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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01961375
First received: October 10, 2013
Last updated: August 26, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]
  • Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative discontinuation rate for pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for other medical reasons [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for non-medical reasons [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean percentage of women with amenorrhea [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean percent of women with spotting, inter-menstrual bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Distribution of contraceptive usage patterns [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: October 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: October 2016 (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

Ages Eligible for Study:   18 Years to 49 Years
Genders 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
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: NCT01961375

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
India
Not yet recruiting
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01961375     History of Changes
Other Study ID Numbers: 16199, MA1210IN
Study First Received: October 10, 2013
Last Updated: August 26, 2014
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
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 August 27, 2014