Conditions: Dysmenorrhea
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 139
Healthy volunteers: no

Brief summary:
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Detailed description:
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.

In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.

Arms:
arm 1: Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2. arm 2: Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.

Interventions: intervention 1: Etoricoxib intervention 2: Ibuprofen intervention 3: Placebo to etoricoxib intervention 4: Placebo to ibuprofen intervention 5: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg
Intervention descriptions: intervention 1: Etoricoxib 120 mg tablet given orally for one dose. intervention 2: Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day. intervention 3: Placebo to etoricoxib, one tablet. intervention 4: Placebo to ibuprofen, up to four 3-capsule doses. intervention 5: Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.

Protocol document: