DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena) (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

Official title: MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Percentage continuation rate of LNG IUS at end of observation period.

Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied

Secondary outcome:

Cumulative discontinuation rate for pregnancy

Cumulative discontinuation rate for other medical reasons

Cumulative discontinuation rate for non-medical reasons

Mean percentage of women with amenorrhea

Mean percent of women with spotting, inter-menstrual bleeding

Distribution of contraceptive usage patterns

Incidence rate of drug-related adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

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

Locations and Contacts

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

Many Locations, India; Not yet recruiting
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: September 2015
Last updated: August 3, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017