numbers: 16314; MA1211DZ
• First Posted: Apr 17, 2013
• Last Update Posted: Sep 14, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Bayer: Mirena; Contraception; Amenorrhea
• Additional relevant MeSH terms: Amenorrhea; Levonorgestrel

Study Results

No Results Posted as of Sep 14, 2015