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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01833793
First received: March 13, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Female Contraception
Drug: Levonorgestrel IUD (Mirena, BAY86-5028)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of Mirena users who have at least one period of Amenorrhea of at least three months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Mirena users who have menstrual disorders [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of Mirena users with menorrhagia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cumulative rate of satisfaction in Mirena users [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel IUD (Mirena, BAY86-5028)
Women who have been prescribed Mirena in contraception; followed up for 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who have been prescribed Mirena for contraception.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833793

Locations
Algeria
Many Locations, Algeria
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01833793     History of Changes
Other Study ID Numbers: 16314, MA1211DZ
Study First Received: March 13, 2013
Last Updated: May 19, 2014
Health Authority: Algeria: Ministry of Health

Keywords provided by Bayer:
Mirena
Contraception
Amenorrhea

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 28, 2014