Trial Outcomes & Findings for A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal System (NCT NCT07739589)
NCT ID: NCT07739589
Last Updated: 2026-08-27
Results Overview
Measurements of Residual Ethinyl Estradiol and Levonorgestrel (μg) Per Protocol Population Post 7-Day Wear
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
7 days
Results posted on
2026-08-27
Participant Flow
Participant milestones
| Measure |
Twirla® Transdermal System
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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Overall Study
STARTED
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28
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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2
|
Reasons for withdrawal
| Measure |
Twirla® Transdermal System
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Protocol Deviation
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1
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Baseline Characteristics
A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal System
Baseline characteristics by cohort
| Measure |
Twirla® Transdermal System
n=26 Participants
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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Age, Continuous
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29.5 Age (years)
n=31 Participants
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Sex: Female, Male
Female
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26 Participants
n=31 Participants
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Sex: Female, Male
Male
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0 Participants
n=31 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=31 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
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Race (NIH/OMB)
Black or African American
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18 Participants
n=31 Participants
|
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Race (NIH/OMB)
White
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5 Participants
n=31 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=31 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=31 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=31 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=31 Participants
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Weight (kg), Mean
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66.9 kg
STANDARD_DEVIATION 7.68 • n=31 Participants
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Weight (kg), Median
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67.1 kg
n=31 Participants
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Height (cm), Mean
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161.8 cm
STANDARD_DEVIATION 6.53 • n=31 Participants
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Height (cm), Median
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159.5 cm
n=31 Participants
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BMI (kg/m2), Mean
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25.6 kg/m2
STANDARD_DEVIATION 3.33 • n=31 Participants
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BMI (kg/m2), Median
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26.2 kg/m2
n=31 Participants
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PRIMARY outcome
Timeframe: 7 daysPopulation: Per Protocol Population
Measurements of Residual Ethinyl Estradiol and Levonorgestrel (μg) Per Protocol Population Post 7-Day Wear
Outcome measures
| Measure |
Twirla® Transdermal System
n=26 Participants
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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The Sum of Means for EE and LNG Content on Used TDSs, Storage Pouches, Release Liners, and Skin Swabs
Ethinyl Estradiol (μg)
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2028.7 (μg)
Standard Deviation 43.01
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The Sum of Means for EE and LNG Content on Used TDSs, Storage Pouches, Release Liners, and Skin Swabs
Levonorgestrel (μg)
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2189.6 (μg)
Standard Deviation 62.35
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PRIMARY outcome
Timeframe: 7 daysPopulation: Five (5) controls were used to assess drug loaded for EE and LNG.
Measurements of Ethinyl Estradiol and Levonorgestrel (μg) in Controls
Outcome measures
| Measure |
Twirla® Transdermal System
n=5 control patches
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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The Sum and Means for EE and LNG Content on Control TDSs, Storage Pouches, and Release Liners
Ethinyl Estradiol (μg)
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2102.0 (μg)
Standard Deviation 85.26
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The Sum and Means for EE and LNG Content on Control TDSs, Storage Pouches, and Release Liners
Levonorgestrel (μg)
|
2454.0 (μg)
Standard Deviation 93.70
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Adverse Events
Twirla® Transdermal System
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Twirla® Transdermal System
n=28 participants at risk
Participants applied a single Twirla® transdermal system and wore it continuously for 7 days. After patch removal, residual levonorgestrel and ethinyl estradiol content was measured in the used transdermal system, packaging components, and application-site stratum corneum.
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|---|---|
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General disorders
Mild treatment emergent adverse events (TEAEs)
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28.6%
8/28 • Adverse events were monitored from the time of written informed consent to 7 days following TDS removal
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Nervous system disorders
Moderate treatment emergent adverse events (TEAEs)
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3.6%
1/28 • Adverse events were monitored from the time of written informed consent to 7 days following TDS removal
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Additional Information
Michelle L. Previtera, PhD, Associate Director, Clinical Development
Agile Therapeutics, Inc.
Phone: 877-324-9349
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place