Moderate to severe primary dysmenorrhea MedDRA version: 19.0 Level: LLT Classification code 10062851 Term: Primary dysmenorrhea System Organ Class: 100000004872 MedDRA version: 19.0 Level: LLT Classification code 10013934 Term: Dysmenorrhea System Organ Class: 100000004872
Conditions
Interventions
Product Name: ENG-E2 vaginal ring
Product Code: MK-8342B
Pharmaceutical Form: Vaginal delivery system
INN or Proposed INN: Etonogestrel
CAS Number: 54048-10-1
Current Sponsor code: MK-8342
Other descr
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In women with moderate to severe primary dysmenorrhea: 1. To evaluate the efficacy of the ENG-E2 vaginal ring relative to placebo in the treatment of dysmenorrhea at Treatment Cycle 2. 2. To assess the safety and tolerability of the ENG-E2 vaginal ring over 4 treatment cycles.;Secondary Objective: In women with moderate to severe primary dysmenorrhea, to assess the effect of treatment with the ENG-E2 vaginal ring relative to placebo at Treatment Cycle 2 on: 1. The change from baseline in the peak pelvic pain score. 2. The number of days with no impact of dysmenorrhea (score = 0) on each of the following DysDD items separately: work/school, physical activities, and social or leisure activities. 3. The proportion of subjects with no or minimal pain (i.e. peak pelvic pain score of “0” or “1”) and no use of ibuprofen tablets. 4. The proportion of subjects with a =3 point reduction in peak pelvic pain score and a decrease in the number of ibuprofen tablets as compared to baseline. 5. The change from baseline in the mean pelvic pain score.;Primary end point(s): The primary endpoint of this study is a composite responder endpoint defined as the proportion of subjects with a reduction in peak pelvic pain score of at least 3 points (item #2 of the Dysmenorrhea Daily Diary, and no increase in the use of rescue pain relief medication (total number of ibuprofen 400 mg tablets taken) at Treatment Cycle 2 as compared to baseline.;Timepoint(s) of evaluation of this end point: The main assessment of the primary endpoint is performed at Treatment cycle 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline cycle in the peak pelvic pain score. 2. Change from baseline cycle in the number of days with no impact (score = 0) of dysmenorrhea on each of the DysDD items, separately: physical activities, social or leisure activities, and work/school. 3. Proportion of subjects with pelvic pain score of "0" or "1" and no use of ibuprofen tablets. 4. Proportion of subjects with reduction in peak pelvic pain score of at least 3 points and a decrease in number of ibuprofen tablets taken. 5. Change from baseline cycle in the mean pelvic pain score.;Timepoint(s) of evaluation of this end point: The main assessment of the secondary endpoints are performed at Treatment cycle 2. | — |
Countries
Chile, Guatemala, Italy, Poland, Puerto Rico, Russian Federation, South Africa, Sweden, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck
Outcome results
None listed