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

Primary Purpose

Endometriosis-related Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gefapixant
Placebo
Naproxen
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis-related Pain

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cahaba Medical Care ( Site 0750)
  • Synexus US Phoenix Southeast ( Site 0729)
  • Synexus ( Site 0734)
  • Lynn Institute of the Ozarks ( Site 0720)
  • California Center for Clinical Research ( Site 0741)
  • Artemis Institute for Clinical Research ( Site 0716)
  • Alta California Medical Group ( Site 0721)
  • Thameside OBGYN Center ( Site 0747)
  • WHUSA Fine and Gillette ( Site 0751)
  • Florida Fertility Institute ( Site 0737)
  • Advanced Pharma Research ( Site 0719)
  • Doral Medical Research, LLC ( Site 0706)
  • KO Clinical Research, LLC ( Site 0723)
  • Inpatient Research Clinic, LLC ( Site 0725)
  • Well Pharma Medical Research, Corp. ( Site 0703)
  • L&C Professional Medical Research Institute ( Site 0709)
  • New Horizon Research Center ( Site 0717)
  • QPS Miami Research Associates ( Site 0735)
  • Lenus Research & Medical Group Llc ( Site 0702)
  • Southern Clinical Research Associates ( Site 0701)
  • Tufts Medical Center ( Site 0742)
  • Carolina Women's Research and Wellness Center ( Site 0715)
  • Palmetto Clinical Research ( Site 0707)
  • Chattanooga Medical Research ( Site 0743)
  • Women Partners in Health ( Site 0745)
  • Corpus Christi Clinic ( Site 0744)
  • HD Research Corp ( Site 0738)
  • PI-Coor Clinical Research, LLC ( Site 0710)
  • Clinical Research Partners, LLC. ( Site 0704)
  • Seattle Women's: Health, Research, Gynecology ( Site 0714)
  • Paratus Clinical Kanwal ( Site 0004)
  • Royal Hospital for Women ( Site 0008)
  • Holdsworth House Medical Practice ( Site 0009)
  • Royal Adelaide Hospital ( Site 0007)
  • Keogh Institute for Medical Research ( Site 0002)
  • Hospital San Juan de Dios de La Serena ( Site 0110)
  • Hospital San Borja Arriaran ( Site 0103)
  • Clinica Indisa [Santiago, Chile] ( Site 0101)
  • Clinica Las Condes ( Site 0109)
  • Clinica Alemana de Santiago ( Site 0107)
  • Southern Clinical Trials - Waitemata ( Site 0200)
  • Southern Clinical Trials Ltd ( Site 0201)
  • Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
  • Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
  • SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)
  • Clinical Medical Research Sp. z o.o. ( Site 0343)
  • Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
  • LIFTMED ( Site 0325)
  • Examen Sp. z o.o. ( Site 0318)
  • Clinical Best Solutions ( Site 0338)
  • Marek Elias Gabinety Ginekologiczne ( Site 0331)
  • Cooperativa de Facultad Medica Sanacoop ( Site 0805)
  • Ponce Health Sciences University ( Site 0804)
  • Gynecology & Endometriosis Center LLC ( Site 0806)
  • Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
  • Genes Fertility Institute Inc. ( Site 0803)
  • Kazan State Medical University ( Site 0404)
  • Clinical Hospital #2 of Kazan city ( Site 0406)
  • LLC Scientific Research Medical Complex Your Health. ( Site 0405)
  • Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
  • State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
  • NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
  • Uromed LLC ( Site 0410)
  • Women clinic 22 ( Site 0400)
  • Siberian State Medical University ( Site 0402)
  • Hospital Sanitas La Zarzuela ( Site 0502)
  • Instituto de Ciencias Medicas.ICM ( Site 0500)
  • Hospital Clinic i Provincial de Barcelona ( Site 0501)
  • Hospital Sanitas La Moraleja ( Site 0504)
  • Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
  • Medical Center Verum ( Site 0900)
  • GI Institute of POG of NAMS of Ukraine ( Site 0905)
  • City Clinical Hospital No. 9 ( Site 0901)
  • Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
  • Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
  • Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
  • Communal Institution Maternity Hospital 3 ( Site 0909)
  • Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefapixant

