A Phase 3 interventional study of AG200-15 and Levora in Contraception, sponsored by Agile Therapeutics. Completed at 21 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by Agile Therapeutics · Phase 3, Interventional, and Prevention
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.
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).
Agile Therapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
Drug: AG200-15
oral contraceptive containing 150mcg of LNG and 30mcg of EE
Drug: Levora
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Also known as: Transdermal contraceptive delivery system (TCDS)
One tablet of Levora will be taken each day for a 28 day cycle.
Also known as: Hormonal oral contraceptive
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
Safety
Adverse events
Time frame: 6 months
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
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
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
Measurement of plasma levels of levonorgestrel and ethinyl estradiol.
Time frame: 3 months and 6 months
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
| Milestone | AG200-15 | Levora |
|---|---|---|
| Started | 201 | 206 |
| Completed | 112 | 145 |
| Not completed | 89 | 61 |
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.
| Pearl Index | AG200-15 | Levora |
|---|---|---|
| Pregnancy Reported as Pearl Index | 8.19 (0.19 to 16.19) | 6.80 (0.15 to 13.44) |
Adverse events
| Events | AG200-15 | Levora |
|---|---|---|
| Safety | 85 | 88 |
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.
| percent cycles with BTB or BTS | AG200-15 | Levora |
|---|---|---|
| Cycle Control | 24.5 | 21 |
AG200-15 irritation and itching scores are defined as follows: 0=none 1. mild 2. moderate 3. severe
| Score | AG200-15 |
|---|---|
| Irritation Score (cycles 1-6 combined) | 1.15 ± 0.914 |
| Itching Score (cycles 1-6 combined) | 1.31 ± 0.851 |
Measurement of plasma levels of levonorgestrel and ethinyl estradiol.
| pg/mL | AG200-15 | Levora |
|---|---|---|
| LNG cycle 3 | 2244 (1887 to 2600) | 3474 (3044 to 3904) |
| LNG cycle 6 | 1743 (1478 to 2007) | 3682 (3136 to 4228) |
| EE cycle 3 | 44.5 (38.7 to 50.3) | 50.6 (43.0 to 58.3) |
| EE cycle 6 | 34.7 (30.1 to 39.4) | 54.7 (44.8 to 64.5) |
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
| Score | AG200-15 |
|---|---|
| Adhesion at Application Site | 0.46 ± 1.118 |
Collected over 6 months. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AG200-15 | 0/177 (0%) | 0/177 (0%) | 42/177 (23.7%) |
| Levora | 0/188 (0%) | 2/188 (1.1%) | 45/188 (23.9%) |
| Event | AG200-15 | Levora |
|---|---|---|
| Murine TyphusInfections and infestations | 0/177 | 1/188 |
| ConvulsionNervous system disorders | 0/177 | 1/188 |
| Event | AG200-15 | Levora |
|---|---|---|
| NauseaGastrointestinal disorders | 5/177 | 11/188 |
| Cervical dysplasiaReproductive system and breast disorders | 10/177 | 11/188 |
| NasopharyngitisInfections and infestations | 9/177 | 8/188 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 4/177 | 8/188 |
| SinusitisInfections and infestations | 7/177 | 5/188 |
| Sinus CongestionRespiratory, thoracic and mediastinal disorders | 7/177 | 2/188 |
Safety Population (number of subjects that received drug)
| Age, Categorical(Participants) | AG200-15 | Levora | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 177 | 188 | 365 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | AG200-15 | Levora | Total |
|---|---|---|---|
| Female | 177 | 188 | 365 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(Participants) | AG200-15 | Levora | Total |
|---|---|---|---|
| United States | 177 | 188 | 365 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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