ContraceptionPhase 3NCT00920985
US Cycle Control and Blood Pressure Study
A Phase 3 study testing Gestodene/EE (FC Patch Low, BAY86-5016) and Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A in people with Contraception, run by Bayer at 28 sites in United States.
Trial summary
Birth Control Patch Study Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Gestodene/EE (FC Patch Low, BAY86-5016) and Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 28 sitesUnited States
- Study dates
- Jun 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subject requesting contraception
- Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- History of regular cyclic menstrual periods
Who cannot join
- Pregnancy or lactation
- 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
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Study site
Anaheim, California, 92801
Study site
Atlanta, Georgia, 30342
Study site
Chandler, Arizona, 85225-2909
Study site
Cincinnati, Ohio, 45246
Study site
Clearwater, Florida, 33759
Study site
Columbia, South Carolina, 29201
Study site
Daytona Beach, Florida, 32114
Study site
Decatur, Georgia, 30034
Study site
Glendale, Arizona, 85304
Study site
Kalamazoo, Michigan, 49009
Study site
La Crosse, Wisconsin, 54691
Study site
Lake Worth, Florida, 33461
Study site
Las Vegas, Nevada, 89104
Study site
Leesburg, Florida, 34748
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33169
Study site
New Brunswick, New Jersey, 08901
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85032
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Renton, Washington, 98055
Study site
Richmond, Virginia, 23294
Study site
San Diego, California, 92121
Study site
Seattle, Washington, 98105
Study site
St Louis, Missouri, 63141
Study site
Tucson, Arizona, 85712
Study site
Wexford, Pennsylvania, 15090
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
Birth Control Patch Study
- Conditions
- Contraception
- Being tested
- Gestodene/EE (FC Patch Low, BAY86-5016), Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
- Keywords
- Pregnancy prevention, Female contraception, Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestodene/EE (FC Patch Low, BAY86-5016)Drug
21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2
Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593ADrug
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gestodene/EE (FC Patch Low, BAY86-5016) |
| Arm 2 | Active comparator | Not described Receives: Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycle control parameters and bleeding pattern indices
Measured: Treatment cycles 2-7
Secondary outcomes (2)
Number of pregnancies while on treatment up to 14 days after removal of the last patch
Measured: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval
Measured: 7 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 posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 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
- NCT00920985
- Sponsor's protocol ID
- 91556
- Status last verified
- Jan 2014
- First submitted
- 15 Jun 2009
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Merz M, Kroll R, Lynen R, Bangerter K. Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study. Contraception. 2015 Feb;91(2):113-20. doi: 10.1016/j.contraception.2014.10.004. Epub 2014 Oct 13.
PubMed 25453585
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women
- ClinicalTrials.gov ID
- NCT00920985
- Acronym / sponsor ID
- 91556
- Conditions
- Contraception
- Keywords
- Pregnancy prevention, Female contraception, Patch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 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.
Birth Control Patch Study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gestodene/EE (FC Patch Low, BAY86-5016) |
| Arm 2 | Active comparator | Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female subject requesting contraception
- Age: 18 - 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
- History of regular cyclic menstrual periods
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- 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 |
|---|---|---|
| Gestodene/EE (FC Patch Low, BAY86-5016)21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2 | Drug | Arm 1 |
| Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1 | Drug | Arm 2 |
Primary outcome
Cycle control parameters and bleeding pattern indices
Time frame: Treatment cycles 2-7
2 secondary outcomes
Number of pregnancies while on treatment up to 14 days after removal of the last patch
Time frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval
Time frame: 7 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 9 Oct 2015.
- Derived from this study: PubMed 25453585Merz M, Kroll R, Lynen R, Bangerter K. Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study. Contraception. 2015 Feb;91(2):113-20. doi: 10.1016/j.contraception.2014.10.004. 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
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gestodene/EE (FC Patch Low, BAY86-5016) and Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A in people with Contraception, run by Bayer at 28 sites in United States.
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 4 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 9 Oct 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 United States. 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?
Cycle control parameters and bleeding pattern indices (time frame: Treatment cycles 2-7). 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 NCT00920985, 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 9 Oct 2015.