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 17, 2018
Last Updated
June 15, 2021
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03654326
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis-related Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefapixant
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gefapixant
Other Intervention Name(s)
MK-7264
Intervention Description
Gefapixant tablet 45 mg taken orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching gefapixant tablet taken orally
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
Primary Outcome Measure Information:
Title
Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
Description
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.
Time Frame
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Title
Percentage of Participants Who Experienced an Adverse Event
Description
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.
Time Frame
Up to approximately 10 weeks
Title
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Description
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.
Time Frame
Up to approximately 8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
Description
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.
Time Frame
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)
Title
Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
Description
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.
Time Frame
Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Medical Care ( Site 0750)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35218
Country
United States
Facility Name
Synexus US Phoenix Southeast ( Site 0729)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synexus ( Site 0734)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Lynn Institute of the Ozarks ( Site 0720)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
California Center for Clinical Research ( Site 0741)
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Artemis Institute for Clinical Research ( Site 0716)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Alta California Medical Group ( Site 0721)
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Thameside OBGYN Center ( Site 0747)
City
Groton
State/Province
Connecticut
ZIP/Postal Code
06340
Country
United States
Facility Name
WHUSA Fine and Gillette ( Site 0751)
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Florida Fertility Institute ( Site 0737)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Advanced Pharma Research ( Site 0719)
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Doral Medical Research, LLC ( Site 0706)
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
KO Clinical Research, LLC ( Site 0723)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Inpatient Research Clinic, LLC ( Site 0725)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Well Pharma Medical Research, Corp. ( Site 0703)
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
L&C Professional Medical Research Institute ( Site 0709)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
New Horizon Research Center ( Site 0717)
City
Miami
State/Province
Florida
ZIP/Postal Code
33465
Country
United States
Facility Name
QPS Miami Research Associates ( Site 0735)
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Lenus Research & Medical Group Llc ( Site 0702)
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Southern Clinical Research Associates ( Site 0701)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Tufts Medical Center ( Site 0742)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Carolina Women's Research and Wellness Center ( Site 0715)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Palmetto Clinical Research ( Site 0707)
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Chattanooga Medical Research ( Site 0743)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Women Partners in Health ( Site 0745)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Corpus Christi Clinic ( Site 0744)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
HD Research Corp ( Site 0738)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
PI-Coor Clinical Research, LLC ( Site 0710)
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
Clinical Research Partners, LLC. ( Site 0704)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Seattle Women's: Health, Research, Gynecology ( Site 0714)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Paratus Clinical Kanwal ( Site 0004)
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Royal Hospital for Women ( Site 0008)
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Holdsworth House Medical Practice ( Site 0009)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 0007)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Keogh Institute for Medical Research ( Site 0002)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Hospital San Juan de Dios de La Serena ( Site 0110)
City
La Serena
State/Province
Region De Coquimbo
ZIP/Postal Code
1710216
Country
Chile
Facility Name
Hospital San Borja Arriaran ( Site 0103)
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8360160
Country
Chile
Facility Name
Clinica Indisa [Santiago, Chile] ( Site 0101)
City
Santiago
ZIP/Postal Code
7520440
Country
Chile
Facility Name
Clinica Las Condes ( Site 0109)
City
Santiago
ZIP/Postal Code
7591047
Country
Chile
Facility Name
Clinica Alemana de Santiago ( Site 0107)
City
Santiago
ZIP/Postal Code
7650568
Country
Chile
Facility Name
Southern Clinical Trials - Waitemata ( Site 0200)
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd ( Site 0201)
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Prywatna Klinika Polozniczo - Ginekologiczna ( Site 0300)
City
Bialystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk ( Site 0316)
City
Katowice
ZIP/Postal Code
40-301
Country
Poland
Facility Name
SPL Chorob Kobiecych i Połoznictwa dr L. Kobielska ( Site 0339)
City
Katowice
ZIP/Postal Code
40-717
Country
Poland
Facility Name
Clinical Medical Research Sp. z o.o. ( Site 0343)
City
Katowice
ZIP/Postal Code
40-750
Country
Poland
Facility Name
Osrodek Badan Klinicznych Gyncentrum ( Site 0330)
City
Katowice
ZIP/Postal Code
40-851
Country
Poland
Facility Name
LIFTMED ( Site 0325)
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Examen Sp. z o.o. ( Site 0318)
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Clinical Best Solutions ( Site 0338)
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Marek Elias Gabinety Ginekologiczne ( Site 0331)
City
Wroclaw
ZIP/Postal Code
50-547
Country
Poland
Facility Name
Cooperativa de Facultad Medica Sanacoop ( Site 0805)
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Ponce Health Sciences University ( Site 0804)
City
Ponce
ZIP/Postal Code
00717-2348
Country
Puerto Rico
Facility Name
Gynecology & Endometriosis Center LLC ( Site 0806)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Henry A. Rodriguez-Ginorio Private Practice ( Site 0800)
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Genes Fertility Institute Inc. ( Site 0803)
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Kazan State Medical University ( Site 0404)
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Clinical Hospital #2 of Kazan city ( Site 0406)
City
Kazan
ZIP/Postal Code
420033
Country
Russian Federation
Facility Name
LLC Scientific Research Medical Complex Your Health. ( Site 0405)
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Moscow Regional Research Institute of Tocology and Gynecolog ( Site 0411)
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
State Institution of Healthcare Moscow City Clinical Hospital 13 ( Site 0408)
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
NII of Obstetrics, Gynecology and Reproductology n.a. D.O. Ott ( Site 0401)
City
Saint Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Uromed LLC ( Site 0410)
City
Smolensk
ZIP/Postal Code
214031
Country
Russian Federation
Facility Name
Women clinic 22 ( Site 0400)
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Siberian State Medical University ( Site 0402)
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Hospital Sanitas La Zarzuela ( Site 0502)
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Instituto de Ciencias Medicas.ICM ( Site 0500)
City
Alicante
ZIP/Postal Code
03004
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona ( Site 0501)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Sanitas La Moraleja ( Site 0504)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Iv-Fr Reg Perinatal center State higher Educa inst Iv-Fr Nat Med University ( Site 0910)
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Medical Center Verum ( Site 0900)
City
Kyiv
ZIP/Postal Code
03040
Country
Ukraine
Facility Name
GI Institute of POG of NAMS of Ukraine ( Site 0905)
City
Kyiv
ZIP/Postal Code
03067
Country
Ukraine
Facility Name
City Clinical Hospital No. 9 ( Site 0901)
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Multiprofile medical center on the base of Odessa National Medical University ( Site 0908)
City
Odessa
ZIP/Postal Code
65023
Country
Ukraine
Facility Name
Communal not commercial institution. Ternopil City Community Hospital 2 ( Site 0903)
City
Ternopil
ZIP/Postal Code
46400
Country
Ukraine
Facility Name
Communal Nonprofit Enterprize Maternity Hospital 4 ( Site 0904)
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Communal Institution Maternity Hospital 3 ( Site 0909)
City
Zaporizhzhya
ZIP/Postal Code
69071
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhya Regional Clinical Hospital ( Site 0906)
City
Zaporizhzhya
ZIP/Postal Code
69071
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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