ContraceptionPhase 3NCT00984789
Birth Control Patch Study
A Phase 3 study testing Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) and Norelgestromin/Ethinylestradiol (EVRA) in people with Contraception, run by Bayer at 23 sites in 3 countries.
Trial summary
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) and Norelgestromin/Ethinylestradiol (EVRA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 23 sitesin 3 countries
- Study dates
- May 2009to Sep 2010
- Phase
- Phase 3
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women requesting contraception aged 18-35 years old
- Smokers must not be older than 30 at time of informed consent
- History of regular cyclic menstrual periods, normal cervical smear
Who cannot join
- Pregnancy or lactation
- Obesity (BMI>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
Austria10 sites
Study site
Bregenz, Vorarlberg, 6900
Study site
Graz, Styria, 8036
Study site
Graz, 8010
Study site
Innsbruck, 6020
Study site
Mödling, Lower Austria, 2340
Study site
Vienna, 1050
Study site
Vienna, 1090
Study site
Wiener Neustadt, Lower Austria, 2700
Study site
Wörgl, Tyrol, 6300
Study site
Zeltweg, 8740
Czechia9 sites
Study site
Brno, 602 00
Study site
České Budějovice, 37001
Study site
Hradec Králové, 500 02
Study site
Olomouc, 77900
Study site
Písek, 39701
Study site
Prague, 109 00
Study site
Prague, 120 00
Study site
Prague, 13000
Study site
Prague, 170 00
Netherlands4 sites
Study site
De Bilt, 3731 DN
Study site
Den Helder, 1782 GZ
Study site
Heerlen, 6401 MB
Study site
Nijmegen, 6525 EC
About this study
Official title: Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.
- Conditions
- Contraception
- Being tested
- Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016), Norelgestromin/Ethinylestradiol (EVRA)
- Keywords
- Transdermal Patch, Bleeding, Pregnancy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)Drug
0.55mg ethinylestradiol and 2.1mg gestodene
Norelgestromin/Ethinylestradiol (EVRA)Drug
0.6mg ethinylestradiol and 6mg norelgestromin
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) |
| Arm 2 | Active comparator | Not described Receives: Drug: Norelgestromin/Ethinylestradiol (EVRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Patterns and cycle control
Measured: 7 cycles (each consisting of 28 days)
Secondary outcomes (5)
Contraceptive efficacy
Measured: 7 cycles (each consisting of 28 days) + follow up period of 14 days
Adverse Event Collection
Measured: 7 cycles (each consisting of 28 days)
Population pharmacokinetics
Measured: 7 cycles (each consisting of 28 days)
Compliance to treatment
Measured: 7 cycles (each consisting of 28 days)
Subjective assessment of treatment
Measured: 7 cycles (each consisting of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984789
- Sponsor's protocol ID
- 13082
- Other IDs
- 2008-007308-27, 2008
- Status last verified
- Apr 2014
- First submitted
- 4 Sep 2009
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.
PubMed 25453582
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Contraception Patch: EU Cycle Control Study Versus EVRA
- ClinicalTrials.gov ID
- NCT00984789
- Acronym / sponsor ID
- 13082
- Conditions
- Contraception
- Keywords
- Transdermal Patch, Bleeding, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Sep 2009 (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.
400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) |
| Arm 2 | Active comparator | Drug: Norelgestromin/Ethinylestradiol (EVRA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women requesting contraception aged 18-35 years old
- Smokers must not be older than 30 at time of informed consent
- History of regular cyclic menstrual periods, normal cervical smear
Key exclusion criteria (2 listed)
- Pregnancy or lactation
- Obesity (BMI>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016)0.55mg ethinylestradiol and 2.1mg gestodene | Drug | Arm 1 |
| Norelgestromin/Ethinylestradiol (EVRA)0.6mg ethinylestradiol and 6mg norelgestromin | Drug | Arm 2 |
Primary outcome
Bleeding Patterns and cycle control
Time frame: 7 cycles (each consisting of 28 days)
5 secondary outcomes
Contraceptive efficacy
Time frame: 7 cycles (each consisting of 28 days) + follow up period of 14 days
Adverse Event Collection
Time frame: 7 cycles (each consisting of 28 days)
Population pharmacokinetics
Time frame: 7 cycles (each consisting of 28 days)
Compliance to treatment
Time frame: 7 cycles (each consisting of 28 days)
Subjective assessment of treatment
Time frame: 7 cycles (each consisting of 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Derived from this study: PubMed 25453582Gruber D, Skrivanek A, Serrani M, Lanius V, Merz M. A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study. Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.
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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.
Bayer Study Director study director
Bayer
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethinylestradiol/Gestodene (FC Patch Low BAY86-5016) and Norelgestromin/Ethinylestradiol (EVRA) in people with Contraception, run by Bayer at 23 sites in 3 countries.
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 2 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: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Austria, Czechia, Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding Patterns and cycle control (time frame: 7 cycles (each consisting of 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984789, which also lists 1 linked publication.
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 2 Apr 2014.