Skip to main content
OpenTrials
Completed

NCT Number: NCT00092729

An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 18 years of age or older suffering from painful menstruation

Exclusion criteria

  • Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives).
  • Women who are pregnant, breast-feeding or within 6 weeks of giving birth

Treatment and study plan

etoricoxib (MK0663)

Drug

Two etoricoxib 60 mg tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea

Other names: MK0663

Comparator: Placebo (Unspecified)

Drug

Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg placebo tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea

Comparator: naproxen sodium

Drug

Two etoricoxib 60 mg placebo tablets and one naproxen sodium 550 mg tablet, single-dose, following onset of moderate-to-severe pain due to primary dysmenorrhea

Other names: naproxen sodium

Primary outcomes

  1. Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo

    Time frame: Up to 8 hours postdose and at 8 and 24 hours postdose, following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles

  2. Time to onset, peak, and duration of the analgesic effect compared with placebo

    Time frame: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles

Secondary outcomes

  1. Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium

    Time frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles

  2. Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo

    Time frame: Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles

  3. Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences

    Time frame: From randomization through 14 days following the last dose of study medication

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Sep 28, 2004
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.