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TerminatedNCT05264506Updated Nov 21, 2025Results posted

Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

A Phase 3 interventional study of NOMAC-E2 COC in Contraception, sponsored by Organon and Co. Terminated at 103 sites in United States. Open to female participants aged 14 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Organon and Co · Phase 3, Interventional, and Prevention

Why this study was terminated
Sponsor decision to stop the study early and complete all required study close-out activities. This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed.
Phase
Phase 3
Study type
Interventional
Enrollment
3,055
Allocation
Not applicable
Ages
14 Years to 35 Years
Sex
Female
01

Study summary

The purpose of this study is evaluating Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive in Premenopausal Females Aged 14 to 35 Years (Inclusive).

Read the detailed description

This is a Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive). Potential participants must be sexually active and engage in heterosexual vaginal intercourse at least once per month with a partner who is not known to be subfertile, sterilized, or infertile, and should not routinely use any other form of contraception.

A total of 2,680 fertile premenopausal women aged 14 to 35 years (inclusive) will be screened to achieve about 1,878 (with at least 657 participants with BMI ≥30 kg/m2) being allocated to study treatment. Over 1,000 total participants are expected to complete 1 year of treatment (13 cycles).

The total duration of study participation will be up to 60 weeks, which includes a Pre-treatment Period of approximately 6 weeks, a Treatment Period of 52 weeks, and a Follow-up Period of 2 weeks after the last intake of study drug.

02

Conditions studied

  • Contraception

Keywords

  • Birth control methods
  • Contraceptive
  • Postmenarcheal Premenopausal Women
  • Hormonal
  • Sexually Active
03

In context

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive)
  • At risk for pregnancy (including heterosexual vaginal intercourse at least once a month and not sterilized).
  • No desire for pregnancy within 1 year following screening and is not intending to use any other form of contraception
  • Good physical and mental health
  • History of regular menstrual cycles prior to the use of any hormonal contraceptive.
  • Able and willing to adhere study procedures

Exclusion criteria

Exclusion Criteria:

  • Current known or expected pregnancy
  • History of subfertility or infertility
  • Less than 2 normal menstrual cycles following recent pregnancy of gestational age
  • Breastfeeding within 2 months of study drug start
  • Known HIV infection
  • Untreated gonorrhea, chlamydia, or trichomonas
  • abnormal PAP within timeline of standard of care guidelines
  • Unexplained/unresolved abnormal vaginal bleeding
  • Presence/history of VTE, ATE, transient ischemic attack, angina pectoris, or claudication
  • Higher risk for VTE
  • Uncontrolled or severe hypertension
  • Severe dyslipoproteinemia
  • History of migraine with aura or focal neurological symptoms
  • Diabetes mellitus (with either end-organ involvement or >20 years duration)
  • Multiple cardiovascular risk factors
  • History of pancreatitis associated with severe hypertriglyceridemia
  • Presence/history of clinically significant liver disease
  • History of malabsorptive surgical procedures
  • History of malignancy in last 5 years
  • Presence/history of meningioma
  • Disease that may worsen under hormonal treatment
  • Presence/history of severe depression (unless currently stable and asymptomatic)
  • Known allergy/sensitivity to NOMAC-E2
  • Drug or alcohol abuse/dependence in last 2 years
  • Clinically relevant abnormal lab result at screening
  • Expected use of other contraceptive medications or medications that induce liver enzymes during study
  • Used another investigational drug within 2 months of study drug start
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,055 participants (actual)

Study arms

  • Experimental
    Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)

    The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.

    Drug: NOMAC-E2 COC

Interventions

  • DrugNOMAC-E2 COC

    Dosage Formulation: Film-coated Tablet Unit Dose Strength: Nomegestrol acetate (NOMAC) 2.5 mg and estradiol (E2) 1.5 mg; Each blister strip contains 28 tablets: 24 tablets with the active drug (number 1 to 24) and 4 tablets with placebo (number 25 to 28). Dosing Instructions: oral. Take 1 tablet daily at about the same time as directed.

