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MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study (MIDAS)

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ClinicalTrials.gov Identifier: NCT01961375
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Condition or disease Intervention/treatment
Contraception Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
Actual Study Start Date : November 30, 2015
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Group 1
BAY 86-5028; Levonorgestrel- Intra Uterine System
Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion



Primary Outcome Measures :
  1. Percentage continuation rate of LNG IUS at end of observation period. [ Time Frame: 12 months ]
  2. Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cumulative discontinuation rate for pregnancy [ Time Frame: 12 months ]
  2. Cumulative discontinuation rate for other medical reasons [ Time Frame: 12 months ]
  3. Cumulative discontinuation rate for non-medical reasons [ Time Frame: 12 months ]
  4. Mean percentage of women with amenorrhea [ Time Frame: 12 months ]
  5. Mean percent of women with spotting, inter-menstrual bleeding [ Time Frame: 12 months ]
  6. Distribution of contraceptive usage patterns [ Time Frame: 12 months ]
    contraceptive usage patterns included:birth-spacing, long term contraception, postpartum contraception, post-abortion contraception, switch from other method, contraception for other medical reasons like heart disease, etc

  7. Incidence rate of drug-related adverse events [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study subjects will be enrolled from multiple sites like women's hospitals, tertiary care institutes, Family planning clinics and gynaecological consulting centres.
Criteria

Inclusion Criteria:

  • Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
  • Subject willing to provide informed consent and comply with study procedure.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.

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): NCT01961375


Contacts
Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com

Locations
India
Recruiting
Multiple Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01961375     History of Changes
Other Study ID Numbers: 16199
MA1210IN ( Other Identifier: company internal )
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral