CompletedPhase 4

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

United States28 participantsStarted 2021-10-25

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to give signed informed consent * No evidence of Coronavirus Disease 2019 (COVID-19) infection based on Centers for Disease Control and Prevention (CDC) testing and/or screening procedures * Healthy woman, 18 to 40 years of age * Body mass index (BMI) ≥ 18 kg/m² and \< 30 kg/m² * Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of the follow-up period * In good general health, confirmed by medical history, physical examination, and laboratory testing * Willing to not use other hormonal contraception including oral contraceptive, TDS, or vaginal ring, for the treatment and follow-up period Exclusion Criteria: * Known or suspected pregnancy * Breast-feeding or within 1 month after stopping breast-feeding * User of injectable contraceptives (e.g., depot-medroxyprogesterone acetate) and less than 3 months since last injection * User of progestin intrauterine device (IUD) and less than 3 months since last IUD insertion * Recent pregnancy (within 2 months), including vaginal or cesarean delivery, surgical or medically induced abortion, spontaneous abortion, or ectopic pregnancy * Unexplained vaginal bleeding * Undiagnosed abnormal genital bleeding * Diagnosis of sickle cell * Known hypersensitivity to, or intolerance of, progestins or estrogens (leading to discontinuation), including hormonal contraception; or history of serious or severe adverse event (SAE) related to progestins or estrogens,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The sum of means for EE and LNG content on used TDSs, storage pouches, release liners, and skin swabs

Timeframe: 7 days

The sum and means for EE and LNG content on control TDSs, storage pouches, and release liners

Timeframe: 7 days

Trial details

NCT IDNCT07739589

SponsorInsud Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-16

View on ClinicalTrials.gov More Residual Drug Amount of EE and LNG trials