Phase 3
Completed N=2,032
Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Healthy
Source: ClinicalTrials.gov NCT02158572 ↗
Enrolled (actual)
2,032
Serious AEs
2.0%
Results posted
Sep 2017
Primary outcomePrimary: Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. — 5.80 Pearl Index
◆ Published Evidence
Established
32citations · ~6 / year
Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.
Summary
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
Linked Publications
-
Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset. |
5.80 | — |
| SECONDARY Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset |
3.5 | — |
| SECONDARY Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset |
5.7 | — |
| SECONDARY Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset |
8.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02158572) and the linked publication. 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.