Phase 2
N=187
A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)
Endometriosis-related Pain
Bottom Line
View on ClinicalTrials.gov: NCT03654326 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 — -2.2; -1.7 Scores on a Scale — p=0.066
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gefapixant (Drug); Placebo (Drug); Naproxen (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2 |
-2.2; -1.7 | 0.066 |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event |
53.2; 35.5 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event |
3.2; 0.0 | — |
| SECONDARY Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2 |
-2.0; -1.3 | — |
| SECONDARY Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2 |
-2.3; -1.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03654326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.