ContraceptionPhase 3NCT00185354
FC Patch Comparator Study
A Phase 3 study testing BAY86-5016, SH P00331F and SH P00331N in people with Contraception, run by Bayer at 28 sites in 4 countries.
Trial summary
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator. 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?
- BAY86-5016, SH P00331F and SH P00331N
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 28 sitesin 4 countries
- Study dates
- Nov 2004to Apr 2006
- 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 female volunteer aged 18-35, smokers 18-30
Who cannot join
- Contraindications for using hormonal contraceptives
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
France12 sites
Study site
Biarritz, 64200
Study site
Bordeaux, 33000
Study site
Compiègne, 60200
Study site
Compiègne, 60204
Study site
Maisons Lafitte, 78600
Study site
Montargis, 45200
Study site
Nancy, 54042
Study site
Pantin, 93500
Study site
Paris, Paris, 75018
Study site
Roanne, 42300
Study site
Saint-Germain-en-Laye, 78100
Study site
Toulouse, 31500
Austria6 sites
Study site
Bregenz, 6900
Study site
Graz, 8010
Study site
Vienna, 1030
Study site
Vienna, 1090
Study site
Wörgl, Tyrol, 6300
Study site
Zeltweg, 8740
Spain6 sites
Study site
Barcelona, 08006
Study site
Guadalajara, Guadalajara, 19002
Study site
Pontevedra, Galicia, 36002
Study site
Salt, Girona, 17190
Study site
San Fernando, Cádiz, 11100
Study site
Santiago de Compostela, 15701
Finland4 sites
Study site
Helsinki, 00100
Study site
Helsinki, 00180
Study site
Turku, 20100
Study site
Turku, 20541
About this study
Official title: Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Contraception
- Being tested
- BAY86-5016, SH P00331F, SH P00331N
- Keywords
- FC patch, comparator study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-5016, SH P00331FDrug
Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)
SH P00331NDrug
Drug amount per patch: 0.6 mg EE2 + 6 mg NGM
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY86-5016, SH P00331F |
| Arm 2 | Active comparator | Not described Receives: Drug: SH P00331N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding pattern and cycle control
Measured: 13 cycles
Number of pregnancies
Measured: 13 cycles
Secondary outcomes (3)
Adverse events collection
Measured: 13 cycles
Endometrial biopsy
Measured: 13 cycles
Physical and gynecological exam
Measured: 13 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionApr 2006
- Study completionApr 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 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
- NCT00185354
- Sponsor's protocol ID
- 91402
- Other IDs
- 2004-000821-31, 307969, 2004
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2005
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00185354
- Acronym / sponsor ID
- 91402
- Conditions
- Contraception
- Keywords
- FC patch, comparator study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 2005 (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 purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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: BAY86-5016, SH P00331F |
| Arm 2 | Active comparator | Drug: SH P00331N |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy female volunteer aged 18-35, smokers 18-30
Key exclusion criteria (1 listed)
- Contraindications for using hormonal contraceptives
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 |
|---|---|---|
| BAY86-5016, SH P00331FDrug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD) | Drug | Arm 1 |
| SH P00331NDrug amount per patch: 0.6 mg EE2 + 6 mg NGM | Drug | Arm 2 |
Primary outcome
Bleeding pattern and cycle control
Time frame: 13 cycles
Number of pregnancies
Time frame: 13 cycles
3 secondary outcomes
Adverse events collection
Time frame: 13 cycles
Endometrial biopsy
Time frame: 13 cycles
Physical and gynecological exam
Time frame: 13 cycles
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 31 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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
28 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BAY86-5016, SH P00331F and SH P00331N in people with Contraception, run by Bayer at 28 sites in 4 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 1 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: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Austria, Spain, Finland. 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 pattern and cycle control (time frame: 13 cycles). The study lists 2 primary outcomes in all. 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 31 Dec 2015.