EUCTR2015-005284-16-AT进行中（未招募）1 期
A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Pharmacodynamics of Etonogestrel (ENG) and 17ß-Estradiol (E2) in Healthy female Postmenarcheal Adolescents and Healthy Female Adults Following Administration of MK-8342B (ENG-E2, 125/300 µg/day) Vaginal Ring
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Healthy female either postmenarcheal adolescents =12 to <18 years of age at screening or adults of childbearing potential between =18 to =36 years of age at screening.
- •2. Regular menstrual cycles = 21 to = 35 days in length in the 3 months prior to screening
- •3. Continuous non smokers who have not used nicotine containing products for at least 3 months prior to the first vaginal ring insertion.
- •4. BMI = 17.5 and = 29.0kg/m2 at screening.
- •5. Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or ECGs, as deemed by the Investigator.
- •6. Able and willing to stop hormonal contraceptive, including oral contraceptives, transdermal contraceptive patches, implants and intrauterine device (IUD) - if used 28 days prior to first viginal ring cycle; or depot injections - if used 90 days prior to the first vaginal ring cycle.
- •7. If sexually active agrees to use condom without spermicide during the screening phase and the follow-up phase of the study/during the entire duration of the study.
- •8. If = 18 years old at study entry or turning 18 during study participation - normal cervical Pap test within 24 months documented at the time of screening. If not - Pap test must be performed at screening with normal result.
- •9. Able to understand and willing to comply with the protocol. Able to understand and willing to sign the informed consent form. For adolescent subjects, a parental ICF is also required.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
- •2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator
- •3. History of any illness that, in the Investigator's opinion, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- •4. History or presence of alcoholism or drug abuse within the past 2 years, prior to vaginal ring insertion
- •5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
- •6. History or presence of: venous thromboembolic events (VTE), arterial thromboembolic events (ATE), and other major adverse cardiovascular events (MACE) (e.g., myocardial infarction, cerebral vascular accident); migraines or severe headaches; breast cancer or undiagnosed breast nodules; hypertension; transient ischemic attacks; liver tumors or liver disease; jaundice with previous use of oral contraceptives or past pregnancy; diabetes; pancreatitis or severe hypertriglyceridemia; carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia;
- •family history of 1st degree relative with breast or ovarian cancer; cervical cancer, or cervical procedures including loop electrosurgical excision procedure or conization (i.e., cold knife cone biopsy from the mucous membrane of the cervix); any condition that would contraindicate the use of hormonal contraceptives
- •7. Positive pregnancy test or lactating
- •8. Abnormal cervical Pap test within 1 year prior to screening.
- •9. Within the past 6 months of first vaginal ring insertion, has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal bleeding that is expected to recur during the study (e.g., bleeding from cervical polyp, bleeding after sex).
- •10. Has stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees of prolapse with a history of difficulty retaining tampons, vaginal rings, or other products within the vagina
- •11. Clinically significant abnormalities of the genital organs as determined by a gynecologist and based on the Investigator’s judgment
- •12. Has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis. Subjects may be rescreened 3 weeks after completing treatment for these conditions
- •13. Positive results for the urine drug and/or alcohol screen at screening or each check in
- •14. Drink alcohol in excess of 14 glasses/units per week (1 unit = 125 mL of wine or 284 mL of beer or 25 mL of 45% alcohol)
- •15. Positive urine cotinine at screening (threshold >10 ng/mL). Note: subjects may be retested at screening if positive.
- •16. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •17. Unable to refrain from or anticipates the use of:
- •Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first vaginal ring cycle and throughout the study. Paracetamol (up to 2 g per 24 hours) may be permitted for minor ailments (e.g., in case of menstrual pain, sunburn, fever).
- •Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John’s wort, for 28 days prior to the first vaginal ring cycle and throughout the study. Appropriate sources will be consulted by the Investigator or d
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