A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain - OG-6219-P001

Organon LLC0 sites364 target enrollmentSeptember 23, 2022

ConditionsEndometriosis related pain MedDRA version: 21.1Level: LLTClassification code: 10014788Term: Endometriosis related pain Class: 10038604 Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Endometriosis related pain
Sponsor: Organon LLC
Enrollment: 364
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Organon LLC

Eligibility Criteria

Inclusion Criteria

•Pre\-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1\)., At Visit 4: Has moderate to severe ERP, determined by the NRS (0 to 10 anchored, with 0 \[no pain] and 10 \[extremely severe pain]), at V4 (before Randomization), based on the eDiary entries from the participant’s last menstrual cycle (BC), as follows: a) An OPP (DYS and NMPP) score of \=4, OR b) For DYS at least 2 days with \=4 and NMPP score of \=4 on at least 7 days (not necessarily consecutive), OR c) For DYS at least 2 days with \=4 and NMPP score of \=7 on at least 3 days (not necessarily consecutive)., At Visit 4: Has demonstrated compliance with \=75% of eDiary entries (ie, pelvic pain score, vaginal bleeding, rescue medication intake) during both the screening cycle (SC) and the BC., At Visit 4: Is \=80% compliant with the Placebo tablets over the BC (Placebo Run\-in), as determined by tablet accountability at the site., At Visit 4: Has taken only the study provided rescue medication, at a dose not exceeding the maximum dose determined by the Investigator, for control of ERP during the BC as evidenced in the eDiary., Have a negative pregnancy test as outlined in the Schedule of activity of the protocol, Surgically (laparoscopy or laparotomy) diagnosed with endometriosis within the last 4 months to 10 years prior to Screening Visit (V1\), as documented by medical records, Has moderate to severe endometriosis\-related pelvic pain in recent menstrual cycle(s) using a cutoff score of \=4 in a numeric rating scale (NRS) and likely meets eligibility criterion \# 10 at Randomization Visit (V4\), Has had spontaneous (ie, without hormonal therapy), regular, menstrual cycle with a cycle length between 21 to 32 days (inclusive) for the past 1 month before V1, Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation., Has a normal breast examination at V1\. In participants of \=40 years mammography or contrast\-enhanced breast magnetic resonance imaging (MRI) performed within the last 12 months prior to Screening (V1\) without clinically significant abnormal findings., Agrees not to participate in another interventional study while participating in the present study., Is able and willing (in the opinion of the Investigator) to adhere to all required study procedures, including: a) Study visits schedule, b) Agree to switch from their usual analgesic to ONLY the rescue medication provided by the study and agree to discontinue their hormone treatment for ERP as outlined in Table 2 of the protocol. c) Agree to timely and duly complete eDiary entries, d) To cooperate and comply with the protocol requirements, including, Transvaginal ultrasound (TVUS), ECG, PK, and pharmacodynamic (PD) assessment among others. e) Agree to use 2 forms of non\-hormonal contraception throughout the study (from V1 thorough V8\). f) Not planning to relocate during the study (such that the participant would not be able to continue participation at the study site)., Must be willing and able to provide signed informed consent before any study\-related activities.

Exclusion Criteria

•Has a surgical history of hysterectomy and/or bilateral oophorectomy., Has a history or family history of a hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia (with an alteration in skin; color, pale, gray, or blue), or after receiving certain common drugs (ie, benzocaine, lidocaine, sulfonamides)., Has a medical condition associated with hemolytic anemia such as sickle cell anemia, thalassemia, glucose\-6\-phosphate dehydrogenase deficiency, thrombotic thrombocytopenic purpura among other conditions previously diagnosed and confirmed., Has an allergy/sensitivity/intolerance to rescue medication provided by Sponsor or any contraindication to its use and in the setting of coronary artery bypass grafting surgery, or has experienced asthma, urticaria, or allergic\-type reactions after taking aspirin or other Nonsteroidal anti\-inflammatory drug (NSAIDs), Has a history or current evidence of any unstable medical condition (including cardiovascular, bone, musculoskeletal, thyroid, diabetes), or other circumstance that in the opinion of the Investigator might confound the results of the study, affect participant’s safety or well\-being, or interfere with the participant’s participation for the full duration of the study, Has a known human immunodeficiency virus infection, and/or an acute or active, recurrent/relapsing or chronic infection (eg, hepatitis A, B, or C virus), Has a gastrointestinal, liver, kidney, or other disorder that would significantly interfere with the absorption, distribution, metabolism, or excretion of drugs in the opinion of the Investigator, Has a clinically significant abnormal ECG or QT interval prolongation at Screening Visit (V1\) or Randomization Visit (V4\). Any participant with the following conditions must be excluded: a)A marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>450 milliseconds) b)A history of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of Long QT Syndrome) c)Use of concomitant medications that prolong the QT/QTc interval (such as but not limited to: ibutilide, quinidine, imipramine, erythromycin, and droperidol)., Plans to schedule elective surgery during the study execution or had surgery in the past 4 months before screening that continues to require pain management., Suspected active Coronavirus Disease 2019 (COVID\-19\) infection a) Have tested positive for severe acute respiratory syndrome–related coronavirus 2 (SARS\-CoV\-2\) based on a validated test per local guidelines at Screening and Baseline b) Have to comply with quarantine requirements per local Public Health directive, Has been vaccinated with live or live\-attenuated virus vaccine within 30 days prior to Screening, Has chronic pelvic and/or non\-pelvic pain NOT CAUSED by endometriosis that requires chronic analgesic or other chronic therapy (including, but not limited to, pain caused by interstitial cystitis, bladder pain syndrome, irritable bowel syndrome, hysteroscopic sterilization, adenomyosis \[as confirmed by previous MRI], vaginismus, chronic pelvic infection, fibromyalgia, chronic headaches, chronic back pain). Participants using or who will be using frequent opioid analgesics, cannabis, or non\-opioids analgesics for chronic pain or recurring pain other than that due to ERP should also be excluded., Has an uncontrolled hypertension as diagnosed by participant’s treating physician., Has any of the follow