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

Conditions

• Residual Drug Amount of EE and LNG

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Twirla® (Levonorgestrel/Ethinyl Estradiol) Transdermal System — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jul 31, 2026

Start date

Oct 25, 2021

Status verified

Jul 2026

Primary completion

Nov 16, 2021

Completion

Nov 16, 2021

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: 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.

Primary Outcome Measure

The sum of means for EE and LNG content on used TDSs, storage pouches, release liners, and skin swabs [ Time Frame: 7 days ]

Locations (1)

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