Clinical trial NCT03654326: A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
Official title: A Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis-related Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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-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.

Primary outcomes:
measure: 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)
measure: Percentage of Participants Who Experienced an Adverse Event
timeFrame: Up to approximately 10 weeks
measure: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to approximately 8 weeks
Secondary outcomes:
measure: Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
timeFrame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
measure: Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
timeFrame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Medical Care ( Site 0750)
state: Alabama
city: Chandler
country: United States
facility: Synexus US Phoenix Southeast ( Site 0729)
state: Arizona
city: Scottsdale
country: United States
facility: Synexus ( Site 0734)
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks ( Site 0720)
state: Arkansas
city: Arcadia
country: United States
facility: California Center for Clinical Research ( Site 0741)
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research ( Site 0716)
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group ( Site 0721)
state: California
city: Groton
country: United States
facility: Thameside OBGYN Center ( Site 0747)
state: Connecticut
city: Hamden
country: United States
facility: WHUSA Fine and Gillette ( Site 0751)
state: Connecticut
city: Clearwater
country: United States
facility: Florida Fertility Institute ( Site 0737)
state: Florida
city: Cutler Bay
country: United States
facility: Advanced Pharma Research ( Site 0719)
state: Florida
city: Doral
country: United States
facility: Doral Medical Research, LLC ( Site 0706)
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC ( Site 0723)
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinic, LLC ( Site 0725)
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp. ( Site 0703)
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute ( Site 0709)
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center ( Site 0717)
state: Florida
city: South Miami
country: United States
facility: QPS Miami Research Associates ( Site 0735)
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group Llc ( Site 0702)
state: Florida
city: Metairie
country: United States
facility: Southern Clinical Research Associates ( Site 0701)
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center ( Site 0742)
state: Massachusetts
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center ( Site 0715)
state: North Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research ( Site 0707)
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research ( Site 0743)
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health ( Site 0745)
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Clinic ( Site 0744)
state: Texas
city: Houston
country: United States
facility: HD Research Corp ( Site 0738)
state: Texas
city: Reston
country: United States
facility: PI-Coor Clinical Research, LLC ( Site 0710)
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC. ( Site 0704)
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology ( Site 0714)
state: Washington
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal ( Site 0004)
state: New South Wales
city: Randwick
country: Australia
facility: Royal Hospital for Women ( Site 0008)
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice ( Site 0009)
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 0007)
state: South Australia
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research ( Site 0002)
state: Western Australia
city: La Serena
country: Chile
facility: Hospital San Juan de Dios de La Serena ( Site 0110)
state: Region De Coquimbo
city: Santiago
country: Chile
facility: Hospital San Borja Arriaran ( Site 0103)
state: Region Metropolitana
city: Santiago
country: Chile
facility: Clinica Indisa [Santiago, Chile] ( Site 0101)
city: Santiago
country: Chile
facility: Clinica Las Condes ( Site 0109)
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago ( Site 0107)
city: Auckland
country: New Zealand
facility: Southern Clinical Trials - Waitemata ( Site 0200)
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Ltd ( Site 0201)
city: Bialystok
country: Poland
facility: Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
city: Katowice
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
city: Katowice
country: Poland
facility: SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)
city: Katowice
country: Poland
facility: Clinical Medical Research Sp. z o.o. ( Site 0343)
city: Katowice
country: Poland
facility: Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
city: Rybnik
country: Poland
facility: LIFTMED ( Site 0325)
city: Skorzewo
country: Poland
facility: Examen Sp. z o.o. ( Site 0318)
city: Warszawa
country: Poland
facility: Clinical Best Solutions ( Site 0338)
city: Wroclaw
country: Poland
facility: Marek Elias Gabinety Ginekologiczne ( Site 0331)
city: Bayamon
country: Puerto Rico
facility: Cooperativa de Facultad Medica Sanacoop ( Site 0805)
city: Ponce
country: Puerto Rico
facility: Ponce Health Sciences University ( Site 0804)
city: San Juan
country: Puerto Rico
facility: Gynecology & Endometriosis Center LLC ( Site 0806)
city: San Juan
country: Puerto Rico
facility: Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
city: San Juan
country: Puerto Rico
facility: Genes Fertility Institute Inc. ( Site 0803)
city: Kazan
country: Russian Federation
facility: Kazan State Medical University ( Site 0404)
city: Kazan
country: Russian Federation
facility: Clinical Hospital #2 of Kazan city ( Site 0406)
city: Kazan
country: Russian Federation
facility: LLC Scientific Research Medical Complex Your Health. ( Site 0405)
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
city: Moscow
country: Russian Federation
facility: State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
city: Saint Petersburg
country: Russian Federation
facility: NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
city: Smolensk
country: Russian Federation
facility: Uromed LLC ( Site 0410)
city: St. Petersburg
country: Russian Federation
facility: Women clinic 22 ( Site 0400)
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University ( Site 0402)
city: Aravaca
country: Spain
facility: Hospital Sanitas La Zarzuela ( Site 0502)
state: Madrid
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas.ICM ( Site 0500)
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona ( Site 0501)
city: Madrid
country: Spain
facility: Hospital Sanitas La Moraleja ( Site 0504)
city: Ivano-Frankivsk
country: Ukraine
facility: Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 0900)
city: Kyiv
country: Ukraine
facility: GI Institute of POG of NAMS of Ukraine ( Site 0905)
city: Kyiv
country: Ukraine
facility: City Clinical Hospital No. 9 ( Site 0901)
city: Odessa
country: Ukraine
facility: Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
city: Ternopil
country: Ukraine
facility: Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
city: Zaporizhzhya
country: Ukraine
facility: Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
city: Zaporizhzhya
country: Ukraine
facility: Communal Institution Maternity Hospital 3 ( Site 0909)
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.