Moderate to severe Endometriosis-related pain (ERP) MedDRA version: 20.0 Level: LLT Classification code 10014788 Term: Endometriosis related pain System Organ Class: 100000004872
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant has been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 10 years of study entry as documented by medical records 2. Participant has cyclic (secondary dysmenorrhea) AND non-cyclic, moderate to severe endometriosis-related pelvic pain, as confirmed by an overall score of =5 at Visit 1 based on the participant’s last 2 menstrual cycles using an NRS (0 10 anchored with 0 [no pain] and 10 [extremely severe pain]) 3. Participant has had spontaneous, (ie, without hormonal therapy) regular, menstrual cycles with a cycle length between 24 to 38 days (inclusive) for the past 2 months before Visit 1. 4. Participant is a female 5. Participant is from 18 years to 49 years of age inclusive, at the time of signing the informed consent 6. Participant’s body mass index (BMI) is between 18 kg/m2 to 40 kg/m2 inclusive, at Visit 1 7. Participant is not pregnant, not breastfeeding, and the following condition applies: The participant agrees to follow the contraceptive guidance from the time of signing informed consent through the last day of the post-treatment cycle of the study (Visit 7) or for at least 14 days after the last dose of double blind study intervention if the participant discontinues study intervention 8. The participant (or legally acceptable representative, if applicable) provides written informed consent for the study. Participant must be willing and able to comply with all aspects of the protocol, including the use of the eDiary, to the satisfaction of the investigator/qualified designee before randomization. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research 9. Participant must agree to switch from her usual analgesic medication to only that which is permitted in the study (ie, naproxen sodium rescue medication provided by the Sponsor) At Visit 3: 10. Participant’s menstrual cycle before Visit 3 (SC) was 24 to 38 days (inclusive) as documented in the eDiary 11. Participant reports at least moderate pelvic pain during the SC as defined by average daily pelvic pain (cyclic and non-cyclic) score >5 12. Participant has demonstrated compliance with >75% of daily eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake, intake of pain relief medication other than naproxen sodium provided by Sponsor, and impact of pelvic pain) during the SC 13. Participant has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the investigator according to the local label, for control of ERP during the SC as evidenced in the eDiary At Visit 4: 14. Participant’s menstrual cycle before Visit 4 (BC) was 24 to 38 days (inclusive) as documented in the eDiary 15. Participant reports at least moderate pelvic pain during the BC as defined by average daily pelvic pain (cyclic and non-cyclic) score >5 16. Participant has demonstrated compliance with >75% of daily eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake, intake of pain relief medication other than naproxen sodium provided by Sponsor, and impact of pelvic pain) during the BC 17. Participant is =80% compliant with the placebo run-in medication (as determined by siteperformed tablet count) 18. Participant has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the investigator accord
Exclusion criteria
Exclusion criteria: 1. Participant had no pelvic pain for more than 50% of the days in her last menstrual cycle according to the participant’s recollection 2. Participant has a surgical history of hysterectomy and/or bilateral oophorectomy 3. Participant had undiagnosed (unexplained), abnormal, vaginal bleeding within the past 6 months before screening 4. Participant has chronic pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, pain caused by IC, BPS, adenomyosis [as confirmed by imaging], symptomatic uterine fibroids, irritable bowel syndrome, vulvodynia, or hysteroscopic sterilization) 5. Participant has chronic, non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, fibromyalgia, chronic back pain or chronic headaches) 6. Participant has a clinically significant gynecologic condition identified in the screening evaluation including, but not limited to, endometriomas of any size, persistent (present longer than 4 months) complex ovarian cysts larger than 3 cm, simple ovarian cysts larger than 5 cm, or an active sexually transmitted disease. Participants may be rescreened after completing treatment for infection or for simple ovarian cysts 7. Participant plans to schedule elective surgery during the study execution or had surgery in the past 6 months before screening that continues to require pain management 8. Participant has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs 9. Participant has a known allergy/sensitivity or contraindication to MK-7264 or its excipients 10. Participant 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 NSAIDs 11. Participant has an estimated glomerular filtration rate 160 mm Hg or diastolic blood pressure >90 mm Hg at Visit 1 13. Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence, per the investigator’s discretion. Participants are asked to follow a specified restrictions on alcohol use during the study 14. Participant has a history of ERP that was non-responsive to treatment with CHCs, GnRH antagonists, GnRH agonists, progestins, or aromatase inhibitors 15. Participant has a history of malignancy =5 years before signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 16. Participant has donated or lost =1 unit of blood (approximately 300 mL) within 8 weeks before the first dose of MK-7264 17. Participant has a positive urine pregnancy test at any time before randomization. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive 18. Participant has required more than 2 weeks of continuous use of narcotics for treatment of ERP within 6 months of Visit 1 19. Participant has received/must continue to receive any treatm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily pelvic pain (cyclic and non-cyclic, combined) during Treatment Cycle 2 (TRC2) as measured by a numeric rating scale (NRS) in the daily eDiary 2)To evaluate the safety and tolerability of MK- 7264;Secondary Objective: 1) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily cyclic pelvic pain during TRC2 as measured by an NRS in the daily eDiary 2) To evaluate the efficacy of MK-7264 versus placebo in reducing average daily non-cyclic pelvic pain during TRC2 as measured by an NRS in the daily eDiary;Primary end point(s): 1) Average daily pelvic pain scores (cyclic and non-cyclic) during Treatment Cycle 2 (TRC2) 2) The proportion of participants with adverse events (AEs) 3) The proportion of participants with an AE which leads to discontinuation;Timepoint(s) of evaluation of this end point: Treatment Cycle 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Average daily cyclic pelvic pain scores during TRC2 2) Average daily non-cyclic pelvic pain scores during TRC2;Timepoint(s) of evaluation of this end point: Treatment Cycle 2 | — |
Countries
Australia, Chile, New Zealand, Poland, Russian Federation, Spain, United States
Contacts
Public ContactInvestigación Clínica
Merck Sharp & Dohme de España S.A.
Outcome results
None listed