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

Organon

Status and phase: Completed; Phase 3

Conditions: Dysmenorrhea

Treatments: Drug: etoricoxib (MK0663); Drug: Comparator: placebo (unspecified); Drug: Comparator: naproxen sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092729

0663-064

2004_053

MK0663-064

Details and patient eligibility

About

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).

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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129 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

etoricoxib

Treatment:

Drug: etoricoxib (MK0663)

2

Placebo Comparator group

Description:

Placebo to match etoricoxib

Treatment:

Drug: Comparator: placebo (unspecified)

3

Active Comparator group

Description:

naproxen sodium

Treatment:

Drug: Comparator: naproxen sodium