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

This study is currently recruiting participants.
Verified October 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01961375
First Posted: October 11, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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 Intervention
Contraception Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Cumulative discontinuation rate for pregnancy [ Time Frame: 12 months ]
  • Cumulative discontinuation rate for other medical reasons [ Time Frame: 12 months ]
  • Cumulative discontinuation rate for non-medical reasons [ Time Frame: 12 months ]
  • Mean percentage of women with amenorrhea [ Time Frame: 12 months ]
  • Mean percent of women with spotting, inter-menstrual bleeding [ Time Frame: 12 months ]
  • 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

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

Estimated Enrollment: 600
Actual Study Start Date: November 30, 2015
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: October 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01961375     History of Changes
Other Study ID Numbers: 16199
MA1210IN ( Other Identifier: company internal )
First Submitted: October 10, 2013
First Posted: October 11, 2013
Last Update Posted: October 23, 2017
Last Verified: October 2017

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