Last updated on March 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endometriosis Related Pain
  • Age: Between 18 - 49 Years
  • Gender: Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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