ContraceptionPhase 3ATI-CL13NCT01236768
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
A Phase 3 study testing AG200-15 and Levora in people with Contraception, run by Agile Therapeutics at 21 sites in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- AG200-15 and Levora
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sexually active women requesting contraception
- Regular menses every 24 - 35 days
- In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values
Who cannot join
- Known or suspected pregnancy
- Lactating women
- 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
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Boynton Beach, Florida, 33472
Study site
Corpus Christi, Texas, 78414
Study site
Englewood, Ohio, 45322
Study site
Green Valley, Arizona, 85614
Study site
Kernersville, North Carolina, 27284
Study site
Las Vegas, Nevada, 89109
Study site
Las Vegas, Nevada, 89128
Study site
Los Angeles, California, 90036
Study site
Los Angeles, California, 90057
Study site
Louisville, Kentucky, 40291
Study site
Mobile, Alabama, 36608
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Newburgh, Indiana, 47630
Study site
Newport News, Virginia, 23606
Study site
Norfolk, Virginia, 23502
Study site
South Miami, Florida, 33143
Study site
St. Petersburg, Florida, 33709
Study site
Sugar Land, Texas, 77479
Study site
Tucson, Arizona, 85712
Study site
Tulsa, Oklahoma, 74105
Study site
West Hills, California, 91307
About this study
Official title: An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
Read the detailed description
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).
- Conditions
- Contraception
- Being tested
- AG200-15, Levora
- Keywords
- Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG200-15Drug
Also called Transdermal contraceptive delivery system (TCDS)
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
LevoraDrug
Also called Hormonal oral contraceptive
One tablet of Levora will be taken each day for a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| AG200-15 | Experimental | Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) Receives: Drug: AG200-15 |
| Levora | Active comparator | oral contraceptive containing 150mcg of LNG and 30mcg of EE Receives: Drug: Levora |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Reported as Pearl Index
Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
Measured: 6 months
Secondary outcomes (1)
Safety
Adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie Foegh, MD, Study director, Agile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236768
- Sponsor's protocol ID
- ATI-CL13
- Acronym
- ATI-CL13
- Status last verified
- Aug 2017
- First submitted
- 5 Nov 2010
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
- ClinicalTrials.gov ID
- NCT01236768
- Acronym / sponsor ID
- ATI-CL13 / ATI-CL13
- Conditions
- Contraception
- Keywords
- Contraceptive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Agile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 15 Sep 2017
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 the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
Detailed description
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG200-15 | Experimental | Drug: AG200-15Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) |
| Levora | Active comparator | Drug: Levoraoral contraceptive containing 150mcg of LNG and 30mcg of EE |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- sexually active women requesting contraception
- Regular menses every 24 - 35 days
- In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values
Key exclusion criteria (5 listed)
- Known or suspected pregnancy
- Lactating women
- 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 |
|---|---|---|
| AG200-15Also: Transdermal contraceptive delivery system (TCDS)Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. | Drug | AG200-15 |
| LevoraAlso: Hormonal oral contraceptiveOne tablet of Levora will be taken each day for a 28 day cycle. | Drug | Levora |
Primary outcome
Pregnancy Reported as Pearl Index
Time frame: 6 months
Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.
1 secondary outcome
Safety
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marie Foegh, MD study director
Agile Therapeutics
21 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 AG200-15 and Levora in people with Contraception, run by Agile Therapeutics at 21 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 3 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Yes. Results are posted in the registry (first posted 15 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pregnancy Reported as Pearl Index (time frame: 6 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 15 Sep 2017.