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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG200-15 | Experimental | Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) |
|
| Levora | Active Comparator | oral contraceptive containing 150mcg of LNG and 30mcg of EE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG200-15 | Drug | Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle Control | The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles. | 6 months |
| Irritation and Itching at Application Site |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Foegh, MD | Agile Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | AG200-15 | Transdermal contraceptive delivery system (TCDS) |
| FG001 | Levora | hormonal oral contraceptive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Levora | Drug | One tablet of Levora will be taken each day for a 28 day cycle. |
|
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AG200-15 irritation and itching scores are defined as follows:
0=none
| 6 months |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Measurement of plasma levels of levonorgestrel and ethinyl estradiol. | 3 months and 6 months |
| Adhesion at Application Site | Measurement of adhesion of application site is defined as follows: 0: >=90% adhered (no lifting)
| 6 months |
| Green Valley |
| Arizona |
| 85614 |
| United States |
| Tucson | Arizona | 85712 | United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90057 | United States |
| West Hills | California | 91307 | United States |
| Boynton Beach | Florida | 33472 | United States |
| South Miami | Florida | 33143 | United States |
| St. Petersburg | Florida | 33709 | United States |
| Newburgh | Indiana | 47630 | United States |
| Louisville | Kentucky | 40291 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Las Vegas | Nevada | 89128 | United States |
| Kernersville | North Carolina | 27284 | United States |
| Englewood | Ohio | 45322 | United States |
| Tulsa | Oklahoma | 74105 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Sugar Land | Texas | 77479 | United States |
| Newport News | Virginia | 23606 | United States |
| Norfolk | Virginia | 23502 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population (number of subjects that received drug)
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| ID | Title | Description |
|---|---|---|
| BG000 | AG200-15 | Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. |
| BG001 | Levora | hormonal oral contraceptive |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat population ages 18-35. | Posted | Number | 95% Confidence Interval | Pearl Index | 6 months |
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| Secondary | Safety | Adverse events | Any subject who applied a patch. | Posted | Number | Events | 6 months |
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| Other Pre-specified | Cycle Control | The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles. | Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle. | Posted | Number | percent cycles with BTB or BTS | 6 months |
|
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| Other Pre-specified | Irritation and Itching at Application Site | AG200-15 irritation and itching scores are defined as follows: 0=none
| Subject self-reported worse irritation score in a cycle. | Posted | Mean | Standard Deviation | Score | 6 months |
|
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| Other Pre-specified | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | Measurement of plasma levels of levonorgestrel and ethinyl estradiol. | Number of subjects with available LNG data for cycle 3 or cycle 6 | Posted | Mean | 95% Confidence Interval | pg/mL | 3 months and 6 months |
|
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| Other Pre-specified | Adhesion at Application Site | Measurement of adhesion of application site is defined as follows: 0: >=90% adhered (no lifting)
| Subjects that have documented adhesion scores. | Posted | Mean | Standard Deviation | Score | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AG200-15 | Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. | 0 | 177 | 0 | 177 | 42 | 177 |
| EG001 | Levora | oral contraceptive containing 150mcg of LNG and 30mcg of EE Levora: One tablet of Levora will be taken each day for a 28 day cycle. | 0 | 188 | 2 | 188 | 45 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Murine Typhus | Infections and infestations | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cervical dysplasia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Review and approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL13 study is required prior to publication submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Flood, Associate Director of Clinical Operations | Agile Therapeutics | 609-683-1880 | lflood@agiletherapeutics.com |
| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| D003278 | Contraceptives, Oral, Hormonal |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000080066 | Contraceptive Agents, Hormonal |
| D045506 | Therapeutic Uses |
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| >=65 years |
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| Male |
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