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Do birth control patches deliver their full dose? a study checks the leftovers

NCT ID NCT07739589

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study looks at how much of the hormones levonorgestrel and ethinyl estradiol remain in used TWIRLA birth control patches after a week of wear. Healthy women aged 18 to 40 will wear a single patch for 7 days, and researchers will measure the leftover hormone amounts on the patch, its packaging, and the skin. The goal is to confirm that the patch delivers a consistent dose of hormones as intended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system
What this could lead to
If successful, this could confirm that the patch delivers a consistent dose of hormones, supporting its safe and effective use as a birth control method.
What could go wrong
This is a small, post-marketing study focused on measuring leftover hormone amounts, not on how well the patch prevents pregnancy. Results may not reflect real-world usage or individual variation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

28 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, including hormonal contraception (e.g., worsening of a disease or condition while on hormonal contraception) * History of dermal hypersensitivity in response to medicated TDSs (e.g., nicotine TDS) or topical applications (bandages, surgical tape, etc.); known hypersensitivity to any components of the Twirla®, or prior difficulties with transdermal methods for any indication * Presence on the lower abdomen of skin changes that, at the discretion of the Investigator, would have potentially interfered with TDS adhesion or TDS application site assessment, including for example tattoos, striae, scarring or other skin damage, skin lesions, skin irritation, diffuse skin disease (e.g., psoriasis, eczema, rash, or any etiology), excessive stretch marks, or excess hair at the TDS application site * Preclusion of TDS placement, at the discretion of the Investigator, on the lower abdomen * Has a contraindication to combined estrogen-progestin contraceptive use (as defined by a category 3 or 4 condition of the 2016 U.S. Medical Eligibility Criteria for Contraceptive Use), including: * Personal history of or DVT or venous thromboembolism * History of stroke, vascular or cerebral vascular disease including TIAs or coronary artery disease * Known inherited or acquired hypercoagulopathy, including thrombogenic mutations (e.g., factor V Leiden; prothrombin mutation; protein S, protein C, or antithrombin deficiency) * Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies * Known or suspected carcinoma of the breast, including past personal history of breast cancer * Jaundice with prior CHC use * Hepatocellular adenoma or carcinoma * Severe cirrhosis * Symptomatic current gallbladder disease * Current smokers 35 years of age or over, or smoker who would have turned 35 years old during the course of the trial (Smoking includes cigarettes, cigars, smokeless tobacco, e-cigarettes, hookah, etc.) * Headaches with focal neurological symptoms (i.e., migraines with auras) * Migraines of any type in women over 35 years of age * Diabetes mellitus with nephropathy, neuropathy, retinopathy, or other vascular disease; diabetes mellitus of ˃20 year's duration * Elevated blood pressure, defined as screening sitting blood pressure ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic; or hypertension with known vascular disease * History of peripartum cardiomyopathy * Known thrombophilia, including antiphospholipid antibody syndrome * History of any other condition that in the Investigator's opinion suggests an elevated risk of arterial or venous thromboembolic disease * Carcinoma of the endometrium, ovary, fallopian tubes, or other known or suspected estrogen-dependent malignant or pre-malignant neoplasia * Other active malignancy, excluding non-melanoma skin cancer * Known history of acute or chronic hepatocellular disease with a history of significantly abnormal liver function, or liver function tests (LFTs) ≥ 2x normal * Known history of Triglycerides ≥ 350 mg/dL * Thrombogenic valvular or thrombogenic rhythm diseases of the heart (e.g., subacute bacterial endocarditis with valvular disease or atrial fibrillation). * Uncontrolled diabetes mellitus; participants with a history of gestational diabetes are eligible for the study if they are currently euglycemic * Uncontrolled thyroid disorder * Known HIV and/or hepatitis B or C infection * History of suicidal ideation or attempt, or history of severe depression requiring hospitalization within the past year * Recent history (within prior 12 months) of drug or alcohol abuse or at Investigator discretion, history greater than 12 months prior and at risk for noncompliance * Positive urine drug screen for Cocaine, Methamphetamine, Opiates, Phencyclidine unless there is a documented prescription with supporting medical history and diagnosis * Administration of any investigational drug and/or experimental device within 30 days prior to enrollment; planned administration of an experimental drug or device during the duration of the study; current participation in any investigational studies * In the Investigator's judgement, woman was unsuitable for participation in the study or who could not comply with study procedures * Participant was a dependent of (e.g., relative or family member) and/or was a member of the Investigator's staff.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • TKL Research Inc.

    Fair Lawn, New Jersey, 07410, United States