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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 49
Updated:3/31/2019
Start Date:September 11, 2018
End Date:November 27, 2019
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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) during Treatment Cycle 2.


Inclusion Criteria:

- has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis.

- has cyclic AND non-cyclic, moderate to severe endometriosis-related pelvic 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.
We found this trial at
22
sites
Seattle, Washington
Phone: 206-522-3330
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7000 SW 62 Ave.
Miami, Florida 33143
305-284-8483
Phone: 305-665-4818
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Miami, FL
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Chandler, Arizona 85224
Phone: 480-775-1115
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Chandler, AZ
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Clearwater, Florida 33759
Phone: 727-724-9730
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Clearwater, FL
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Cutler Bay, Florida 33189
Phone: 786-234-3709
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Cutler Bay, FL
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Doral, Florida 33166
Phone: 305-400-9207
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Doral, FL
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Durham, North Carolina 27713
Phone: 919-251-9223
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Durham, NC
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Fort Lauderdale, Florida 33316
Phone: 954-703-8988
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Fort Lauderdale, FL
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Little Rock, Arkansas 72205
Phone: 501-975-2000
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Little Rock, AR
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Metairie, Louisiana 70001
Phone: 504-810-4414
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Metairie, LA
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Miami, Florida
Phone: 305-269-1616
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Miami, FL
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Miami, Florida 33175
Phone: 305-226-3933
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Miami, FL
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Miami Lakes, Florida 33014
Phone: 786-502-4303
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Miami Lakes, FL
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Reston, Virginia 20190
Phone: 703-426-0800
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Reston, VA
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Richmond, Virginia
Phone: 804-920-0819
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Richmond, VA
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San Diego, California 92123
Phone: 858-278-3647
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San Diego, CA
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Scottsdale, Arizona 85251
Phone: 480-946-4455
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Scottsdale, AZ
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Simi Valley, California 93065
Phone: 805-578-9600
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Simi Valley, CA
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6141 Sunset Drive
South Miami, Florida 33143
Phone: 305-598-3125
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South Miami, FL
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Summerville, South Carolina 29485
Phone: 843-851-7098
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Summerville, SC
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Sweetwater, Florida 33172
Phone: 305-592-4692
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Sweetwater, FL
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Sydney, New South Wales
Phone: +61293317228
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