A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-R… (NCT03654326) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
United States, Australia, Chile187 participantsStarted 2018-09-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis.
* has cyclic AND non-cyclic, moderate to severe endometriosis-related pelvic pain (overall pelvic pain score ≥5 using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain).
* has had spontaneous menstrual cycles before Visit 1.
* has body mass index (BMI) between 18 kg/m\^2 to 40 kg/m\^2 at Visit 1.
* is not pregnant, not breastfeeding, and agrees to follow the contraceptive guidance.
* must agree to switch from her usual analgesic medication to only that which is permitted in the study.
Exclusion Criteria:
* history of hysterectomy and/or bilateral oophorectomy.
* has undiagnosed vaginal bleeding.
* has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic.
* has a clinically significant gynecologic condition identified in the screening evaluation.
* has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs.
* has a known allergy/sensitivity or contraindication to gefapixant or its excipients.
* has an allergy/sensitivity/intolerance to naproxen sodium (rescue medication) or any contraindication to its use, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
* has a history of endometriosis-related pain that was non-respo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
Timeframe: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
2
Percentage of Participants Who Experienced an Adverse Event
Timeframe: Up to approximately 10 weeks
3
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event