A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo … (NCT05560646) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
United States, Belgium, Bulgaria354 participantsStarted 2022-10-25
Plain-language summary
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
* Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
* Moderate to severe endometriosis-related pelvic pain
* Regular menstrual cycles
* Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
* Normal breast exam at V1. In participants of ≥40 years mammography or contrast-enhanced breast MRI performed within the last 12 months prior to Screening (V1) without clinically significant abnormal findings.
* Agree not to participate in another interventional study while participating in the present study.
* Able and willing to adhere to study procedures, including
* agree to use 2 forms of non-hormonal contraception throughout the study
* Must be willing and able to provide signed informed consent before any study-related activities
* Has demonstrated compliance with ≥75% of eDiary entries
* Has a negative pregnancy test
Exclusion Criteria:
* Surgical history of hysterectomy and/or bilateral oophorectomy
* Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
* Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
* Presence of high-risk human papillomavirus (HPV).
* Has an active sexually transmitted in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Timeframe: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
2
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
3
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Timeframe: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days