A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Evaluation of Patch Adhesion
研究概览
简要总结
Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.
详细描述
To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) greater than or equal to
- •Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
- •Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study.
排除标准
- •Known or suspected pregnancy
- •Lactating women
- •Status post-partum or post-abortion within a period of 2 months prior to the start of study medication
- •A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
- •Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic)
- •Valvular heart disease with complications
- •ECG (in women with BMI ≥35 kg/m2) with clinically significant findings
- •Diabetes Mellitus
- •History of headaches with focal neurological symptoms
- •Uncontrolled thyroid disorder
- •Sickle cell anemia
- •Current or history of clinically significant depression in the last year
- •Known disturbance of lipid metabolism
- •Acute or chronic hepatocellular disease with abnormal liver function
- •Hepatic adenoma or carcinoma
- •Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
- •Plans for major surgery
- •History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
- •Undiagnosed abnormal genital bleeding
- •Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia
- •History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)
- •Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit
- •Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit
- •Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit
- •Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
- •A recent history (within prior 2 years ) of drug or alcohol abuse
研究组 & 干预措施
AG890-6.5
Evaluate levonorgestrel delivery in AG890-6.5
干预措施: levonorgestrel (Drug)
AG890-12.5
Evaluate levonorgestrel delivery in AG890-12.5
干预措施: levonorgestrel (Drug)
结局指标
主要结局
Evaluation of Patch Adhesion
时间窗: 8 weeks
Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale: 0: ≥90% adhered (no lift) 1. ≥75% adhered but \<90% (some edges showing lift) 2. ≥50% adhered but \<75% (half of system lifts off) 3. \<50% (\< half of system lifts off, but undetached) 4. patch completely detached
Evaluation of Irritation at Patch Application Site
时间窗: 8 weeks
Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale: 0: None 1. Mild 2. Moderate 3. Severe
Evaluation of Itching at Patch Application Site
时间窗: 8 weeks
Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0. None 1. Mild 2. Moderate 3. Severe
Cycle Control
时间窗: 8 weeks
Measurement of unscheduled bleeding/spotting days.
Levonorgestrel Pharmacokinetic Profile
时间窗: 8 weeks
The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.
次要结局
未报告次要终点