Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.
To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG890-6.5 | Experimental | Evaluate levonorgestrel delivery in AG890-6.5 |
|
| AG890-12.5 | Experimental | Evaluate levonorgestrel delivery in AG890-12.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel | Drug | transdermal contraceptive delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levonorgestrel Pharmacokinetic Profile | The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study. | 8 weeks |
| Evaluation of Patch Adhesion | Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale: 0: ≥90% adhered (no lift)
| 8 weeks |
| Evaluation of Irritation at Patch Application Site | Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale: 0: None
| 8 weeks |
| Evaluation of Itching at Patch Application Site | Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0. None
| 8 weeks |
| Cycle Control | Measurement of unscheduled bleeding/spotting days. | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Garner, MD, PHD | Agile Therapeutics | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AG890-6.5 | Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system |
| FG001 | AG890-12.5 | Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AG890-6.5 | Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system |
| BG001 | AG890-12.5 | Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system |
| 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 | Levonorgestrel Pharmacokinetic Profile | The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study. | Primary PK population | Posted | Number | % of subjects below 175 pg/mL | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AG890-6.5 | Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Flood | Agile Therapeutics | 609-683-1880 | lflood@agiletherapeutics.com |
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Evaluation of Patch Adhesion | Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale: 0: ≥90% adhered (no lift)
| Safety population | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Primary | Evaluation of Irritation at Patch Application Site | Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale: 0: None
| Safety population | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Primary | Evaluation of Itching at Patch Application Site | Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0. None
| Safety Population | Posted | Mean | Standard Deviation | Score | 8 weeks |
|
|
|
| Primary | Cycle Control | Measurement of unscheduled bleeding/spotting days. | Completed subjects | Posted | Mean | Standard Deviation | days | 8 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 11 |
| 18 |
| EG001 | AG890-12.5 | Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system | 0 | 18 | 0 | 18 | 9 | 18 |
| Immune system disorders | Immune system disorders | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
|
| Reproductive system ad breast disorders | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
All publications must be reviewed and approved by sponsor
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004864 | Equipment and Supplies |