NCT02577913

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,281

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

October 15, 2015

Last Update Submit

November 17, 2020

Conditions

Contraception

Keywords

contraceptioncontraceptive patchLevonorgestrelgestodenesafety

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism

    Deep venous thromboembolism

    24 months

Secondary Outcomes (4)

  • Arterial thromboembolism

    24 months

  • Application site reactions

    24 months

  • Short- and long-term fertility

    24 months

  • Pregnancy outcomes

    24 months

Study Arms (2)

FC patch low

Women taking FC Patch low, a transdermal patch releasing 60 micrograms gestodene/24 hours + 13 micrograms ethinyl estradiol/24 hours

LNG-COC

Women taking levonorgestrel-containing COCs: 1) monophasic preparations containing 20 - 30mcg of ethinylestradiol; 2) multiphasic preparations containing up to 40mcg of ethinylestradiol

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women using combined hormonal contraceptives

You may not qualify if:

  • First ever user of a combined hormonal contraceptive "starter"
  • User who restarts a combined hormonal contraceptive after at leat a two month break "restarter"
  • Women willing to participate in an active surveillance study
  • \- Women who do not understand the major aspects of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berlin Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Study Officials

  • Klaas Heinemann, MD PhD MBA

    ZEG Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Klaas Heinemann, MD PhD MBA

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 16, 2015

Study Start

November 1, 2015

Primary Completion

January 31, 2017

Study Completion

May 22, 2019

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

DE(1)