    Also known as: Nomegestrol acetate / estradiol

06

What researchers measure

Primary outcomes

  1. Number of Participants With On-treatment Pregnancies

    Raw count of the number of pregnancies that occurred while participants were taking study drug

    Time frame: 1 year

Secondary outcomes

  1. Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)

    Time frame: 1 year

  2. Proportion of Participants Who Prematurely Discontinue Study Drug Treatment

    Time frame: 1 year

  3. Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle

    Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle

    Time frame: 1 year

  4. Number of Cycles of Exposure Prior to Pregnancy

    In participants who experienced on-treatment pregnancy, the mean number of completed treatment cycles prior to occurrence of the pregnancy (for participants with known date of conception)

    Time frame: 1 year

  5. Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)

    Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category

    Time frame: 1 year

  6. Proportion of Participants With Bleeding-spotting Days

    Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle

    Time frame: 28-day cycles across one year

  7. Mean Number of Bleeding and/or Spotting Days Per Cycle

    For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle

    Time frame: 28-day cycles across one year

  8. Average Number of Bleeding-spotting Days Per Reference Period

    For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period

    Time frame: 91-day reference periods across one year

  9. Proportion of Participants With 8 or More Bleeding-spotting Days

    Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle

    Time frame: 28-day cycles across one year

  10. Mean NOMAC Concentration, Visit 3 Pre-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Time frame: Treatment Week 5

  11. Mean NOMAC Concentration, Visit 3 Post-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Time frame: Treatment Week 5

  12. Mean NOMAC Concentration, Visit 4 Pre-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Time frame: Treatment Week 17

  13. Mean NOMAC Concentration, Visit 4 Post-Dose

    NOMAC concentrations assessed through use of sparse sampling

    Time frame: Treatment Week 17

07

Results

Posted Nov 21, 2025
Limitations and caveats
Due to the study's early discontinuation (for business reasons), a small number of participants completed the study prior to its discontinuation, limiting the data available for efficacy outcome measures.

Participant flow

Participant flow — Overall Study
MilestoneNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Started1919
Completed402
Not completed1517
Withdrew: Adverse event59
Withdrew: Lost to follow-up204
Withdrew: Protocol violation185
Withdrew: Pregnancy60
Withdrew: Physician decision6
Withdrew: Non-compliance with study drug29
Withdrew: Study termination677
Withdrew: Withdrawal by subject208
Withdrew: Discontinued prior treatment89

Outcome measures

PrimaryNumber of Participants With On-treatment Pregnancies

Raw count of the number of pregnancies that occurred while participants were taking study drug

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With On-treatment Pregnancies
ParticipantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Number of Participants With On-treatment Pregnancies57
SecondaryProportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
Time frame:
1 year
Reported as:
Number · participants
Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
participantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)485
SecondaryProportion of Participants Who Prematurely Discontinue Study Drug Treatment
Time frame:
1 year
Reported as:
Number · participants
Proportion of Participants Who Prematurely Discontinue Study Drug Treatment
participantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Proportion of Participants Who Prematurely Discontinue Study Drug Treatment62
SecondaryPercentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle

Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle

Time frame:
1 year
Reported as:
Number · percentage of participants
Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle
percentage of participantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle3.1
SecondaryNumber of Cycles of Exposure Prior to Pregnancy

In participants who experienced on-treatment pregnancy, the mean number of completed treatment cycles prior to occurrence of the pregnancy (for participants with known date of conception)

Time frame:
1 year
Reported as:
Mean · completed cycles
Number of Cycles of Exposure Prior to Pregnancy
completed cyclesNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Number of Cycles of Exposure Prior to Pregnancy4.2 ± 3.47
SecondaryNumber of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)

Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
ParticipantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
BMI <30 kg/m239
BMI >=30 kg/m218
SecondaryProportion of Participants With Bleeding-spotting Days

Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle

Time frame:
28-day cycles across one year
Reported as:
Number · participants
Proportion of Participants With Bleeding-spotting Days
participantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Proportion of Participants With Bleeding-spotting Days1721
SecondaryMean Number of Bleeding and/or Spotting Days Per Cycle

For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle

Time frame:
28-day cycles across one year
Reported as:
Mean · bleeding-spotting days
Mean Number of Bleeding and/or Spotting Days Per Cycle
bleeding-spotting daysNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean Number of Bleeding and/or Spotting Days Per Cycle4.0 ± 3.44
SecondaryAverage Number of Bleeding-spotting Days Per Reference Period

