A Phase 3 interventional study of AG200-15 (cycles 1-13) and Lessina crossover to AG200-15 in Contraception, sponsored by Agile Therapeutics. Completed at 80 sites in United States. Open to female participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.
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, 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.
Healthy females
Exclusion Criteria:
AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.
Drug: AG200-15 (cycles 1-13)
Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
Drug: Lessina crossover to AG200-15
AG200-15 containing ethinyl estradiol and levonorgestrel
Also known as: transdermal patch
Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Also known as: hormonal oral contraception and transdermal patch
Pregnancy
Pregnancy outcomes was determine by measuring 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: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year
Cycle Control
Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.
Time frame: 6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.
Time frame: Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
Self-reported Irritation at Application Site
Evaluation of irritation at application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe
Time frame: 1 year
Patch Adhesion by Investigator Evaluation at Each Visit
Evaluation of patch adhesion was determined using the following scores: 0: \>= 90% adhered (no lift) 1. \>= 75% adhered but \< 90% (some edges showing lift) 2. \>= 50% adhered but \< 75% (half of system lifts off) 3. \< 50% (\> half of system lifts off, but undetached) 4. patch completely detached
Time frame: 1 year
Self-reported Itching at Patch Application Site
Evaluation of itching at patch application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe
Time frame: 1 year
| Milestone | AG200-15 (Cycles 1-13) | Lessina (Cycles 1-6) | Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13) |
|---|---|---|---|
| Started | 1129 | 375 | 0 |
| Completed | 485 | 249 | 0 |
| Not completed | 644 | 126 | 0 |
| Milestone | AG200-15 (Cycles 1-13) | Lessina (Cycles 1-6) | Lessina (Cycles 1-6) Crossover to AG200-15 (Cycles 7-13) |
|---|---|---|---|
| Started | 0 | 0 | 249 |
| Completed | 0 | 0 | 150 |
| Not completed | 0 | 0 | 99 |
Pregnancy outcomes was determine by measuring 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.
| Pearl Index | AG200-15 for Cycle 7-13 | Lessina | AG200-15 for Cycle 1-13 |
|---|---|---|---|
| Pregnancy | 5.41 (2.35 to 8.46) | 6.67 (0.84 to 12.5) | 6.43 (4.13 to 8.72) |
Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.
| percentage of cycles with BTB/BTS | AG200-15 for Cycle 1-6 | Lessina |
|---|---|---|
| Cycle Control | 23.9 | 21.2 |
Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.
| pg/ml | Lessina Cycles 1-6 | AG200-15 for Cycle 1-13 | AG200-15 for Cycles 7-13 |
|---|---|---|---|
| EE for cycle 2 | 35.4 (31.9 to 38.8) | 30.5 (29.0 to 32.1) | NA (NA to NA) |
| EE cycle 6 | 40.1 (33.3 to 46.9) | 36.7 (34.3 to 39.0) | NA (NA to NA) |
| EE cycle 13 | NA (NA to NA) | 31 (28.5 to 33.5) | 33.4 (29.1 to 37.8) |
| LNG cycle 2 | 2386 (2180 to 2592) | 1201 (1136 to 1266) | NA (NA to NA) |
| LNG cycle 6 | 2611 (2355 to 2867) | 1753 (1636 to 1871) | NA (NA to NA) |
| LNG cycle 13 | NA (NA to NA) | 1590 (1452 to 1727) | 1750 (1521 to 1979) |
Evaluation of irritation at application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe
| Score on scale | All Subjects Who Applied AG200-15 |
|---|---|
| Self-reported Irritation at Application Site | 1.35 ± 0.964 |
Evaluation of patch adhesion was determined using the following scores: 0: \>= 90% adhered (no lift) 1. \>= 75% adhered but \< 90% (some edges showing lift) 2. \>= 50% adhered but \< 75% (half of system lifts off) 3. \< 50% (\> half of system lifts off, but undetached) 4. patch completely detached
| Score on a scale | All Subjects Who Applied AG200-15 |
|---|---|
| Patch Adhesion by Investigator Evaluation at Each Visit | 0.29 ± 0.823 |
Evaluation of itching at patch application site was determined using the following scores: 0: None 1. Mild 2. Moderate 3. Severe
| Score on a scale | All Subjects Who Applied AG200-15 |
|---|---|
| Self-reported Itching at Patch Application Site | 1.48 ± 0.948 |
Non-serious events are listed at a 2.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All AG200-15 | 0/1,273 (0%) | 14/1,273 (1.1%) | 484/1,273 (38%) |
| Lessina | 1/344 (0.3%) | 4/344 (1.2%) | 112/344 (32.6%) |
| Event | All AG200-15 | Lessina |
|---|---|---|
| Head injuryInjury, poisoning and procedural complications | 0/1273 | 1/344 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 0/1273 | 1/344 |
| Ovarian cystReproductive system and breast disorders | 2/1273 | 1/344 |
| Liver disorderHepatobiliary disorders | 0/1273 | 1/344 |
| AppendicitisInjury, poisoning and procedural complications | 2/1273 | 0/344 |
| Suicidal IdeationPsychiatric disorders | 1/1273 | 0/344 |
| PneumoniaInfections and infestations | 1/1273 | 0/344 |
| Embolism VenousVascular disorders | 1/1273 | 0/344 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/1273 | 0/344 |
| VomitingGastrointestinal disorders | 1/1273 | 0/344 |
| Event | All AG200-15 | Lessina |
|---|---|---|
| Cervical DysplasiaReproductive system and breast disorders | 80/1273 | 17/344 |
| NasopharyngitisInfections and infestations | 74/1273 | 12/344 |
| HeadacheNervous system disorders | 50/1273 | 16/344 |
| NauseaGastrointestinal disorders | 58/1273 | 14/344 |
| Upper respiratory tract infectionInfections and infestations | 51/1273 | 7/344 |
| SinusitisInfections and infestations | 45/1273 | 9/344 |
| Urinary tract infectionInfections and infestations | 44/1273 | 11/344 |
| Human papilloma virus test positiveInvestigations | 40/1273 | 7/344 |
| VomitingGastrointestinal disorders | 22/1273 | 10/344 |
| DysmenorrheaReproductive system and breast disorders | 20/1273 | 9/344 |
Safety Population
| Age, Categorical(Participants) | AG200-15 | Lessina Crossover to AG200-15 | Total |
|---|---|---|---|
| <=18 years | 5 | 2 | 7 |
| Between 18 and 65 years | 1038 | 228 | 1266 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | AG200-15 | Lessina Crossover to AG200-15 | Total |
|---|---|---|---|
| Mean | 26.38 ± 5.663 | 26.86 ± 5.738 | 26.46 ± 5.677 |
| Sex: Female, Male(Participants) | AG200-15 | Lessina Crossover to AG200-15 | Total |
|---|---|---|---|
| Female | 1043 | 230 | 1273 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | AG200-15 | Lessina Crossover to AG200-15 | Total |
|---|---|---|---|
| United States | 1043 | 230 | 1273 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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