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 |
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.
(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
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7000 SW 62 Ave.
Miami, Florida 33143
Miami, Florida 33143
305-284-8483
Phone: 305-665-4818
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