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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7264-034 | Other Identifier | MSD Protocol Number | |
| 2018-001098-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant | Drug | Gefapixant tablet 45 mg taken orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
| 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. | Up to approximately 10 weeks |
| 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. | Up to approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Medical Care ( Site 0750) | Birmingham | Alabama | 35218 | United States | ||
| Synexus US Phoenix Southeast ( Site 0729) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260540 | Result | 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. |
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This study included a baseline menstrual cycle (approximately 4 weeks) prior to randomization to either gefapixant or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant | Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2018 |
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| Placebo | Drug | Placebo matching gefapixant tablet taken orally |
|
| Naproxen | Drug | Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator |
|
| Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
| 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. | Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Synexus ( Site 0734) | Scottsdale | Arizona | 85251 | United States |
| Lynn Institute of the Ozarks ( Site 0720) | Little Rock | Arkansas | 72205 | United States |
| California Center for Clinical Research ( Site 0741) | Arcadia | California | 91007 | United States |
| Artemis Institute for Clinical Research ( Site 0716) | San Diego | California | 92103 | United States |
| Alta California Medical Group ( Site 0721) | Simi Valley | California | 93065 | United States |
| Thameside OBGYN Center ( Site 0747) | Groton | Connecticut | 06340 | United States |
| WHUSA Fine and Gillette ( Site 0751) | Hamden | Connecticut | 06518 | United States |
| Florida Fertility Institute ( Site 0737) | Clearwater | Florida | 33759 | United States |
| Advanced Pharma Research ( Site 0719) | Cutler Bay | Florida | 33189 | United States |
| Doral Medical Research, LLC ( Site 0706) | Doral | Florida | 33166 | United States |
| KO Clinical Research, LLC ( Site 0723) | Fort Lauderdale | Florida | 33316 | United States |
| Well Pharma Medical Research, Corp. ( Site 0703) | Miami | Florida | 33143 | United States |
| L&C Professional Medical Research Institute ( Site 0709) | Miami | Florida | 33144 | United States |
| New Horizon Research Center ( Site 0717) | Miami | Florida | 33465 | United States |
| Inpatient Research Clinic, LLC ( Site 0725) | Miami Lakes | Florida | 33014 | United States |
| QPS Miami Research Associates ( Site 0735) | South Miami | Florida | 33143 | United States |
| Lenus Research & Medical Group Llc ( Site 0702) | Sweetwater | Florida | 33172 | United States |
| Southern Clinical Research Associates ( Site 0701) | Metairie | Louisiana | 70001 | United States |
| Tufts Medical Center ( Site 0742) | Boston | Massachusetts | 02111 | United States |
| Carolina Women's Research and Wellness Center ( Site 0715) | Durham | North Carolina | 27713 | United States |
| Palmetto Clinical Research ( Site 0707) | Summerville | South Carolina | 29485 | United States |
| Chattanooga Medical Research ( Site 0743) | Chattanooga | Tennessee | 37404 | United States |
| Women Partners in Health ( Site 0745) | Austin | Texas | 78705 | United States |
| Corpus Christi Clinic ( Site 0744) | Corpus Christi | Texas | 78412 | United States |
| HD Research Corp ( Site 0738) | Houston | Texas | 77024 | United States |
| PI-Coor Clinical Research, LLC ( Site 0710) | Reston | Virginia | 20190 | United States |
| Clinical Research Partners, LLC. ( Site 0704) | Richmond | Virginia | 23225 | United States |
| Seattle Women's: Health, Research, Gynecology ( Site 0714) | Seattle | Washington | 98105 | United States |
| Paratus Clinical Kanwal ( Site 0004) | Kanwal | New South Wales | 2259 | Australia |
| Royal Hospital for Women ( Site 0008) | Randwick | New South Wales | 2031 | Australia |
| Holdsworth House Medical Practice ( Site 0009) | Sydney | New South Wales | 2010 | Australia |
| Royal Adelaide Hospital ( Site 0007) | Adelaide | South Australia | 5000 | Australia |
| Keogh Institute for Medical Research ( Site 0002) | Nedlands | Western Australia | 6009 | Australia |
| Hospital San Juan de Dios de La Serena ( Site 0110) | La Serena | Coquimbo Region | 1710216 | Chile |
| Hospital San Borja Arriaran ( Site 0103) | Santiago | Santiago Metropolitan | 8360160 | Chile |
| Clinica Indisa [Santiago, Chile] ( Site 0101) | Santiago | 7520440 | Chile |
| Clinica Las Condes ( Site 0109) | Santiago | 7591047 | Chile |
| Clinica Alemana de Santiago ( Site 0107) | Santiago | 7650568 | Chile |
| Southern Clinical Trials - Waitemata ( Site 0200) | Auckland | 0626 | New Zealand |
| Southern Clinical Trials Ltd ( Site 0201) | Christchurch | 8013 | New Zealand |
| Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300) | Bialystok | 15-224 | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316) | Katowice | 40-301 | Poland |
| SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339) | Katowice | 40-717 | Poland |
| Clinical Medical Research Sp. z o.o. ( Site 0343) | Katowice | 40-750 | Poland |
| Osrodek Badan Klinicznych Gyncentrum ( Site 0330) | Katowice | 40-851 | Poland |
