ContraceptionPhase 3NCT00914693
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
A Phase 3 study testing Ethinylestradiol/Gestodene (BAY86-5016) in people with Contraception, run by Bayer at 66 sites in 8 countries.
Trial summary
The aim of the present study is to prove efficacy and safety of a new contraceptive patch. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Ethinylestradiol/Gestodene (BAY86-5016)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,694 participants
- Where
- 66 sitesin 8 countries
- Study dates
- Apr 2009to Sep 2011
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
Who cannot join
- Pregnancy or lactation
- Obesity (BMI> 30 kg/m2
- Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- Use of other contraceptive methods than study medication
Trial locations and contacts
66 sites in 8 countries.
66 sites in 8 countries
Germany16 sites
Study site
Aachen, North Rhine-Westphalia, 52072
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 12587
Study site
Berlin, State of Berlin, 13507
Study site
Blankenburg, Saxony-Anhalt, 38889
Study site
Cologne, North Rhine-Westphalia, 50924
Study site
Dippoldiswalde, Saxony, 01744
Study site
Dresden, Saxony, 01099
Study site
Frankfurt am Main, Hesse, 60590
Study site
Gera, Thuringia, 07545
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Leipzig, Saxony, 04207
Study site
Leipzig, Saxony, 04299
Study site
Magdeburg, Saxony-Anhalt, 39104
Study site
Siegen, North Rhine-Westphalia, 57072
Study site
Wuppertal, North Rhine-Westphalia, 42103
Italy11 sites
Study site
Bologna, 40138
Study site
Cagliari, 09124
Study site
Catanzaro, 88100
Study site
Florence, 50134
Study site
Francavilla Fontana, Brindisi, 72021
Study site
Modena, 41124
Study site
Palermo, 90127
Study site
Pavia, 27100
Study site
Perugia, 06156
Study site
Pisa, 56126
Study site
Siena, 53100
Spain10 sites
Study site
Alava, Vitoria, 01004
Study site
Barcelona, Barcelona, 08013
Study site
Barcelona, Barcelona, 08028
Study site
Barcelona, 08035
Study site
Dos Hermanas, Sevilla, 41700
Study site
Lugo, Lugo, 27002
Study site
Pamplona, Pamplona, 31015
Study site
San Fernando, Cádiz, 11100
Study site
Vigo, Pontevedra, 36209
Study site
Zaragoza, Zaragoza, 50001
France7 sites
Study site
Biarritz, 64200
Study site
Montargis, 45200
Study site
Nîmes, 30029
Study site
Quetigny, 21800
Study site
Reims, 51092
Study site
Saint-Germain-en-Laye, 78100
Study site
Toulouse, 31000
Argentina6 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC
Study site
Lanús Oeste, Buenos Aires, 1824
Study site
Rosario, Santa Fe Province, 2000
Study site
San Isidro, Buenos Aires, B1642CLN
Mexico6 sites
Study site
Chihuahua City, Chihuahua, 31350
Study site
Mexico City, 11000
Study site
México D.F., 10700
Study site
México, D.F., 11000
Study site
San Luis Potosí City, San Luis Potosí, 78230
Study site
Torreón, Coahuila, 27000
Australia5 sites
Study site
Adelaide, South Australia, 5000
Study site
Ashfield, New South Wales, 2031
Study site
Clayton, Victoria, 3168
Study site
Nedlands, Western Australia, 6009
Study site
North Adelaide, South Australia, 5006
Chile5 sites
Study site
Santiago, Santiago Metropolitan, 7510025
Study site
Santiago, Santiago Metropolitan, 8350488
Study site
Santiago, 8320165
Study site
Temuco, Araucania, 4791348
Study site
Temuco, 4790711
About this study
Official title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
- Conditions
- Contraception
- Being tested
- Ethinylestradiol/Gestodene (BAY86-5016)
- Keywords
- Fertility control, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinylestradiol/Gestodene (BAY86-5016)Drug
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Ethinylestradiol/Gestodene (BAY86-5016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pregnancy
Measured: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
Secondary outcomes (3)
Cervical smear
Measured: 13 treatment cycles each consisting of 28 days
Adverse events
Measured: 13 treatment cycles each consisting of 28 days
Bleeding pattern and cycle control
Measured: 13 treatment 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 posted5 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914693
- Sponsor's protocol ID
- 91554
- Other IDs
- 2008-004214-27, 310801, 2008
- Status last verified
- Dec 2014
- First submitted
- 5 May 2009
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00914693
- Acronym / sponsor ID
- 91554
- Conditions
- Contraception
- Keywords
- Fertility control, Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,694 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Jun 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.
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Ethinylestradiol/Gestodene (BAY86-5016) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Requiring contraception
- Normal cervical smear
- Smokers not older than 30 years
- History of regular cyclic menstrual periods
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Obesity (BMI> 30 kg/m2
- Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
- Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
- Use of other contraceptive methods than study medication
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 (BAY86-5016)7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen | Drug | Arm 1 |
Primary outcome
Occurrence of pregnancy
Time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days
3 secondary outcomes
Cervical smear
Time frame: 13 treatment cycles each consisting of 28 days
Adverse events
Time frame: 13 treatment cycles each consisting of 28 days
Bleeding pattern and cycle control
Time frame: 13 treatment 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 5 Dec 2014.
- Click here and search for Bayer Product information provided by EMALink provided by the sponsor.
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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
66 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethinylestradiol/Gestodene (BAY86-5016) in people with Contraception, run by Bayer at 66 sites in 8 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 4 inclusion and 5 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Germany, Italy, Spain, France, Argentina and 3 more countries. 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?
Occurrence of pregnancy (time frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days). 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 5 Dec 2014.