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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 (ELENA)

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OG-6219
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis Related Pain (ERP), Endometriosis, Pre-menopausal women

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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
  • 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 infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
  • Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy.
  • History of malignancy ≤5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia.
  • Has a medical condition associated with hemolytic anemia
  • Known human immunodeficiency virus infection, with active, recurrent, or chronic infection (eg, hepatitis A, B, or C virus)
  • Has a clinically significant abnormal ECG or QT interval prolongation
  • Used any medication that is either a sensitive substrate, moderate, or strong inhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing.

Sites / Locations

  • Paramount Research SolutionsRecruiting
  • The Advanced Gynecologic Surgery InstituteRecruiting
  • Clinical Trials Management, LLCRecruiting
  • Omni Fertility and Laser InstituteRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Unified Women's Clinical Research-Lyndhurst Clinical ResearchRecruiting
  • Centricity Research DublinRecruiting
  • Clinical Research of Philadelphia, LLCRecruiting
  • Chattanooga Medical Research, LLCRecruiting
  • Clinical Trial Network LLCRecruiting
  • Northeast Clinical Research of San AntonioRecruiting
  • Wasatch Clinical ResearchRecruiting
  • Tidewater Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

OG-6219 Dose 1

OG-6219 Dose 2

OG-6219 Dose 3

Placebo

Arm Description

OG-6219 Dose 1 BID

OG-6219 Dose 2 BID

OG-6219 Dose 3 BID

Outcomes

Primary Outcome Measures

Mean change from first treatment cycle to last planned treatment cycle of the daily OPP score.
The OPP measures endometriosis-related pain using NRS with range 0(no pain) to 10(worst imaginable).
Safety and tolerability of OG-6219
Safety and tolerability of the treatment is assessed by proportion of participants who experienced any AEs/SAEs, by abnormalities in clinical laboratory assessments, vital signs, and physical examination, and by proportion of participants who prematurely discontinued study treatment due to AEs/SAEs.

Secondary Outcome Measures

Mean change from first treatment cycle to last planned treatment cycle of the daily DYS score
Mean change from first treatment cycle to last planned treatment cycle of the daily NMPP score
Mean change from first treatment cycle to remaining treatment cycles in daily number of tablets of rescue medication for endometriosis-related pain.
Mean change from first treatment cycle to remaining treatment cycles in the proportion of days participant has used rescue medication for endometriosis-related pain.
Mean change from Visit 1 to Visit 7 in serum hormone levels.
Mean change at Visit 5 and Visit 7 in serum hormone levels.
Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling during the treatment period.
Mean change from Visit 1 to Visit 7 in bone biomarker levels
Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8.
Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding
ECG parameter changes at each of the four treatment cycle visits
Change from first treatment cycle to last planned treatment cycle in the Mean EHP-30 Domain Scores
Mean change in dyspareunia as measured by NRS from eDiary from first treatment cycle to last planned treatment cycle.
Change in PGI-S score from first treatment cycle to second, third and fourth treatment cycles.
Percent of participants with any improvement on the PGI-C from first treatment cycle to last planned treatment cycle.