| LIFTMED ( Site 0325) | Rybnik | 44-200 | Poland |
| Examen Sp. z o.o. ( Site 0318) | Skorzewo | 60-185 | Poland |
| Clinical Best Solutions ( Site 0338) | Warsaw | 02-793 | Poland |
| Marek Elias Gabinety Ginekologiczne ( Site 0331) | Wroclaw | 50-547 | Poland |
| Cooperativa de Facultad Medica Sanacoop ( Site 0805) | Bayamón | 00961 | Puerto Rico |
| Ponce Health Sciences University ( Site 0804) | Ponce | 00717-2348 | Puerto Rico |
| Gynecology & Endometriosis Center LLC ( Site 0806) | San Juan | 00909 | Puerto Rico |
| Henry A. Rodriguez-Ginorio Private Practice ( Site 0800) | San Juan | 00917 | Puerto Rico |
| Genes Fertility Institute Inc. ( Site 0803) | San Juan | 00918 | Puerto Rico |
| Kazan State Medical University ( Site 0404) | Kazan' | 420029 | Russia |
| Clinical Hospital #2 of Kazan city ( Site 0406) | Kazan' | 420033 | Russia |
| LLC Scientific Research Medical Complex Your Health. ( Site 0405) | Kazan' | 420097 | Russia |
| Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411) | Moscow | 101000 | Russia |
| State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408) | Moscow | 115280 | Russia |
| Women clinic 22 ( Site 0400) | Saint Petersburg | 194354 | Russia |
| NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401) | Saint Petersburg | 199034 | Russia |
| Uromed LLC ( Site 0410) | Smolensk | 214031 | Russia |
| Siberian State Medical University ( Site 0402) | Tomsk | 634050 | Russia |
| Hospital Sanitas La Zarzuela ( Site 0502) | Aravaca | Madrid | 28023 | Spain |
| Instituto de Ciencias Medicas.ICM ( Site 0500) | Alicante | 03004 | Spain |
| Hospital Clinic i Provincial de Barcelona ( Site 0501) | Barcelona | 08036 | Spain |
| Hospital Sanitas La Moraleja ( Site 0504) | Madrid | 28050 | Spain |
| Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910) | Ivano-Frankivsk | 76018 | Ukraine |
| Medical Center Verum ( Site 0900) | Kyiv | 03040 | Ukraine |
| GI Institute of POG of NAMS of Ukraine ( Site 0905) | Kyiv | 03067 | Ukraine |
| City Clinical Hospital No. 9 ( Site 0901) | Kyiv | 04112 | Ukraine |
| Multiprofile medical center on the base of Odessa National Medical University ( Site 0908) | Odesa | 65023 | Ukraine |
| Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903) | Ternopil | 46400 | Ukraine |
| Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904) | Zaporizhzhya | 69065 | Ukraine |
| Communal Institution Maternity Hospital 3 ( Site 0909) | Zaporizhzhya | 69071 | Ukraine |
| Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906) | Zaporizhzhya | 69071 | Ukraine |
Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefapixant | Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. |
| BG001 | Placebo | Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Average Daily Pelvic Pain Score | Pelvic pain severity was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The average of the daily pelvic pain scores entered in participants' electronic diaries (eDiaries) was calculated for the baseline cycle (approximately 28 days). | Mean | Standard Deviation | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least one dose of double-blind study intervention and had at least one day of eDiary entries during the post-randomization treatment cycle. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
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| Primary | 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. | All randomized participants who received at least one dose of study intervention. | Posted | Number | Percentage of Participants | Up to approximately 10 weeks |
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| Primary | 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. | All randomized participants who received at least one dose of study intervention. | Posted | Number | Percentage of Participants | Up to approximately 8 weeks |
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| Secondary | 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. | All randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available cyclic pelvic pain score data. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
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| Secondary | 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. | All randomized participants who received at least one dose of double-blind study intervention, had at least one day of eDiary entry during the post-randomization treatment cycle, and had available non-cyclic pelvic pain score data. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days) |
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All-cause mortality: Up to approximately 24 weeks Serious adverse events and other adverse events: Up to approximately 12 weeks
All randomized participants who received at least one dose of study intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gefapixant | Participants received a gefapixant 45 mg tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. | 0 | 94 | 0 | 94 | 36 | 94 |
| EG001 | Placebo | Participants received a placebo matching gefapixant tablet twice a day for approximately 8 weeks (2 menstrual cycles). Naproxen sodium 275 mg tablets were also provided to participants, as needed, for endometriosis-related pain. | 0 | 93 | 0 | 93 | 12 | 93 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jun 15, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000597312 | Gefapixant |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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