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

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Naproxen

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.