A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 900 μg Nomegestrol Acetate (NOMAC) and 300 μg Estradiol (E2), or 100 μg Etonogestrel (ENG) and 300 μg E2, or 125 μg Etonogestrel (ENG) and 300 μg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 439
- 主要终点
- Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2
研究概览
简要总结
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea.
详细描述
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea. The intake of ibuprofen rescue medication and the impact on daily life is investigated: change from baseline data of these two variables will be compared between each of the four active ring groups, separately, and the placebo ring group. Furthermore, the study assesses the measurement characteristics and psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding pattern and general safety and tolerability will also be evaluated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥18 and ≤35
- •Established diagnosis of primary dysmenorrhea
- •If of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit, unless she or her partner are surgically sterilized
- •Agree to stop using hormonal contraceptive (combined or progestin-only), or a non hormonal intrauterine device (IUD)
- •Regular menstrual cycles ranging from 24 to 35 days in length
排除标准
- •Any of the following contraindications to the use of contraceptive steroids including: presence or a history of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident (stroke, history of migraine with focal neurological symptoms, diabetes mellitus with vascular involvement, severe or multiple risk factor(s) for venous or arterial thrombosis, severe dyslipoproteinemia, severe hypertension, pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, presence or history of severe hepatic (liver) disease, including benign or malignant tumors, known or suspected sex steroid-influenced malignancies, and/or undiagnosed vaginal bleeding
- •Pregnant or breastfeeding
- •Secondary dysmenorrhea
- •Has not had spontaneous menstruation following a delivery or abortion
- •Participated in an investigational drug study within 30 days
- •History of malignancy ≤5 years
- •Documented abnormal cervical smear result within 6 months
- •Use of recreational or illicit drugs
- •Consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
- •Allergy/sensitivity to ibuprofen, or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, or other nonsteroidal anti inflammatory drugs
- •Has been sterilized using a fallopian tube occlusion device
- •Is receiving, or has received sex hormones for any purpose other than contraception within 2 months or injectable hormonal contraception within 6 months
研究组 & 干预措施
NOMAC-E2 700/300 mcg
NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) (Drug)
NOMAC-E2 700/300 mcg
NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Ibuprofen (Drug)
NOMAC-E2 900/300 mcg
NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) (Drug)
NOMAC-E2 900/300 mcg
NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Ibuprofen (Drug)
ENG-E2 100/300 mcg
ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Etonogestrel containing contraceptive vaginal ring (ENG-CVR) (Drug)
ENG-E2 100/300 mcg
ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Ibuprofen (Drug)
ENG-E2 125/300 mcg
ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Etonogestrel containing contraceptive vaginal ring (ENG-CVR) (Drug)
ENG-E2 125/300 mcg
ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Ibuprofen (Drug)
Placebo
Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Placebo (Drug)
Placebo
Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2
时间窗: Baseline and Day 29 to 56 (Cycle 2)
The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: "Cramps") in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe).
次要结局
- Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2(Baseline and Day 29 to 56 (Cycle 2))
- Change From Baseline in Total Mean Impact Score Through Cycle 2(Baseline and Day 29 to 56 (Cycle 2))
- Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2(Baseline and Day 29 to 56 (Cycle 2))