There are limited treatment options for management of dysmenorrhea, and the physiological
processes they affect are not completely understood. For example, NSAIDs are effective in
reducing menstrual pain in some women by inhibition of prostaglandin synthesis, but whether
those effects are mediated by affecting contractility, perfusion, or hypoxemia is unknown.
Understanding how these drugs relieve menstrual pain (and why they fail) would be of
substantial clinical significance. Given the foregoing, Two Specific Aims are proposed:
Aim #1: Characterize menstrual pain phenotypes associated with impairments in myometrial
activity, perfusion, and/or oxygenation. Continuous MRI scans of the uterus will be performed
with simultaneous measurement of self-reported pain in healthy women and those experiencing
menstrual pain. The investigators will include cohorts of women with imaging diagnosed
leiomyoma and surgically-confirmed endometriosis to evaluate the contribution of structurally
identifiable factors. Based on preliminary data, the investigators anticipate finding four
phenotypes with menstrual pain related to: 1) myometrial activity, 2) inadequate perfusion
and/or oxygenation, 3) a combination of phenotypes 1 & 2, and 4) a non-uterine source.
Aim #2: Evaluate the effects of naproxen on myometrial activity, perfusion, and/or
oxygenation with respect to pain relief. In women with primary dysmenorrhea, the
investigators will acquire pelvic MRI scans and evaluate self-reported menstrual cramping
pain before and after administration of randomized naproxen or placebo.
Naproxen could principally affect one or more potential sources of uterine pain such as
myometrial activity, perfusion, and/or oxygenation. The investigators will corroborate
preliminary data findings, which suggest menstrual phenotypes with myometrial activity will
be more likely to respond. Conversely, Aim 2 will also elucidate the mechanisms responsible
for inadequate pain relief from naproxen.
Bioavailability of naproxen levels and other molecules associated with NSAID-resistance will
be evaluated from the serum of participants after taking naproxen using HPLC-MS.
Phase:
Phase 4
Details
Lead Sponsor:
NorthShore University HealthSystem
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH)