Phase 3
Completed N=407
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Source: ClinicalTrials.gov NCT01236768 ↗Enrolled (actual)
407
Serious AEs
0.5%
Results posted
Sep 2017
Primary outcomePrimary: Pregnancy Reported as Pearl Index — 8.19; 6.80 Pearl Index
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Reported as Pearl Index |
8.19; 6.80 | — |
| SECONDARY Safety |
85; 88 | — |
Eligibility Criteria
Inclusion Criteria
- sexually active women requesting contraception
- Regular menses every 24 - 35 days
- In good general health, confirmed by medical history, physical (including gynecologic examination adn 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 (NCT01236768). 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.