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European Active Surveillance Study Comparing Regimens of Administration in Combined Hormonal Contraception

NCT02577913 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2281

Last updated 2020-11-18

No results posted yet for this study

Summary

This study compares the risks of short- and long-term use of FC Patch Low with levonorgestrel-containing combined oral contraceptives (COC-LNG) in a study population representative of the actual users of the individual preparations. FC Patch Low is a transdermal contraceptive patch applied once a week for three consecutive weeks followed by a break of one week (21/7). One patch contains 2.1mg gestodene and 0.55mg ethinyl estradiol, which is equivalent of releasing 0.06mg gestodene and 0.013mg ethinyl estradiol per 24 hours.

Conditions

  • Contraception

Sponsors & Collaborators

  • Gedeon Richter Plc.

    collaborator INDUSTRY

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Principal Investigators

  • Klaas Heinemann, MD PhD MBA · ZEG Berlin

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-01-31
Completion
2019-05-22

Countries

  • Germany

Study Locations

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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 NCT02577913 on ClinicalTrials.gov