Healthy
Conditions
Keywords
prevention of pregnancy
Brief summary
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
Detailed description
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.
Interventions
DRUGAG200-15
Transdermal contraceptive delivery system
Sponsors
Agile Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year * Ability to demonstrate willingness to participate and adhere to study protocol
Exclusion criteria
* Known or suspected pregnancy * Lactating women * Anticipates use of condoms or any other form of back-up contraception during the study * History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc. * Has a contraindication to combined estrogen-progestin contraceptive use * Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) * Smoker who is 35 years old or over
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset | 1 year | 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. |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset | 1 year | 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. |
| Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Skin Irritation at Application Site | 1 year | Self-reported skin irritation at application site was assessed using the following scoring method: 0: None 1. Mild 2. Moderate 3. Severe |
| Self-reported Skin Itching at Application Site | 1 year | Self-reported skin itching at application site was assessed using the following scoring method: 0: None 1. Mild 2. Moderate 3. Severe |
| Self-reported Patch Adhesion | 1 year | 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. |
| Cycle Control | 1 year | Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2,031 |
| Total | 2,031 |
Baseline characteristics
| Characteristic | AG200-15 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2031 Participants |
| Age, Continuous | 27.5 years STANDARD_DEVIATION 6.21 |
| Region of Enrollment United States | 2031 Participants |
| Sex: Female, Male Female | 2031 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,031 |
| other Total, other adverse events | 627 / 2,031 |
| serious Total, serious adverse events | 40 / 2,031 |
Outcome results
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.
Time frame: 1 year
Population: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. | 5.80 Pearl Index |
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.
Time frame: 1 year
Population: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset | 5.7 Pearl Index |
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.
Time frame: 1 year
Population: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset | 3.5 Pearl Index |
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.
Time frame: 1 year
Population: ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset | 8.6 Pearl Index |
Other Pre-specified
Cycle Control
Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.
Time frame: 1 year
Population: Subjects that reported BTB and/or BTS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG200-15 | Cycle Control | 0.56 Episodes/cycle | Standard Deviation 0.391 |
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) 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.
Time frame: 1 year
Population: Subjects that reported patch adhesion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG200-15 | Self-reported Patch Adhesion | 2.76 Score | Standard Deviation 1.518 |
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 1. Mild 2. Moderate 3. Severe
Time frame: 1 year
Population: Subjects who reported irritation at the application site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG200-15 | Self-reported Skin Irritation at Application Site | 1.31 Score | Standard Deviation 1.02 |
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 1. Mild 2. Moderate 3. Severe
Time frame: 1 year
Population: Subjects who reported itching at the application site
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG200-15 | Self-reported Skin Itching at Application Site | 1.6 Score | Standard Deviation 0.951 |