ContraceptionPhase 3NCT01181479
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
A Phase 3 study testing AG200-15 (cycles 1-13) and Lessina crossover to AG200-15 in people with Contraception, run by Agile Therapeutics at 80 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 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- AG200-15 (cycles 1-13) and Lessina crossover to AG200-15
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,504 participants
- Where
- 80 sitesUnited States
- Study dates
- Aug 2010to Mar 2012
- 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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy females
- 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active women requesting birth control
- In good general health, confirmed by medical history, physical (including gynecologic) examination and 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
80 sites in 1 country.
80 sites in 1 country
United States80 sites
Agile Investigational Site
Akron, Ohio, 44311
Agile Investigational Site
Atlanta, Georgia, 30342
Agile Investigational Site
Austin, Texas, 78702
Agile Investigational Site
Bedford, Texas, 76022
Agile Investigational Site
Boulder, Colorado, 80302
Agile Investigational Site
Boynton Beach, Florida, 33472
Agile Investigational Site
Cary, North Carolina, 27518
Agile Investigational Site
Champaign, Illinois, 61820
Agile Investigational Site
Chandler, Arizona, 85224
Agile Investigational Site
Charlotte, North Carolina, 28209
Agile Investigational Site
Chicago, Illinois, 60654
Agile Investigational Site
Cincinnati, Ohio, 45267
Agile Investigational Site
Clearwater, Florida, 33759
Agile Investigational Site
Cleveland, Ohio, 44122
Agile Investigational Site
Colorado Springs, Colorado, 80907
Agile Investigational Site
Columbus, Ohio, 43213
Agile Investigational Site
Corpus Christi, Texas, 78414
Agile Investigational Site
Dallas, Texas, 75231
Agile Investigational Site
Daytona Beach, Florida, 32114
Agile Investigational Site
Decatur, Georgia, 30034
Agile Investigational Site
DeLand, Florida, 32720
Agile Investigational Site
Denver, Colorado, 80207
Agile Investigational Site
Edison, New Jersey, 08817
Agile Investigational Site
Englewood, Ohio, 45322
Agile Investigational Site
Fort Collins, Colorado, 80524
Agile Investigational Site
Fort Myers, Florida, 33916
Agile Investigational Site
Green Valley, Arizona, 85614
Agile Investigational Site
Houston, Texas, 77089
Agile Investigational Site
Huntsville, Alabama, 35801
Agile Investigational Site
Indianapolis, Indiana, 46250
Agile Investigational Site
Jackson, Tennessee, 38305
Agile Investigational Site
Jacksonville, Florida, 32207
Agile Investigational Site
Kernersville, North Carolina, 27284
Agile Investigational Site
Knoxville, Tennessee, 37920
Agile Investigational Site
La Mesa, California, 91942
Agile Investigational Site
Las Vegas, Nevada, 89106
Agile Investigational Site
Lawrenceville, New Jersey, 08648
Agile Investigational Site
Lexington, Kentucky, 40509
Agile Investigational Site
Lincoln, Nebraska, 68510
Agile Investigational Site
Little Rock, Arkansas, 72205
Agile Investigational Site
Los Angeles, California, 90057
Agile Investigational Site
Louisville, Kentucky, 40291
Agile Investigational Site
Marrero, Louisiana, 70072
Agile Investigational Site
Mayfield Heights, Ohio, 44124
Agile Investigational Site
Medford, Oregon, 97504
Agile Investigational Site
Memphis, Tennessee, 38120
Agile Investigational Site
Milford, Connecticut, 06460
Agile Investigational Site
Mobile, Alabama, 36608
Agile Investigational Site
New London, Connecticut, 06320
Agile Investigational Site
Newburgh, Indiana, 47630
Agile Investigational Site
Newport News, Virginia, 23606
Agile Investigational Site
Norfolk, Virginia, 23502
Agile Investigational Site
Oklahoma City, Oklahoma, 73112
Agile Investigational Site
Overland Park, Kansas, 66202
Agile Investigational Site
Pinellas Park, Florida, 33781
Agile Investigational Site
Raleigh, North Carolina, 27609
Agile Investigational Site
Richmond, Virginia, 23294
Agile Investigational Site
Rochester, New York, 14609
Agile Investigational
Sacramento, California, 95831
Agile Investigational Site
Salisbury, North Carolina, 28144
Agile Investigational Site
Salt Lake City, Utah, 84109
Agile Investigational Site
San Antonio, Texas, 78229
Agile Investigational Site
San Diego, California, 92103
Agile Investigational Site
Sandy Springs, Georgia, 30328
Agile Investigational Site
Santa Ana, California, 92705
Agile Investigational Site
Seattle, Washington, 98105
Agile Investigational Site
South Miami, Florida, 33143
Agile Investigational Site
St. Petersburg, Florida, 33709
Agile Investigational Site
Sugar Land, Texas, 77479
Agile Investigational Site
Tucson, Arizona, 85712
Agile Investigational Site
Tulsa, Oklahoma, 74105
Agile Investigational Site
Vista, California, 92083
Agile Investigational Site
Waterbury, Connecticut, 06708
Agile Investigational Site
Webster, Texas, 77598
Agile Investigational Site
West Hills, California, 91307
Agile Investigational Site
West Palm Beach, Florida, 33409
Agile Investigational Site
Wheat Ridge, Colorado, 80033
Agile Investigational Site
Wichita, Kansas, 67205
Agile Investigational Site
Wilmington, North Carolina, 28401
Agile Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
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, 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 (cycles 1-13), Lessina crossover to AG200-15
- Keywords
- Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG200-15 (cycles 1-13)Drug
Also called transdermal patch
AG200-15 containing ethinyl estradiol and levonorgestrel
Lessina crossover to AG200-15Drug
Also called hormonal oral contraception and transdermal patch
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| AG200-15 (cycles 1-13) | Experimental | AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug. Receives: Drug: AG200-15 (cycles 1-13) |
| Lessina crossover to AG200-15 | Active comparator | Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug. Receives: Drug: Lessina crossover to AG200-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Pregnancy outcomes was determine by measuring 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: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionMar 2012
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Garner, MD, MPH, Study director, Agile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181479
- Sponsor's protocol ID
- ATI-CL12
- Other IDs
- 57731
- Status last verified
- Jul 2018
- First submitted
- 12 Aug 2010
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
PubMed 25586864Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.
PubMed 25582984Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Rubin A, Foegh M. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.
PubMed 24402597
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.
- ClinicalTrials.gov ID
- NCT01181479
- Acronym / sponsor ID
- ATI-CL12
- Conditions
- Contraception
- Keywords
- Contraceptive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- Agile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 3 Jul 2018
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, 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 (cycles 1-13) | Experimental | Drug: AG200-15 (cycles 1-13)AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug. |
| Lessina crossover to AG200-15 | Active comparator | Drug: Lessina crossover to AG200-15Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy females
- 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active women requesting birth control
- In good general health, confirmed by medical history, physical (including gynecologic) examination and 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 |
|---|---|---|
| AG200-15 (cycles 1-13)Also: transdermal patchAG200-15 containing ethinyl estradiol and levonorgestrel | Drug | AG200-15 (cycles 1-13) |
| Lessina crossover to AG200-15Also: hormonal oral contraception and transdermal patchLow dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles. | Drug | Lessina crossover to AG200-15 |
Primary outcome
Pregnancy
Time frame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Pregnancy outcomes was determine by measuring 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25586864Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
- Derived from this study: PubMed 25582984Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.
- Derived from this study: PubMed 24402597Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Rubin A, Foegh M. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
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.
Elizabeth Garner, MD, MPH study director
Agile Therapeutics
80 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 (cycles 1-13) and Lessina crossover to AG200-15 in people with Contraception, run by Agile Therapeutics at 80 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 5 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 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 3 Jul 2018). 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 (time frame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year). 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 NCT01181479, which also lists 3 linked publications.
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 3 Jul 2018.