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A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal System

NCT07739589 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-07-31

No results posted yet for this study

Summary

The objective of this open-label study was to assess residual EE and LNG content on used Twirla® TDSs, packaging, and the skin surface at the application site after 7 full days of wear and the estimate EE and LNG loaded on control TDSs using valid analytical methods.

Conditions

  • Residual Drug Amount of EE and LNG

Interventions

DRUG

Twirla® (Levonorgestrel/Ethinyl Estradiol) Transdermal System

Twirla® is a transdermal delivery system that delivers levonorgestrel and ethinyl estradiol. In this study, participants applied a single transdermal system and wore it continuously for 7 days.

Sponsors & Collaborators

  • Agile Therapeutics

    collaborator INDUSTRY

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Insud Pharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2021-11-16
Completion
2021-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07739589 on ClinicalTrials.gov