Trial Outcomes & Findings for Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System (NCT NCT02158572)
NCT ID: NCT02158572
Last Updated: 2020-05-06
Results Overview
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.
COMPLETED
PHASE3
2032 participants
1 year
2020-05-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
2032
|
|
Overall Study
COMPLETED
|
989
|
|
Overall Study
NOT COMPLETED
|
1043
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Baseline characteristics by cohort
| Measure |
AG200-15
n=2031 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2031 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2031 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2031 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
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.
Outcome measures
| Measure |
AG200-15
n=1736 Participants
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
|
|---|---|
|
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.
|
5.80 Pearl Index
Interval 4.5 to 7.2
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SECONDARY outcome
Timeframe: 1 yearPopulation: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
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.
Outcome measures
| Measure |
AG200-15
n=684 Participants
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
|
|---|---|
|
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset
|
3.5 Pearl Index
Interval 1.8 to 5.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
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.
Outcome measures
| Measure |
AG200-15
n=439 Participants
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
|
|---|---|
|
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset
|
5.7 Pearl Index
Interval 3.0 to 8.4
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
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.
Outcome measures
| Measure |
AG200-15
n=612 Participants
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
|
|---|---|
|
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset
|
8.6 Pearl Index
Interval 5.8 to 11.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Subjects who reported irritation at the application site.
Self-reported skin irritation at application site was assessed using the following scoring method: 0: None 1. Mild 2. Moderate 3. Severe
Outcome measures
| Measure |
AG200-15
n=2023 Participants
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
|
|---|---|
|
Self-reported Skin Irritation at Application Site
|
1.31 Score
Standard Deviation 1.020
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Subjects who reported itching at the application site
Self-reported skin itching at application site was assessed using the following scoring method: 0: None 1. Mild 2. Moderate 3. Severe
Outcome measures
| Measure |
AG200-15
n=2023 Participants
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
|
|---|---|
|
Self-reported Skin Itching at Application Site
|
1.6 Score
Standard Deviation 0.951
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Subjects that reported patch adhesion
Patch adhesion was reported using the following 5-point scoring method: 0: ≥ 90% adhered (none to minimal lift) 1. ≥ 75% adhered but \< 90% (some edges showing lift) 2. ≥ 50% adhered but \< 75% (at least half of system lifts off) 3. \< 50% (more than half of the patch lifts off, but the patch remains attached) 4. Patch completely detached.
Outcome measures
| Measure |
AG200-15
n=2022 Participants
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
|
|---|---|
|
Self-reported Patch Adhesion
|
2.76 Score
Standard Deviation 1.518
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Subjects that reported BTB and/or BTS
Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.
Outcome measures
| Measure |
AG200-15
n=2017 Participants
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
|
|---|---|
|
Cycle Control
|
0.56 Episodes/cycle
Standard Deviation 0.391
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Adverse Events
AG200-15
Serious adverse events
| Measure |
AG200-15
n=2031 participants at risk
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
|
|---|---|
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Hepatobiliary disorders
Cholelithiasis
|
0.20%
4/2031 • Number of events 4 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
3/2031 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Major depression
|
0.15%
3/2031 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
3/2031 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
4/2031 • Number of events 4 • 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.15%
3/2031 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.10%
2/2031 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute repiratory distress syndrome
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Alcohol use
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Appendicitis
|
0.10%
2/2031 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Corona virus infection
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Endometriosis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric fistula
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hemiparesis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Metapneumovirus infection
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
General disorders
Multiorgan failure
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Oliguira
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thryriod cancer
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Phenylketonuria
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Septic shock
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Suicidal Ideation
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Suicide Attempt
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Viral Infection
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Bipolar Disorder
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Heptitis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Infections and infestations
Small Intestine Gangrene
|
0.05%
1/2031 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Substance Abuse
|
0.05%
1/2031 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
AG200-15
n=2031 participants at risk
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
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
116/2031 • Number of events 116 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
4.9%
100/2031 • Number of events 100 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
4.1%
84/2031 • Number of events 84 • 1 year
|
|
Nervous system disorders
Headache
|
3.5%
72/2031 • Number of events 72 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
3.5%
72/2031 • Number of events 72 • 1 year
|
|
Infections and infestations
Sinusitis
|
2.7%
54/2031 • Number of events 54 • 1 year
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.3%
47/2031 • Number of events 47 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
41/2031 • Number of events 41 • 1 year
|
|
Investigations
Weight increased
|
2.0%
41/2031 • Number of events 41 • 1 year
|
Additional Information
Michelle Previtera, Associate Director of Clinical Development
Agile Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER