NCT01961375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 30, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

October 10, 2013

Last Update Submit

October 12, 2023

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

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

    12 months

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

    12 months

Secondary Outcomes (7)

  • Cumulative discontinuation rate for pregnancy

    12 months

  • Cumulative discontinuation rate for other medical reasons

    12 months

  • Cumulative discontinuation rate for non-medical reasons

    12 months

  • Mean percentage of women with amenorrhea

    12 months

  • Mean percent of women with spotting, inter-menstrual bleeding

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Group 1

BAY 86-5028; Levonorgestrel- Intra Uterine System

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

Interventions

Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)DRUG

Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion

Group 1

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, India

Location

Related Links

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 11, 2013

Study Start

October 30, 2015

Primary Completion

November 28, 2018

Study Completion

September 21, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

IN(1)