EUCTR2015-004326-34-PL进行中（未招募）1 期
A Phase 3 Randomized, Double-blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 vaginal ring) in Women with Moderate to Severe Primary Dysmenorrhea.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •In order to be eligible for participation in this trial, the subject must:
- •1. Provide written informed consent/assent for the trial. Provide consent/assent if agreeing to participate in sample collection for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •2. Be a post-menarcheal female, age =50 years.
- •3. Have a history of moderate to severe primary dysmenorrhea for the past 3 months or longer, and no history of recurrent non-menstrual pelvic pain intermittently or continuously throughout the month, and no history of dysmenorrhea secondary to structural pelvic pathology (e.g., endometriosis, fibroids, pelvic inflammatory disease, adenomyosis). Subjects with a history of mid-cycle discomfort with ovulation (mittelschmerz) may participate.
- •4. Have a body mass index (BMI) of =18 and <38 kg/m2.
- •5. If heterosexually active, agrees to consistently use male condoms as the contraceptive method starting the day of Visit 1, and during the entire treatment period (until 14 days after removal of the last study ring) unless her partner is surgically sterilized. Sporadic use of an emergency contraceptive (EC) is not an exclusion; however, the
- •investigator should carefully assess subject’s ability to comply with the protocol requirements for condom use.
- •6. Has a history of regular menstrual cycles with a cycle length between 24 and 32 days (inclusive) for the past three months.
- •7. Be in good physical and mental health, based upon the medical judgment of the investigator
- •8. Be able and willing (in the opinion of the investigator) to adhere to use of the vaginal ring and to all required trial procedures, including study visits and use of daily eDiary, and not planning to relocate during the study (such that the subject would not be able to continue participation at the trial site).
- •9. Be willing to use the rescue medication ibuprofen at the study recommended dose (provided by the study site) and no other pain medication for treatment of dysmenorrhea.
- •Additional inclusion criteria to be verified at Visit 3:
- •10. Have demonstrated a menstrual cycle length between 24 and 32 days (inclusive) in the eDiary during the screening period (1st spontaneous menses during screening period (SM1) to 2nd spontaneous menses during screening period (SM2)).
- •11. Have demonstrated moderate to severe dysmenorrhea during the screening period as defined by a peak menstrual cramping pain score =6 on item #2 of the Dysmenorrhea Daily Diary during both SM1 and SM2.
- •12. Have no more than 3 days with incomplete eDiary entries during the screening period and no more than one day with incomplete entries during SM2.
- •13. Have demonstrated compliance with taking only the study provided ibuprofen tablets for dysmenorrhea during SM1 and SM2 as evidence in the eDiary.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Has a personal history of VTE (deep vein thrombosis, pulmonary embolism) or history of ATE events (i.e., myocardial infarction, stroke, or peripheral arterial), or history of transient ischemic attack or angina pectoris or claudication.
- •- Is at a higher risk of VTE events due to recent prolonged immobilization (within 2 weeks prior to screening, e.g., due to trauma, surgery, or other illness markedly limiting mobility, planned surgery limiting mobilization, or has a hereditary or acquired predisposition or elevated risk for venous or arterial thrombosis, such as APC (activated protein C) resistance, antithrombin-III-deficiency, protein C
- •deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) or has thrombogenic cardiac valve or rhythm abnormalities of the heart associated with thromboembolism (e.g., atrial fibrillation).
- •- Is currently smoking or uses tobacco/nicotine containing products and is =35 years of age.
- •- Has a history of severe dyslipoproteinemia.
- •- Is <35 years of age and has a history of migraine with aura or focal neurological symptoms; or is =35 years of age and has a history of migraines (with or without aura or focal neurologic symptoms).
- •- Has diabetes mellitus with end-organ involvement (nephropathy, retinopathy, neuropathy or other vascular involvement) or has had diabetes for >20 years duration.
- •- Has multiple cardiovascular risk factors such as older age (>35 years), obesity (BMI >30 kg/m2), inadequately controlled hypertension, use of tobacco/ nicotine products, or inadequately controlled diabetes which, in the opinion of the investigator, in composite pose an unacceptable risk of study participation. The investigator should consider the severity of each risk factor in determining whether study participation is appropriate.
- •- Has a known or suspected pregnancy.
- •- Has been pregnant or breastfeeding within the past 2 months.
- •- Has used hormonal contraceptives (pill, patch, ring, implant, intrauterine system) within the past 3 months.
- •- Current use of non-hormonal intrauterine device (IUD). To qualify, device must be discontinued before V1 and the diagnosis of primary dysmenorrhea must have preceded IUD insertion.
- •- Within the past 6 months has had undiagnosed (unexplained) abnormal vaginal bleeding or any other abnormal bleeding that is expected to recur during the study (e.g., bleeding from a cervical polyp, recurrent bleeding after intercourse).
- •- Currently has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis. Subjects may be rescreened 3 weeks after completing treatment for these conditions.
- •- Has an abnormal cervical smear or positive high-risk human papilloma virus (HPV) test at screening or documented within 3 years of screening.
- •- 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.
- •- Has a history of pancreatitis associated with severe hypertriglyceridemia.
- •- Has clinically significant liver disease, including active viral hepatitis or cirrhosis.
- •Subjects with a prior history of liver disease which is now inactive or successfully treated may be enrolled if liver function values (AST, ALT, total bilirubin) have been normal for the past year and are within the normal range (per central lab) at V1.
- •- Has history of conditions of the gastrointestinal or u
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