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Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).
Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-Cyclen® | Active Comparator | Ortho-Cyclen® is a comparator drug intervention |
|
| AG200-15 | Experimental | AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho-Cyclen | Drug | Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3. | 3 months |
| Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | 3 months |
| Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. | 3 months |
| Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | 3 months |
| Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. | 3 months |
| Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Garner, MD, MPH | Agile Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33169 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22133660 | Derived | Archer DF, Stanczyk FZ, Rubin A, Foegh M. Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. Contraception. 2012 Jun;85(6):595-601. doi: 10.1016/j.contraception.2011.10.006. Epub 2011 Nov 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AG200-15/Ortho-Cyclen® | AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol/ 100-120 mcg levonorgestrel per day, was applied weekly for 3 consecutive weeks and was removed on the 4th week for a patch free week. This regimen occurred for Cycles 1 and 2. For cycle 3, Ortho-Cyclen® containing 250 mcg norgestimate and 35 mcg ethinyl estradiol was taken daily for 21 days followed by a drug free interval of 7 days. |
| FG001 | Ortho-Cyclen®/AG200-15 | AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol and 100-120 mcg levonorgestrel per day, was applied for 3 consecutive weeks and removed on the 4th week for a patch free week. This regimen occurred for Cycle 1 and Cycle 3. Ortho-Cyclen®, containing 250 mcg norgestimate and 35 mcg ethinyl estradiol, was taken daily for 21 days followed by a drug free interval of 7 days for Cycle 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AG200-15/Ortho-Cyclen® | Subject applied AG200-15 in cycle 1. Subjects applied AG200-15 (Cycle 2) followed by oral contraceptive, Ortho-Cyclen® (Cycle 3) |
| BG001 | Ortho-Cyclen® /AG200-15 |
| 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 |
| 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 | Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
3 months
Adverse events were analyzed based on Organ System class.
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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 | Ortho-Cyclen® | Ortho-Cyclen® is a comparator drug intervention Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Flood | Agile Therapeutics | 609-683-1880 | lflood@agiletherapeutics.com |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| AG200-15 | Drug | AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE |
|
|
| 3 months |
| Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months |
| Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months |
| Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | 3 months |
| Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | 3 months |
| Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 | Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | 3 months |
| Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3 | Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | 3 months |
| Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | 3 months |
Subject applied AG200-15 in cycle 1. Subjects received Ortho-Cyclen® (Cycle 2) followed by AG200-15 (Cycle 3).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | ng.h/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | ng.h/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured. | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3 | Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval). | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
|
| Primary | Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 | Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
| Primary | Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3 | Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3. | Primary PK population | Posted | Mean | Standard Deviation | ng.h/ml | 3 months |
|
|
|
| Primary | Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3 | Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval). | Primary PK population | Posted | Mean | Standard Deviation | pg/ml | 3 months |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 3 |
| 34 |
| EG001 | AG200-15 | AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE | 0 | 36 | 0 | 36 | 23 | 36 |
| General disorders and application site conditions | General disorders | Non-systematic Assessment |
|
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscoloskeletal and conncetive tissue disoders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nervous system disoders | Nervous system disorders | Non-systematic Assessment |
|
| Reproductive system and breast disoders | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL14 study is required prior to publication submission.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |