Contraception
Conditions
Keywords
Contraceptive
Brief summary
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
Detailed description
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).
Interventions
DRUGAG200-15
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period.
DRUGLevora
One tablet of Levora will be taken each day for a 28 day cycle.
Sponsors
Agile Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* sexually active women requesting contraception * Regular menses every 24 - 35 days * In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values
Exclusion criteria
* Known or suspected pregnancy * Lactating women * Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape * Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) * Use of other contraceptive methods than study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Reported as Pearl Index | 6 months | 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 |
|---|---|---|
| Safety | 6 months | Adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cycle Control | 6 months | The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles. |
| Irritation and Itching at Application Site | 6 months | AG200-15 irritation and itching scores are defined as follows: 0=none 1. mild 2. moderate 3. severe |
| Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | 3 months and 6 months | Measurement of plasma levels of levonorgestrel and ethinyl estradiol. |
| Adhesion at Application Site | 6 months | Measurement of adhesion of application site is defined as follows: 0: \>=90% adhered (no lifting) 1. \>=75% adhered but \<90% (some edges showing lifting) 2. \>=50% adhered but \<75% (half of the patch lifts off) 3. \<50% (\> half of patch lifts off, but not detached) 4. patch completely detached |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AG200-15 Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period. | 177 |
| Levora hormonal oral contraceptive | 188 |
| Total | 365 |
Baseline characteristics
| Characteristic | AG200-15 | Levora | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 177 Participants | 188 Participants | 365 Participants |
| Region of Enrollment United States | 177 Participants | 188 Participants | 365 Participants |
| Sex: Female, Male Female | 177 Participants | 188 Participants | 365 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 0 / 188 |
| other Total, other adverse events | 42 / 177 | 45 / 188 |
| serious Total, serious adverse events | 0 / 177 | 2 / 188 |
Outcome results
Primary
Pregnancy Reported as Pearl Index
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: 6 months
Population: Intent-to-treat population ages 18-35.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Pregnancy Reported as Pearl Index | 8.19 Pearl Index |
| Levora | Pregnancy Reported as Pearl Index | 6.80 Pearl Index |
Secondary
Safety
Adverse events
Time frame: 6 months
Population: Any subject who applied a patch.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Safety | 85 Events |
| Levora | Safety | 88 Events |
Other Pre-specified
Adhesion at Application Site
Measurement of adhesion of application site is defined as follows: 0: \>=90% adhered (no lifting) 1. \>=75% adhered but \<90% (some edges showing lifting) 2. \>=50% adhered but \<75% (half of the patch lifts off) 3. \<50% (\> half of patch lifts off, but not detached) 4. patch completely detached
Time frame: 6 months
Population: Subjects that have documented adhesion scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG200-15 | Adhesion at Application Site | 0.46 Score | Standard Deviation 1.118 |
Other Pre-specified
Cycle Control
The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.
Time frame: 6 months
Population: Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AG200-15 | Cycle Control | 24.5 percent cycles with BTB or BTS |
| Levora | Cycle Control | 21 percent cycles with BTB or BTS |
Comparison: Comparative evaluation of AG200-15 and Levorap-value: 0.089Chi-squared
Other Pre-specified
Irritation and Itching at Application Site
AG200-15 irritation and itching scores are defined as follows: 0=none 1. mild 2. moderate 3. severe
Time frame: 6 months
Population: Subject self-reported worse irritation score in a cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AG200-15 | Irritation and Itching at Application Site | Irritation Score (cycles 1-6 combined) | 1.15 Score | Standard Deviation 0.914 |
| AG200-15 | Irritation and Itching at Application Site | Itching Score (cycles 1-6 combined) | 1.31 Score | Standard Deviation 0.851 |
Other Pre-specified
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
Measurement of plasma levels of levonorgestrel and ethinyl estradiol.
Time frame: 3 months and 6 months
Population: Number of subjects with available LNG data for cycle 3 or cycle 6
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AG200-15 | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | LNG cycle 3 | 2244 pg/mL |
| AG200-15 | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | LNG cycle 6 | 1743 pg/mL |
| AG200-15 | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | EE cycle 3 | 44.5 pg/mL |
| AG200-15 | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | EE cycle 6 | 34.7 pg/mL |
| Levora | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | EE cycle 6 | 54.7 pg/mL |
| Levora | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | LNG cycle 3 | 3474 pg/mL |
| Levora | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | EE cycle 3 | 50.6 pg/mL |
| Levora | Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) | LNG cycle 6 | 3682 pg/mL |