NCT01200186|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Company Internal
observational
3,258
11 countries
11
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 13, 2010
Actual (reported)September 13, 2010
Actual (reported)October 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Actual (reported)October 2014
Actual (reported)The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
up to 12 Months
Time to event for discontinuation due to reasons other than bleeding irregularities
Month 3-5
Time to event for discontinuation due to reasons other than bleeding irregularities
Month 6-12
Number of intracyclic bleeding
Month 3-5
Number of intracyclic bleeding
Month 6-12
Number of heavy and/or prolonged bleeding
Month 3-5
At the discretion of the attending physician
At the discretion of the attending physician
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women in gynecological practice
Many Locations, Czechia
Many Locations, France
Many Locations, Germany
Many Locations, Greece
Many Locations, Hungary
Many Locations, Israel
Many Locations, Italy
Many Locations, Russia
Bayer Study Director
Bayer
3,258 participants (actual enrollment reported by the registry).
First Submitted
August 13, 2010
First Posted
September 13, 2010
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Contact the study team to confirm eligibility.
Many Locations, Slovakia
Many Locations, Sweden
Many Locations, United Kingdom
Primary Completion
February 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
October 16, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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