A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometriosis-related Pain

In brief

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.

Key facts

Study ID

NCT03654326

Run by

Merck Sharp & Dohme LLC

People needed

187

Starts

2018-09-11

Expected to finish

2020-06-30

Last updated by the study team

2024-11-04

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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-responsive to treatment with combined hormonal contraceptives (CHCs), gonadotropin-releasing hormone (GnRH) antagonists, GnRH agonists, progestins, or aromatase inhibitors.
• has a positive urine pregnancy test at any time before randomization.
• has required more than 2 weeks of continuous use of narcotics for treatment of endometriosis-related pain within 6 months of Visit 1.

Where it is running

• 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
• Advanced Pharma Research ( Site 0719) — Cutler Bay, Florida, United States
• Doral Medical Research, LLC ( Site 0706) — Doral, Florida, United States
• KO Clinical Research, LLC ( Site 0723) — Fort Lauderdale, Florida, United States
• Well Pharma Medical Research, Corp. ( Site 0703) — Miami, Florida, United States
• L&C Professional Medical Research Institute ( Site 0709) — Miami, Florida, United States
• New Horizon Research Center ( Site 0717) — Miami, Florida, United States
• Inpatient Research Clinic, LLC ( Site 0725) — Miami Lakes, Florida, United States
• QPS Miami Research Associates ( Site 0735) — South Miami, Florida, United States
• Lenus Research & Medical Group Llc ( Site 0702) — Sweetwater, Florida, United States
• Southern Clinical Research Associates ( Site 0701) — Metairie, Louisiana, United States
• Tufts Medical Center ( Site 0742) — Boston, Massachusetts, United States
• Carolina Women's Research and Wellness Center ( Site 0715) — Durham, North Carolina, United States
• Palmetto Clinical Research ( Site 0707) — Summerville, South Carolina, United States
• Chattanooga Medical Research ( Site 0743) — Chattanooga, Tennessee, United States
• Women Partners in Health ( Site 0745) — Austin, Texas, United States
• Cahaba Medical Care ( Site 0750) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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