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Trial record 20 of 597 for:    contraception AND (woman OR women OR female) NOT (male OR men)

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

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ClinicalTrials.gov Identifier: NCT01833793
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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 : February 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Proportion of Mirena users who have at least one period of Amenorrhea of at least three months [ Time Frame: 12 months ]
  2. Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Proportion of Mirena users who have menstrual disorders [ Time Frame: 12 months ]
  2. Proportion of Mirena users with menorrhagia [ Time Frame: 12 months ]
  3. Cumulative rate of satisfaction in Mirena users [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833793


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01833793     History of Changes
Other Study ID Numbers: 16314
MA1211DZ ( Other Identifier: Company internal )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

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
Contraceptives, Oral, Synthetic
Contraceptives, Oral