Phase 1
Completed N=36
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Healthy
Source: ClinicalTrials.gov NCT01243580 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 — 135; 45.5 pg/ml — p=<0.0001
Summary
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1 |
135; 45.5 | <0.0001 sig |
| PRIMARY Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3 |
131; 51.3 | <0.0001 sig |
| PRIMARY Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1 |
7.28; 5.06 | 0.0001 sig |
| PRIMARY Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3 |
6.97; 6.26 | 0.0532 |
| PRIMARY Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1 |
43.3; 31.4 | 0.0009 sig |
| PRIMARY Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3 |
41.5; 35.7 | 0.0167 sig |
| PRIMARY Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1 |
43.3; 32.0 | 0.0007 sig |
| PRIMARY Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3 |
41.5; 35.7 | 0.0175 sig |
| PRIMARY Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1 |
43.3; 30.1 | 0.0001 sig |
| PRIMARY Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3 |
41.5; 37.3 | 0.0532 |
| PRIMARY Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 |
1370; 2400 | — |
| PRIMARY Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3 |
160; 317 | — |
| PRIMARY Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3 |
1060; 1847 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy women, ages 18-45
- Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
- Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
- Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period
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
- Smokers
Data sourced from ClinicalTrials.gov (NCT01243580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.