Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

October 15, 2015 updated by: Bayer
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in gynecological practice

Description

Inclusion Criteria:

  • Women between 18-50 years
  • Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
  • Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented

Exclusion Criteria:

  • Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
  • Women who are breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: EV/DNG (Qlaira, BAY86-5027)
At the discretion of the attending physician
Group 2
Drug: Progestin Only Pills
At the discretion of the attending physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
Time Frame: up to 12 Months
up to 12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to event for discontinuation due to reasons other than bleeding irregularities
Time Frame: Month 3-5
Month 3-5
Time to event for discontinuation due to reasons other than bleeding irregularities
Time Frame: Month 6-12
Month 6-12
Number of intracyclic bleeding
Time Frame: Month 3-5
Month 3-5
Number of intracyclic bleeding
Time Frame: Month 6-12
Month 6-12
Number of heavy and/or prolonged bleeding
Time Frame: Month 3-5
Month 3-5
Number of heavy and/or prolonged bleeding
Time Frame: Month 6-12
Month 6-12
Number of unintended pregnancies
Time Frame: Month 3-5
Month 3-5
Number of unintended pregnancies
Time Frame: Month 6-12
Month 6-12
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Time Frame: Month 3-5
Month 3-5
Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons
Time Frame: Month 6-12
Month 6-12
Global assessment of well-being and satisfaction
Time Frame: Month 3-5
Month 3-5
Global assessment of well-being and satisfaction
Time Frame: Month 6-12
Month 6-12
Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy
Time Frame: up to 12 Months
up to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

August 13, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (ESTIMATE)

September 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15217
  • QL0901 (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraceptives, Oral

Clinical Trials on EV/DNG (Qlaira, BAY86-5027)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe