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

NCT ID: NCT01200186

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraceptives, Oral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

EV/DNG (Qlaira, BAY86-5027)

Intervention Type DRUG

At the discretion of the attending physician

Group 2

Progestin Only Pills

Intervention Type DRUG

At the discretion of the attending physician

Interventions

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EV/DNG (Qlaira, BAY86-5027)

At the discretion of the attending physician

Intervention Type DRUG

Progestin Only Pills

At the discretion of the attending physician

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Czechia

Site Status

Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Greece

Site Status

Many Locations, , Hungary

Site Status

Many Locations, , Israel

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Russia

Site Status

Many Locations, , Slovakia

Site Status

Many Locations, , Sweden

Site Status

Many Locations, , United Kingdom

Site Status

Countries

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Czechia France Germany Greece Hungary Israel Italy Russia Slovakia Sweden United Kingdom

Other Identifiers

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QL0901

Identifier Type: OTHER

Identifier Source: secondary_id

15217

Identifier Type: -

Identifier Source: org_study_id

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