A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
NCT ID: NCT03654326
Last Updated: 2024-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2018-09-11
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gefapixant
Participants will receive a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets will also be provided to participants for use as rescue medication for endometriosis-related pain.
Gefapixant
Gefapixant tablet 45 mg taken orally
Placebo
Placebo matching gefapixant tablet taken orally
Naproxen
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Placebo
Participants will receive a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets will also be provided to participants for use as rescue medication for endometriosis-related pain.
Placebo
Placebo matching gefapixant tablet taken orally
Naproxen
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Interventions
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Gefapixant
Gefapixant tablet 45 mg taken orally
Placebo
Placebo matching gefapixant tablet taken orally
Naproxen
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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
Corpus Christi Clinic ( Site 0744)
Corpus Christi, Texas, United States
HD Research Corp ( Site 0738)
Houston, Texas, United States
PI-Coor Clinical Research, LLC ( Site 0710)
Reston, Virginia, United States
Clinical Research Partners, LLC. ( Site 0704)
Richmond, Virginia, United States
Seattle Women's: Health, Research, Gynecology ( Site 0714)
Seattle, Washington, United States
Paratus Clinical Kanwal ( Site 0004)
Kanwal, New South Wales, Australia
Royal Hospital for Women ( Site 0008)
Randwick, New South Wales, Australia
Holdsworth House Medical Practice ( Site 0009)
Sydney, New South Wales, Australia
Royal Adelaide Hospital ( Site 0007)
Adelaide, South Australia, Australia
Keogh Institute for Medical Research ( Site 0002)
Nedlands, Western Australia, Australia
Hospital San Juan de Dios de La Serena ( Site 0110)
La Serena, Coquimbo Region, Chile
Hospital San Borja Arriaran ( Site 0103)
Santiago, Santiago Metropolitan, Chile
Clinica Indisa [Santiago, Chile] ( Site 0101)
Santiago, , Chile
Clinica Las Condes ( Site 0109)
Santiago, , Chile
Clinica Alemana de Santiago ( Site 0107)
Santiago, , Chile
Southern Clinical Trials - Waitemata ( Site 0200)
Auckland, , New Zealand
Southern Clinical Trials Ltd ( Site 0201)
Christchurch, , New Zealand
Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
Bialystok, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
Katowice, , Poland
SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)
Katowice, , Poland
Clinical Medical Research Sp. z o.o. ( Site 0343)
Katowice, , Poland
Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
Katowice, , Poland
LIFTMED ( Site 0325)
Rybnik, , Poland
Examen Sp. z o.o. ( Site 0318)
Skorzewo, , Poland
Clinical Best Solutions ( Site 0338)
Warsaw, , Poland
Marek Elias Gabinety Ginekologiczne ( Site 0331)
Wroclaw, , Poland
Cooperativa de Facultad Medica Sanacoop ( Site 0805)
Bayamón, , Puerto Rico
Ponce Health Sciences University ( Site 0804)
Ponce, , Puerto Rico
Gynecology & Endometriosis Center LLC ( Site 0806)
San Juan, , Puerto Rico
Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
San Juan, , Puerto Rico
Genes Fertility Institute Inc. ( Site 0803)
San Juan, , Puerto Rico
Kazan State Medical University ( Site 0404)
Kazan', , Russia
Clinical Hospital #2 of Kazan city ( Site 0406)
Kazan', , Russia
LLC Scientific Research Medical Complex Your Health. ( Site 0405)
Kazan', , Russia
Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
Moscow, , Russia
State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
Moscow, , Russia
Women clinic 22 ( Site 0400)
Saint Petersburg, , Russia
NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
Saint Petersburg, , Russia
Uromed LLC ( Site 0410)
Smolensk, , Russia
Siberian State Medical University ( Site 0402)
Tomsk, , Russia
Hospital Sanitas La Zarzuela ( Site 0502)
Aravaca, Madrid, Spain
Instituto de Ciencias Medicas.ICM ( Site 0500)
Alicante, , Spain
Hospital Clinic i Provincial de Barcelona ( Site 0501)
Barcelona, , Spain
Hospital Sanitas La Moraleja ( Site 0504)
Madrid, , Spain
Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
Ivano-Frankivsk, , Ukraine
Medical Center Verum ( Site 0900)
Kyiv, , Ukraine
GI Institute of POG of NAMS of Ukraine ( Site 0905)
Kyiv, , Ukraine
City Clinical Hospital No. 9 ( Site 0901)
Kyiv, , Ukraine
Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
Odesa, , Ukraine
Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
Ternopil, , Ukraine
Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
Zaporizhzhya, , Ukraine
Communal Institution Maternity Hospital 3 ( Site 0909)
Zaporizhzhya, , Ukraine
Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)
Zaporizhzhya, , Ukraine
Countries
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References
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Arbelaez F, Joeng HK, Hussain A, Sunga S, Guan Y, Chawla A, Carmona F, Lines C, Mendizabal G. Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain. Fertil Steril. 2025 Feb;123(2):280-288. doi: 10.1016/j.fertnstert.2024.09.013. Epub 2024 Sep 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MK-7264-034
Identifier Type: OTHER
Identifier Source: secondary_id
2018-001098-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7264-034
Identifier Type: -
Identifier Source: org_study_id
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