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Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG200-15 | Experimental | AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG200-15 | Drug | Transdermal contraceptive delivery system |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. | The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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 year |
| Measure | Description | Time Frame |
|---|---|---|
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 25 kg/m2, ITT dataset. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Skin Irritation at Application Site | Self-reported skin irritation at application site was assessed using the following scoring method: 0: None
| 1 year |
| Self-reported Skin Itching at Application Site |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Garner, MD, MPH | Agile Therapeutics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33259782 | Derived | Nelson AL, Kaunitz AM, Kroll R, Simon JA, Poindexter AN, Castano PM, Ackerman RT, Flood L, Chiodo JA 3rd, Garner EI; SECURE Investigators. Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results. Contraception. 2021 Mar;103(3):137-143. doi: 10.1016/j.contraception.2020.11.011. Epub 2020 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AG200-15 | AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) AG200-15: Transdermal contraceptive delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AG200-15 | AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) AG200-15: 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 | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. | The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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. | ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used. | Posted | Number | 95% Confidence Interval | Pearl Index | 1 year |
|
1 year
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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 | AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) AG200-15: Transdermal contraceptive delivery system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Previtera, Associate Director of Clinical Development | Agile Therapeutics | 609-683-1880 | mprevitera@agiletherapeutics.com |
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| 1 year |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 25 and < 30 kg/m2, ITT dataset. 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 year |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 30 kg/m2, ITT dataset. 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 year |
Self-reported skin itching at application site was assessed using the following scoring method:
0: None
| 1 year |
| Self-reported Patch Adhesion | Patch adhesion was reported using the following 5-point scoring method: 0: ≥ 90% adhered (none to minimal lift)
| 1 year |
| Cycle Control | Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle. | 1 year |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 25 kg/m2, ITT dataset. 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. | ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used. | Posted | Number | 95% Confidence Interval | Pearl Index | 1 year |
|
|
|
| Secondary | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 25 and < 30 kg/m2, ITT dataset. 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. | ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used. | Posted | Number | 95% Confidence Interval | Pearl Index | 1 year |
|
|
|
| Other Pre-specified | Self-reported Skin Irritation at Application Site | Self-reported skin irritation at application site was assessed using the following scoring method: 0: None
| Subjects who reported irritation at the application site. | Posted | Mean | Standard Deviation | Score | 1 year |
|
|
|
| Other Pre-specified | Self-reported Skin Itching at Application Site | Self-reported skin itching at application site was assessed using the following scoring method: 0: None
| Subjects who reported itching at the application site | Posted | Mean | Standard Deviation | Score | 1 year |
|
|
|
| Other Pre-specified | Self-reported Patch Adhesion | Patch adhesion was reported using the following 5-point scoring method: 0: ≥ 90% adhered (none to minimal lift)
| Subjects that reported patch adhesion | Posted | Mean | Standard Deviation | Score | 1 year |
|
|
|
| Other Pre-specified | Cycle Control | Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle. | Subjects that reported BTB and/or BTS | Posted | Mean | Standard Deviation | Episodes/cycle | 1 year |
|
|
|
| Secondary | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset | Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 30 kg/m2, ITT dataset. 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. | ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used. | Posted | Number | 95% Confidence Interval | Pearl Index | 1 year |
|
|
|
| 0 |
| 2,031 |
| 40 |
| 2,031 |
| 627 |
| 2,031 |
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute repiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Alcohol use | Psychiatric disorders | Non-systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Corona virus infection | Infections and infestations | Non-systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gastric fistula | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | Non-systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | Non-systematic Assessment |
|
| Metapneumovirus infection | Infections and infestations | Non-systematic Assessment |
|
| Multiorgan failure | General disorders | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | Non-systematic Assessment |
|
| Oliguira | Renal and urinary disorders | Non-systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | Non-systematic Assessment |
|
| Papillary thryriod cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Phenylketonuria | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | Non-systematic Assessment |
|
| Bipolar Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Heptitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
|
| Small Intestine Gangrene | Infections and infestations | Non-systematic Assessment |
|
| Substance Abuse | Psychiatric disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL23 study is required prior to publication submission.