Phase 2
N=439
A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01670656 ↗Enrolled (actual)
439
Serious AEs
0.5%
Results posted
Aug 2017
Primary outcome: Primary: Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2 — -1.7; -1.7; -1.9; -1.7 Units on a scale — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) (Drug); Etonogestrel containing contraceptive vaginal ring (ENG-CVR) (Drug); Placebo (Drug); Ibuprofen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2 |
-1.7; -1.7; -1.9; -1.7; -1.2 | < 0.001 sig |
| SECONDARY Change From Baseline in Total Mean Impact Score Through Cycle 2 |
-4.8; -5.0; -4.7; -4.3; -3.1 | = 0.002 sig |
| SECONDARY Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2 |
-6.4; -6.3; -7.1; -6.0; -4.8 | = 0.026 sig |
| SECONDARY Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2 |
-1.3; -1.7; -1.7; -1.4; -1.1 | = 0.447 |
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
Data sourced from ClinicalTrials.gov (NCT01670656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.