Phase 3
N=1,504
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01181479 ↗Enrolled (actual)
1,504
Serious AEs
1.1%
Results posted
Jul 2018
Primary outcome: Primary: Pregnancy — 5.41; 6.67; 6.43 Pearl Index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AG200-15 (cycles 1-13) (Drug); Lessina crossover to AG200-15 (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- Female
- Sponsor
- Agile Therapeutics
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy |
5.41; 6.67; 6.43 | — |
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.
Eligibility Criteria
Inclusion Criteria
Healthy females
- 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
- Regular, consistent menstrual cycles between 25 and 35 days
- Sexually active women requesting birth control
- In good general health, confirmed by medical history, physical (including gynecologic) examination and 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
Data sourced from ClinicalTrials.gov (NCT01181479). 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.