ContraceptionEURAS-CORANCT02577913
European Active Surveillance Study Comparing Regimens of Administration in Combined Hormonal Contraception
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 2,281 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to 22 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women using combined hormonal contraceptives
Who may be able to join
- 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
Who cannot join
- Women who do not understand the major aspects of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berlin Center for Epidemiology and Health Research
Berlin, 10115
About this study
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.
Read the detailed description
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. The most relevant adverse clinical outcome that has been linked to the use of COCs is venous thromboembolism (VTE). Data from randomized clinical trials did not show any serious health concerns for FC Patch Low. However, the statistical power to detect rare adverse events is limited in these studies.
EURAS-CORA is a large, prospective, controlled, long-term active surveillance study to investigate the safety of FC Patch Low with regard to the outcomes of interest. This study follows the European Active Surveillance (EURAS) design methodology with some modifications due to country- and product-specific characteristics. The outcomes of interest will be validated via the attending physicians. A multi-faceted follow-up procedure will ensure a low loss to follow-up rate. This study will involve women from Europe who will be followed for up to 2 years. Data analysis will include multivariable techniques such as Cox regression.
The study has been terminated:
On 10th October, 2016 Gedeon Richter Plc initiated a recall of the FC Patch Low based on stability data provided by Bayer AG (licensor). Under certain conditions the stability tests showed out of specification results. Data from in vitro dissolution tests have shown altered dissolution profile for the gestodene component. Furthermore, visually observable quality defect of crystallization due to the progesterone component (gestodene) had been detected. The clinical relevance of the quality issue is currently not proven. Based on the company's safety database, no increase in the frequency of reported adverse events or in the number of unwanted pregnancies were observed in association with the quality issue of the patch. The Pearl Index calculated based on this post-marketing data and taking into account the possible under-reporting (Pearl Index: 0.50) is considerably lower than the Pearl Index based on the data from clinical trials (Pearl Index: 1.19).
The competent authorities were informed about the quality issue and Gedeon Richter Plc took the precautionary measure to stop marketing and commercializing the product. Wholesale partners were asked to recall the affected product batches currently on the market from pharmacies.
Study investigators were officially informed of the recall and study suspension on 17th October, 2016. The suspension of network expansion activities in Spain and France was immediate. Physician recruitment in Italy had not formally commenced at the time of the study suspension. All relevant ethics committees, including the EMA PAS register, were informed of the study suspension by 21st October, 2016. The maximum duration of contraceptive use for current FC Patch Low users is 10th October 2016 + 3months (or 10th January 2017). Therefore, all women currently enrolled in EURAS-CORA were followed up until January 2017.
On 22nd May 2019, ZEG Berlin were officially notified by Gedeon Richter Plc that FC Patch Low had been withdrawn from the European market.
- Conditions
- Contraception
- Keywords
- contraception, contraceptive patch, Levonorgestrel, gestodene, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism
Deep venous thromboembolism
Measured: 24 months
Secondary outcomes (4)
Arterial thromboembolism
Acute myocardial infarction, cerebrovascular accident, other arterial thromboembolism
Measured: 24 months
Application site reactions
Monitoring of potential skin reactions at the site of Lisvy patch administration
Measured: 24 months
Short- and long-term fertility
return to fertility outcomes after stopping patch use
Measured: 24 months
Pregnancy outcomes
unintended pregnancies during contraceptive use
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion31 Jan 2017
- Study completion22 May 2019
Why it stopped: MA of product has been withdrawn from the European market due to stability data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Gedeon Richter Plc.
- Responsible party
- Principal investigator, Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany
- Investigators
- Klaas Heinemann, MD PhD MBA, Principal investigator, ZEG Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577913
- Sponsor's protocol ID
- ZEG2014_03
- Acronym
- EURAS-CORA
- Status last verified
- Nov 2020
- First submitted
- 15 Oct 2015
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Active Surveillance Study Comparing Regimens of Administration in Combined Hormonal Contraception
- ClinicalTrials.gov ID
- NCT02577913
- Acronym / sponsor ID
- EURAS-CORA / ZEG2014_03
- Conditions
- Contraception
- Keywords
- contraception, contraceptive patch, Levonorgestrel, gestodene, safety
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: MA of product has been withdrawn from the European market due to stability data
- Enrolment
- 2,281 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Gedeon Richter Plc.
- Study start
- Nov 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The most relevant adverse clinical outcome that has been linked to the use of COCs is venous thromboembolism (VTE). Data from randomized clinical trials did not show any serious health concerns for FC Patch Low. However, the statistical power to detect rare adverse events is limited in these studies.
EURAS-CORA is a large, prospective, controlled, long-term active surveillance study to investigate the safety of FC Patch Low with regard to the outcomes of interest. This study follows the European Active Surveillance (EURAS) design methodology with some modifications due to country- and product-specific characteristics. The outcomes of interest will be validated via the attending physicians. A multi-faceted follow-up procedure will ensure a low loss to follow-up rate. This study will involve women from Europe who will be followed for up to 2 years. Data analysis will include multivariable techniques such as Cox regression.
The study has been terminated:
On 10th October, 2016 Gedeon Richter Plc initiated a recall of the FC Patch Low based on stability data provided by Bayer AG (licensor). Under certain conditions the stability tests showed out of specification results. Data from in vitro dissolution tests have shown altered dissolution profile for the gestodene component. Furthermore, visually observable quality defect of crystallization due to the progesterone component (gestodene) had been detected. The clinical relevance of the quality issue is currently not proven. Based on the company's safety database, no increase in the frequency of reported adverse events or in the number of unwanted pregnancies were observed in association with the quality issue of the patch. The Pearl Index calculated based on this post-marketing data and taking into account the possible under-reporting (Pearl Index: 0.50) is considerably lower than the Pearl Index based on the data from clinical trials (Pearl Index: 1.19).
The competent authorities were informed about the quality issue and Gedeon Richter Plc took the precautionary measure to stop marketing and commercializing the product. Wholesale partners were asked to recall the affected product batches currently on the market from pharmacies.
Study investigators were officially informed of the recall and study suspension on 17th October, 2016. The suspension of network expansion activities in Spain and France was immediate. Physician recruitment in Italy had not formally commenced at the time of the study suspension. All relevant ethics committees, including the EMA PAS register, were informed of the study suspension by 21st October, 2016. The maximum duration of contraceptive use for current FC Patch Low users is 10th October 2016 + 3months (or 10th January 2017). Therefore, all women currently enrolled in EURAS-CORA were followed up until January 2017.
On 22nd May 2019, ZEG Berlin were officially notified by Gedeon Richter Plc that FC Patch Low had been withdrawn from the European market.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women using combined hormonal contraceptives
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Women who do not understand the major aspects of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous thromboembolism
Time frame: 24 months
Deep venous thromboembolism
4 secondary outcomes
Arterial thromboembolism
Time frame: 24 months
Application site reactions
Time frame: 24 months
Short- and long-term fertility
Time frame: 24 months
Pregnancy outcomes
Time frame: 24 months
Results and safety
The study was stopped early (reason given: MA of product has been withdrawn from the European market due to stability data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas Heinemann, MD PhD MBA principal investigator
ZEG Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: MA of product has been withdrawn from the European market due to stability data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.