The purpose of this study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in premenopausal female participants with moderate to severe endometriosis-related pain. The primary hypothesis: gefapixant is superior to placebo in reducing the average daily pelvic pain score (cyclic and non-cyclic, combined) during Treatment Cycle 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
187
Gefapixant tablet 45 mg taken orally
Placebo matching gefapixant tablet taken orally
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
Pelvic pain (cyclic pain associated with menses, and non-cyclic pain not associated with menses) severity score was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The averages of the daily pelvic pain scores (cyclic and non-cyclic, combined) entered in participants' electronic diaries (eDiaries) were calculated for Baseline and Treatment Cycle 2 (approximately Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline.
Time frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Percentage of Participants Who Experienced an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, this analysis included AEs reported up to 14 days after end of study intervention.
Time frame: Up to approximately 10 weeks
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 8 weeks
Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
Cyclic pelvic pain (associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the daily cyclic pelvic pain scores entered in participants' eDiaries was calculated for Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline.
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Cahaba Medical Care ( Site 0750)
Birmingham, Alabama, United States
Synexus US Phoenix Southeast ( Site 0729)
Chandler, Arizona, United States
Synexus ( Site 0734)
Scottsdale, Arizona, United States
Lynn Institute of the Ozarks ( Site 0720)
Little Rock, Arkansas, United States
California Center for Clinical Research ( Site 0741)
Arcadia, California, United States
Artemis Institute for Clinical Research ( Site 0716)
San Diego, California, United States
Alta California Medical Group ( Site 0721)
Simi Valley, California, United States
Thameside OBGYN Center ( Site 0747)
Groton, Connecticut, United States
WHUSA Fine and Gillette ( Site 0751)
Hamden, Connecticut, United States
Florida Fertility Institute ( Site 0737)
Clearwater, Florida, United States
...and 68 more locations
Time frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
Non-cyclic pelvic pain (not associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the non-cyclic daily pelvic pain scores entered in participants' eDiaries was calculated for the Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates decrease in pain severity from baseline.
Time frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)