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Endometriosis-related PainPhase 2NCT03654326

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

A Phase 2 study testing Gefapixant and Naproxen in people with Endometriosis-related Pain, run by Merck Sharp & Dohme LLC at 78 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis-related Pain
What is being tested?
Gefapixant and Naproxen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
78 sitesin 9 countries
Study dates
11 Sep 2018to 30 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

78 sites in 9 countries.

78 sites in 9 countries

United States30 sites

  • California Center for Clinical Research ( Site 0741)

    Arcadia, California, 91007

  • Women Partners in Health ( Site 0745)

    Austin, Texas, 78705

  • Cahaba Medical Care ( Site 0750)

    Birmingham, Alabama, 35218

  • Tufts Medical Center ( Site 0742)

    Boston, Massachusetts, 02111

  • Synexus US Phoenix Southeast ( Site 0729)

    Chandler, Arizona, 85224

  • Chattanooga Medical Research ( Site 0743)

    Chattanooga, Tennessee, 37404

  • Florida Fertility Institute ( Site 0737)

    Clearwater, Florida, 33759

  • Corpus Christi Clinic ( Site 0744)

    Corpus Christi, Texas, 78412

  • Advanced Pharma Research ( Site 0719)

    Cutler Bay, Florida, 33189

  • Doral Medical Research, LLC ( Site 0706)

    Doral, Florida, 33166

  • Carolina Women's Research and Wellness Center ( Site 0715)

    Durham, North Carolina, 27713

  • KO Clinical Research, LLC ( Site 0723)

    Fort Lauderdale, Florida, 33316

  • Thameside OBGYN Center ( Site 0747)

    Groton, Connecticut, 06340

  • WHUSA Fine and Gillette ( Site 0751)

    Hamden, Connecticut, 06518

  • HD Research Corp ( Site 0738)

    Houston, Texas, 77024

  • Lynn Institute of the Ozarks ( Site 0720)

    Little Rock, Arkansas, 72205

  • Southern Clinical Research Associates ( Site 0701)

    Metairie, Louisiana, 70001

  • Well Pharma Medical Research, Corp. ( Site 0703)

    Miami, Florida, 33143

  • L&C Professional Medical Research Institute ( Site 0709)

    Miami, Florida, 33144

  • New Horizon Research Center ( Site 0717)

    Miami, Florida, 33465

  • Inpatient Research Clinic, LLC ( Site 0725)

    Miami Lakes, Florida, 33014

  • PI-Coor Clinical Research, LLC ( Site 0710)

    Reston, Virginia, 20190

  • Clinical Research Partners, LLC. ( Site 0704)

    Richmond, Virginia, 23225

  • Artemis Institute for Clinical Research ( Site 0716)

    San Diego, California, 92103

  • Synexus ( Site 0734)

    Scottsdale, Arizona, 85251

  • Seattle Women's: Health, Research, Gynecology ( Site 0714)

    Seattle, Washington, 98105

  • Alta California Medical Group ( Site 0721)

    Simi Valley, California, 93065

  • QPS Miami Research Associates ( Site 0735)

    South Miami, Florida, 33143

  • Palmetto Clinical Research ( Site 0707)

    Summerville, South Carolina, 29485

  • Lenus Research & Medical Group Llc ( Site 0702)

    Sweetwater, Florida, 33172

Other trials in United States

Poland9 sites

  • Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)

    Bialystok, 15-224

  • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)

    Katowice, 40-301

  • SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)

    Katowice, 40-717

  • Clinical Medical Research Sp. z o.o. ( Site 0343)

    Katowice, 40-750

  • Osrodek Badan Klinicznych Gyncentrum ( Site 0330)

    Katowice, 40-851

  • LIFTMED ( Site 0325)

    Rybnik, 44-200

  • Examen Sp. z o.o. ( Site 0318)

    Skorzewo, 60-185

  • Clinical Best Solutions ( Site 0338)

    Warsaw, 02-793

  • Marek Elias Gabinety Ginekologiczne ( Site 0331)

    Wroclaw, 50-547

Other trials in Poland

Russia9 sites

  • Kazan State Medical University ( Site 0404)

    Kazan', 420029

  • Clinical Hospital #2 of Kazan city ( Site 0406)

    Kazan', 420033

  • LLC Scientific Research Medical Complex Your Health. ( Site 0405)

    Kazan', 420097

  • Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)

