NCT05994599已完成1 期
SINGLE DOSE CROSSOVER COMPARATIVE BIOAVAILABILITY STUDY OF ETHINYL ESTRADIOL/ETONOGESTREL VAGINAL RING (DELIVERING 0.015 mg/0.12 mg PER DAY) WORN FOR 21 DAYS IN HEALTHY FEMALE SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Evestra Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring
研究概览
简要总结
Single Dose Crossover Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring (Delivering 0.015 mg/0.12 mg Per Day) Worn for 21 Days in Healthy Female Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory Blinded
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
- •Provision of signed and dated Informed Consent Form (ICF)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Healthy adult female
- •Meets 1 of the following criteria:
- •Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
- •Abstinence from heterosexual intercourse from the Screening visit through to at least 28 days after the last vaginal ring removal
- •The following double-barrier contraceptive methods, used from the Screening visit through to at least 28 days after the last vaginal ring removal:
- •Male condom with spermicide Or
- •Is of non-childbearing potential, defined as surgically sterile (ie, tubal ligation)
- •Aged at least 18 years but not older than 45 years in pre-menopausal state
- •Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
- •Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first vaginal ring insertion)
- •Normal pap test result on file at Altasciences in the previous 12 months prior to the first vaginal ring insertion or normal pap test result at Screening
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including breast and gynecological examination) and/or electrocardiogram (ECG), as determined by an Investigator
排除标准
- •Female who is lactating
- •Female who is pregnant according to the pregnancy test at Screening or prior to the first vaginal ring insertion
- •Use of the following systemic contraceptives: oral, patch, or vaginal ring, in the 28 days prior to the first vaginal insertion and until completion of the study
- •Use of hormone replacement therapy in the 28 days prior to the first vaginal insertion and until completion of the study
- •Use of the following systemic contraceptives: injections or implant, or hormone-releasing intrauterine device (IUD) in the 13 weeks prior to the first vaginal insertion and until completion of the study
- •Has contraindication for contraceptive steroids
- •Post-menopausal status (minimum of a year without menses) and/or has undergone a complete hysterectomy or bilateral oophorectomy
- •Seated blood pressure higher than 140/90 mmHg at the Screening visit and prior to the first vaginal ring insertion, unless deemed non-significant by an Investigator
- •History of significant hypersensitivity to ethinyl estradiol, etonogestrel, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Presence or history of significant genital, gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease, as defined by the Investigator
- •Presence of clinically significant ECG abnormalities at the Screening visit, as defined by the Investigator
- •Known presence or history of thrombophlebitis or any thromboembolic disorders (eg, venous thrombosis, arterial thrombosis), with or without pulmonary embolism
- •Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C-resistance (including Factor V Leiden), antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
- •Known presence or history of classic migraine
- •Known presence of ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields
- •Known presence, suspected presence or history of cervical, breast, uterine, estrogen-dependent, or progestin-dependent cancer or other sex-steroid sensitive malignancies
- •Known presence or history of undiagnosed abnormal vaginal bleeding
- •Known presence of any condition that makes the use of the vaginal ring difficult such as prolapse of the uterine cervix, cystocele, and/or rectocele, severe or chronic constipation
- •Any other vaginal condition that would interfere with the vaginal ring or cause an increased health risk
- •Scheduled immunization with a Coronavirus Disease 2019 (COVID-19) vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason
- •Major surgery with prolonged immobilisation in the previous 6 months prior to the first vaginal ring insertion
- •Planned major elective surgery in the 3 months following removal of the vaginal ring
- •Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- •Any clinically significant illness in the 28 days prior to the first vaginal ring insertion
- •Use of any prescription drugs in the 28 days prior to the first vaginal ring insertion, that in the opinion of an Investigator would put into question the status of the participant as healthy
- •Use of St. John's wort in the 28 days prior to the first vaginal ring insertion
- •Any history of tuberculosis
- •Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first vaginal ring insertion
- •Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or hepatitis C virus tests
- •Serum ferritin value below 24 μg/L at Screening
- •Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
- •Inclusion in a previous group for this clinical study
- •Intake of ethinyl estradiol or etonogestrel in the 28 days prior to the first vaginal ring insertion
- •Intake of an IP in the 28 days prior to the first vaginal ring insertion
- •Donation of 50 mL or more of blood in the 28 days prior to the first vaginal ring insertion
- •Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first vaginal ring insertion
- •Hemoglobin laboratory values below the lower limit of the reference at Screening -
结局指标
主要结局
Bioequivalence: evaluate and compare the bioavailability and therefore to assess the bioequivalence of 2 different formulations of ethinyl estradiol/etonogestrel vaginal ring
时间窗: Up to 24 days post ring insertion per period
The primary study endpoints are the pharmacokinetic (PK) parameter is the Cmax.
次要结局
- Safety and tolerability of the vaginal rings(through study completion, expected 102 days)
- Evaluate the vaginal local irritation and occurrence of bleeding/spotting(through study completion, expected 102 days)
研究者
研究点 (1)
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