Full Information

First Posted
September 20, 2022
Last Updated
December 9, 2022
Sponsor
Organon and Co
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05560646
Brief Title
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
Acronym
ELENA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up. Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened to randomly assign to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis Related Pain (ERP), Endometriosis, Pre-menopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OG-6219 Dose 1
Arm Type
Experimental
Arm Description
OG-6219 Dose 1 BID
Arm Title
OG-6219 Dose 2
Arm Type
Experimental
Arm Description
OG-6219 Dose 2 BID
Arm Title
OG-6219 Dose 3
Arm Type
Experimental
Arm Description
OG-6219 Dose 3 BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OG-6219
Intervention Description
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 during treatment cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
Primary Outcome Measure Information:
Title
Mean change from first treatment cycle to last planned treatment cycle of the daily OPP score.
Description
The OPP measures endometriosis-related pain using NRS with range 0(no pain) to 10(worst imaginable).
Time Frame
First treatment cycle to last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Safety and tolerability of OG-6219
Description
Safety and tolerability of the treatment is assessed by proportion of participants who experienced any AEs/SAEs, by abnormalities in clinical laboratory assessments, vital signs, and physical examination, and by proportion of participants who prematurely discontinued study treatment due to AEs/SAEs.
Time Frame
First treatment cycle through completion of follow-up, an average of 20 weeks (each cycle is approximately 28 days).
Secondary Outcome Measure Information:
Title
Mean change from first treatment cycle to last planned treatment cycle of the daily DYS score
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change from first treatment cycle to last planned treatment cycle of the daily NMPP score
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change from first treatment cycle to remaining treatment cycles in daily number of tablets of rescue medication for endometriosis-related pain.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change from first treatment cycle to remaining treatment cycles in the proportion of days participant has used rescue medication for endometriosis-related pain.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change from Visit 1 to Visit 7 in serum hormone levels.
Time Frame
Screening through end of treatment, an average of 24 weeks.
Title
Mean change at Visit 5 and Visit 7 in serum hormone levels.
Time Frame
Visit 5 through Visit 7, an average of 9 weeks.
Title
Plasma concentrations of OG-6219 and FOR-1011 at scheduled assessments using sparse PK sampling during the treatment period.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change from Visit 1 to Visit 7 in bone biomarker levels
Time Frame
Screening through end of treatment, an average of 24 weeks.
Title
Proportion of participants with clinical parameters of significance from Visit 1 to Visit 5, Visit 6, Visit 7, and Visit 8.
Time Frame
Screening through safety follow-up, an average of 28 weeks.
Title
Mean change from first treatment cycle to second, third and fourth treatment cycles in the percentage of days with vaginal bleeding
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
ECG parameter changes at each of the four treatment cycle visits
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Change from first treatment cycle to last planned treatment cycle in the Mean EHP-30 Domain Scores
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Mean change in dyspareunia as measured by NRS from eDiary from first treatment cycle to last planned treatment cycle.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Change in PGI-S score from first treatment cycle to second, third and fourth treatment cycles.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days).
Title
Percent of participants with any improvement on the PGI-C from first treatment cycle to last planned treatment cycle.
Time Frame
First treatment cycle through completion of last planned treatment cycle, an average of 16 weeks (each cycle is approximately 28 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 infection (STI) (eg, gonorrhea, chlamydia, or trichomonas). Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy. History of malignancy ≤5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia. Has a medical condition associated with hemolytic anemia Known human immunodeficiency virus infection, with active, recurrent, or chronic infection (eg, hepatitis A, B, or C virus) Has a clinically significant abnormal ECG or QT interval prolongation Used any medication that is either a sensitive substrate, moderate, or strong inhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
551-430-6000
Email
OG-6219-P001@IQVIA.com
Facility Information:
Facility Name
Paramount Research Solutions
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Adams
Phone
404-657-4500
Email
abadams.prs@gmail.com
First Name & Middle Initial & Last Name & Degree
Stacy Hooper
Phone
(404) 657-4500
Email
shooper@prsstudy.com
First Name & Middle Initial & Last Name & Degree
Anthony Adams
Facility Name
The Advanced Gynecologic Surgery Institute
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Miller
Phone
630-364-1119
Email
chuckmillermd@gmail.com
First Name & Middle Initial & Last Name & Degree
Mary Johnston
Phone
(630) 364-1112
Email
mjohnston@drcharlesmiller.com
First Name & Middle Initial & Last Name & Degree
Charles Miller
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Rodriguez
Phone
504-455-1310
Email
arodriguezmd@clinicaltrialsmgt.com
First Name & Middle Initial & Last Name & Degree
Rose Roche
Phone
(504) 455-1310
Email
rroche@clinicaltrialsmgt.com
First Name & Middle Initial & Last Name & Degree
Alison Rodriguez
Facility Name
Omni Fertility and Laser Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard Weather
Phone
318-671-5320
Email
dr_weather@bellsouth.net
First Name & Middle Initial & Last Name & Degree
Valerie Davis
Phone
(318) 671-5320
Email
dr_weather@bellsouth.net
First Name & Middle Initial & Last Name & Degree
Leonard Weather
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Vrbicky
Phone
402-371-0797
Email
kvrbicky@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Ashleigh Avecilla
Phone
(402) 371-0797
Email
aAvecilla@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Keith Vrbicky
Facility Name
Unified Women's Clinical Research-Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Parker
Phone
336-354-1076
Email
lamar.parker@unifiedhc.com
First Name & Middle Initial & Last Name & Degree
Nicole Cline
Phone
(866) 853-0220
Email
nicole.cline@unifiedhc.com
First Name & Middle Initial & Last Name & Degree
Robert Parker
Facility Name
Centricity Research Dublin
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Artman
Phone
614-501-6164
Email
sartman@aventivresearch.com
First Name & Middle Initial & Last Name & Degree
Rachel Flora
Phone
(614) 501-6164
Email
rflora@aventivresearch.com
First Name & Middle Initial & Last Name & Degree
Sarah Artman
Facility Name
Clinical Research of Philadelphia, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Andruczyk
Phone
215-676-6696
Email
eugene@phillyresearch.com
First Name & Middle Initial & Last Name & Degree
Lolita Vaughan
Phone
(215) 676-6696
Email
Lolita@phillyresearch.com
First Name & Middle Initial & Last Name & Degree
Eugene Andruczyk
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Barker
Phone
423-648-7794
Email
dbarker@obgyncentre.net
First Name & Middle Initial & Last Name & Degree
Jeana Ricks
Phone
(423) 648-7794
Email
jricks@chattmedresearch.com
First Name & Middle Initial & Last Name & Degree
David Barker
Facility Name
Clinical Trial Network LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangeetha Vulichi
Phone
713-484-6947
Email
svulichi@ctntexas.com
First Name & Middle Initial & Last Name & Degree
Diana Baron
Phone
(832) 614-2053
Email
dbaron@ctntexas.com
First Name & Middle Initial & Last Name & Degree
Sangeetha Vulichi
Facility Name
Northeast Clinical Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Garza
Phone
210-653-5501
Email
josephgarza.necrsa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Peter Carbajal
Phone
(210) 581-0045
Email
peter.carbajal@necrsa.com
First Name & Middle Initial & Last Name & Degree
Joseph Garza
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mara Rabin
Phone
801-288-0607
Email
mrabin@wasatchcrc.com
First Name & Middle Initial & Last Name & Degree
Emily Beck
Phone
(801) 288-0607
Email
ebeck@wasatchcrc.com
First Name & Middle Initial & Last Name & Degree
Mara Rabin
Facility Name
Tidewater Clinical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad-Mehdi Parva
Phone
757-471-3375
Email
mehdi.parva@tidewaterclinresearch.com
First Name & Middle Initial & Last Name & Degree
April Rusch
Phone
(757)471-3375
Email
april.rusch@tidewaterclinresearch.com
First Name & Middle Initial & Last Name & Degree
Mohamad-Mehdi Parva

12. IPD Sharing Statement

Learn more about this trial

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

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