    Moscow, 101000

  • State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)

    Moscow, 115280

  • Women clinic 22 ( Site 0400)

    Saint Petersburg, 194354

  • NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)

    Saint Petersburg, 199034

  • Uromed LLC ( Site 0410)

    Smolensk, 214031

  • Siberian State Medical University ( Site 0402)

    Tomsk, 634050

Other trials in Russia

Ukraine9 sites

  • Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)

    Ivano-Frankivsk, 76018

  • Medical Center Verum ( Site 0900)

    Kyiv, 03040

  • GI Institute of POG of NAMS of Ukraine ( Site 0905)

    Kyiv, 03067

  • City Clinical Hospital No. 9 ( Site 0901)

    Kyiv, 04112

  • Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)

    Odesa, 65023

  • Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)

    Ternopil, 46400

  • Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)

    Zaporizhzhya, 69065

  • Communal Institution Maternity Hospital 3 ( Site 0909)

    Zaporizhzhya, 69071

  • Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)

    Zaporizhzhya, 69071

Other trials in Ukraine

Australia5 sites

  • Royal Adelaide Hospital ( Site 0007)

    Adelaide, South Australia, 5000

  • Paratus Clinical Kanwal ( Site 0004)

    Kanwal, New South Wales, 2259

  • Keogh Institute for Medical Research ( Site 0002)

    Nedlands, Western Australia, 6009

  • Royal Hospital for Women ( Site 0008)

    Randwick, New South Wales, 2031

  • Holdsworth House Medical Practice ( Site 0009)

    Sydney, New South Wales, 2010

Other trials in Australia

Chile5 sites

  • Hospital San Juan de Dios de La Serena ( Site 0110)

    La Serena, Coquimbo Region, 1710216

  • Hospital San Borja Arriaran ( Site 0103)

    Santiago, Santiago Metropolitan, 8360160

  • Clinica Indisa [Santiago, Chile] ( Site 0101)

    Santiago, 7520440

  • Clinica Las Condes ( Site 0109)

    Santiago, 7591047

  • Clinica Alemana de Santiago ( Site 0107)

    Santiago, 7650568

Other trials in Chile

Puerto Rico5 sites

  • Cooperativa de Facultad Medica Sanacoop ( Site 0805)

    Bayamón, 00961

  • Ponce Health Sciences University ( Site 0804)

    Ponce, 00717-2348

  • Gynecology & Endometriosis Center LLC ( Site 0806)

    San Juan, 00909

  • Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)

    San Juan, 00917

  • Genes Fertility Institute Inc. ( Site 0803)

    San Juan, 00918

Other trials in Puerto Rico

Spain4 sites

  • Instituto de Ciencias Medicas.ICM ( Site 0500)

    Alicante, 03004

  • Hospital Sanitas La Zarzuela ( Site 0502)

    Aravaca, Madrid, 28023

  • Hospital Clinic i Provincial de Barcelona ( Site 0501)

    Barcelona, 08036

  • Hospital Sanitas La Moraleja ( Site 0504)

    Madrid, 28050

Other trials in Spain

New Zealand2 sites

  • Southern Clinical Trials - Waitemata ( Site 0200)

    Auckland, 0626

  • Southern Clinical Trials Ltd ( Site 0201)

    Christchurch, 8013

Other trials in New Zealand

About this study

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

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.

Being tested
Gefapixant, Placebo, Naproxen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefapixantDrug

    Also called MK-7264

    Gefapixant tablet 45 mg taken orally

  • PlaceboDrug

    Placebo matching gefapixant tablet taken orally

  • NaproxenDrug

    Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator

Study groups in NCT03654326
Study groupRoleWhat they receive
GefapixantExperimentalParticipants 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.
Receives: Drug: Gefapixant; Drug: Placebo; Drug: Naproxen
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Naproxen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

    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.

    Measured: Up to approximately 10 weeks

  3. 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.

    Measured: Up to approximately 8 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

  2. 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.

    Measured: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start11 Sep 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03654326
Sponsor's protocol ID
7264-034
Other IDs
MK-7264-034, 2018-001098-26, 2018
Status last verified
Oct 2024
First submitted
17 Aug 2018
Last updated
4 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 39260540

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefapixant and Naproxen in people with Endometriosis-related Pain, run by Merck Sharp & Dohme LLC at 78 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Poland, Russia, Ukraine, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 (time frame: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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