NCT07739589已完成4 期
A Postmarketing Open-Label Study to Assess Residual Levonorgestrel (LNG) and Ethinyl Estradiol (EE) Content of TWIRLA® (Levonorgestrel and Ethinyl Estradiol) Transdermal System
Insud Pharma1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The sum of means for EE and LNG content on used TDSs, storage pouches, release liners, and skin swabs
研究概览
简要总结
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.
详细描述
Twirla® (levonorgestrel and ethinyl estradiol) transdermal system is an FDA-approved transdermal delivery system (TDS) indicated as a method of contraception for use in women of reproductive potential with a body mass index (BMI) < 30 kg/m² for whom a combined hormonal contraceptive is appropriate. The 28-day TDS regimen is worn for 7 days for 3 consecutive weeks, followed by a 7-day TDS-free period.
Study ATI-CL28 measured residual EE and LNG content on Twirla® packaging (including storage pouches and release liners), Twirla® TDSs worn for 7 full days, and application site stratum corneum (SC) per Postmarketing Commitment 3785-2. Validated analytical methods were used in this study to measure residual EE and LNG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The sum of means for EE and LNG content on used TDSs, storage pouches, release liners, and skin swabs
时间窗: 7 days
The sum and means for EE and LNG content on control TDSs, storage pouches, and release liners
时间窗: 7 days
The Sum of Means for EE and LNG Content on Used TDSs, Storage Pouches, Release Liners, and Skin Swabs
时间窗: 7 days
Measurements of Residual Ethinyl Estradiol and Levonorgestrel (μg) Per Protocol Population Post 7-Day Wear
The Sum and Means for EE and LNG Content on Control TDSs, Storage Pouches, and Release Liners
时间窗: 7 days
Measurements of Ethinyl Estradiol and Levonorgestrel (μg) in Controls
次要结局
未报告次要终点
研究者
研究点 (1)
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