A multicenter, randomized, partially blinded, placebo-controlled clinical trial to evaluate the effect on primary dysmenorrheal 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

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: This study will investigate the use of 4 doses of combined contraceptives (a progestin with an estrogen) in a vaginal ring dosage form for the treatment of dysmenorrhea (menstrual cramping pain). A placebo control arm will also be utilized.
发起方: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
入组人数: 439
状态: 进行中（未招募）
最后更新: 6年前

暂无简介。

注册库

who.int

开始日期

2012年9月3日

结束日期

2013年9月12日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

•1\. Subject must be willing and able to provide written informed consent for the trial.
•2\. Subject must be female.
•3\. Subject must be ?18 to ?50 years of age.
•4\. Subject must have a body mass index (BMI) \=18 and \=35\.
•5\. Subject must have an established diagnosis of primary dysmenorrhea, characterized by menstrual pain in the absence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
•6\. Each non\-sterilized sexually active subject 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.
•7\. Subject using a hormonal contraceptive (combined or progestin\-only), or a non\-hormonal IUD, at the screening visit must agree to stop using that method.
•8\. Subject has regular menstrual cycles ranging from 24 to 32 days in length (to be confirmed at the randomization visit following completion of a baseline menstrual cycle).
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Subject has any contraindication to the use of contraceptive steroids.
•2\. Subject has secondary dysmenorrhea – ie, menstrual pain in the presence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
•3\. Subject has not had spontaneous menstruation following a delivery or abortion at the screening visit.
•4\. The subject is breastfeeding or has not had spontaneous menstruation following completion of breastfeeding at the screening visit.
•5\. Subject has a history of malignancy \=5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
•6\. Subject had a documented abnormal cervical smear result within 6 months prior to the screening visit.
•7\. Subject routinely consumes \>2 alcoholic drinks per day or \>14 alcoholic drinks per week, or engages in binge drinking.