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

NCT01200186 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3258

Last updated 2015-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Contraceptives, Oral

Interventions

DRUG

EV/DNG (Qlaira, BAY86-5027)

At the discretion of the attending physician

DRUG

Progestin Only Pills

At the discretion of the attending physician

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-02-28
Completion
2014-10-31

Countries

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

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200186 on ClinicalTrials.gov