Phase 3
Completed N=1,504
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Source: ClinicalTrials.gov NCT01181479 ↗Enrolled (actual)
1,504
Serious AEs
1.1%
Results posted
Jul 2018
Primary outcomePrimary: Pregnancy — 5.41; 6.67; 6.43 Pearl Index
◆ Published Evidence
Established
25citations · ~2 / year
Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial.
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.
Linked Publications (3)
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Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial.
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Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill.
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New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy |
5.41; 6.67; 6.43 | — |
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) 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.