A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR); Etonogestrel containing contraceptive vaginal ring (ENG-CVR); Placebo; Ibuprofen
Intervention description: Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles; Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles; Placebo to match vaginal ring, intravaginally for two 28-day cycles; Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)
Intervention MeSH terms: Ibuprofen; Contraceptive Agents; Etonogestrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 439.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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