For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period

Time frame:
91-day reference periods across one year
Reported as:
Mean · bleeding-spotting days
Average Number of Bleeding-spotting Days Per Reference Period
bleeding-spotting daysNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Average Number of Bleeding-spotting Days Per Reference Period13.1 ± 8.54
SecondaryProportion of Participants With 8 or More Bleeding-spotting Days

Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle

Time frame:
28-day cycles across one year
Reported as:
Number · participants
Proportion of Participants With 8 or More Bleeding-spotting Days
participantsNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Proportion of Participants With 8 or More Bleeding-spotting Days709
SecondaryMean NOMAC Concentration, Visit 3 Pre-Dose

NOMAC concentrations assessed through use of sparse sampling

Time frame:
Treatment Week 5
Reported as:
Mean · ng/mL
Mean NOMAC Concentration, Visit 3 Pre-Dose
ng/mLNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean NOMAC Concentration, Visit 3 Pre-Dose32.26 ± 310.457
SecondaryMean NOMAC Concentration, Visit 3 Post-Dose

NOMAC concentrations assessed through use of sparse sampling

Time frame:
Treatment Week 5
Reported as:
Mean · ng/mL
Mean NOMAC Concentration, Visit 3 Post-Dose
ng/mLNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean NOMAC Concentration, Visit 3 Post-Dose73.61 ± 742.410
SecondaryMean NOMAC Concentration, Visit 4 Pre-Dose

NOMAC concentrations assessed through use of sparse sampling

Time frame:
Treatment Week 17
Reported as:
Mean · ng/mL
Mean NOMAC Concentration, Visit 4 Pre-Dose
ng/mLNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean NOMAC Concentration, Visit 4 Pre-Dose36.01 ± 229.607
SecondaryMean NOMAC Concentration, Visit 4 Post-Dose

NOMAC concentrations assessed through use of sparse sampling

Time frame:
Treatment Week 17
Reported as:
Mean · ng/mL
Mean NOMAC Concentration, Visit 4 Post-Dose
ng/mLNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean NOMAC Concentration, Visit 4 Post-Dose58.01 ± 363.400

Adverse events

Collected over All AEs and SAEs were collected from the time of screening through the end of study/end of treatment visit, which was 14 to 19 days after the last intake of study drug, up to approximately 1 year, 1 month.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)0/1,830 (0%)10/1,830 (0.5%)0/1,830 (0%)
Most frequent serious events
Most frequent serious events
EventNomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Abortion spontaneousPregnancy, puerperium and perinatal conditions3/1830
Suicidal ideationPsychiatric disorders2/1830
Burns third degreeInjury, poisoning and procedural complications1/1830
Ligament ruptureInjury, poisoning and procedural complications1/1830
HeadacheNervous system disorders1/1830
ParaesthesiaNervous system disorders1/1830
Bipolar disorderPsychiatric disorders1/1830
Ovarian cyst rupturedReproductive system and breast disorders1/1830
Deep Vein ThrombosisVascular disorders1/1830
HypertensionVascular disorders1/1830

Baseline characteristics

The Safety Analysis Set consists of all participants who took at least one dose of the study treatment.

Age, Continuous
Age, Continuous(years)Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Mean27.2 ± 4.99
Sex: Female, Male
Sex: Female, Male(Participants)Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Female1830
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Hispanic or Latino1004
Not Hispanic or Latino817
Unknown or Not Reported9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
American Indian or Alaska Native15
Asian29
Native Hawaiian or Other Pacific Islander6
Black or African American356
White1358
More than one race34
Unknown or Not Reported32
Region of Enrollment
Region of Enrollment(Participants)Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
United States1830
08

Study locations

103 sites
  • Alabama Clinical Therapeutics, LLC
    Birmingham, Alabama 35235, United States
  • SEC Clinical Research
    Dothan, Alabama 36305, United States
  • Alliance for Multispecialty Research, LLC
    Mobile, Alabama 36608, United States
  • Velocity Clinical Research
    Mobile, Alabama 36608, United States
  • Mesa Obstetricians and Gynecologists
    Mesa, Arizona 85206, United States
  • Desert Clinical Research, LLC/CCT Research
    Mesa, Arizona 85213, United States
  • Velocity Clinical Research - Phoenix
    Phoenix, Arizona 85006, United States
  • Precision Trials AZ, LLC
    Phoenix, Arizona 85032, United States
  • Alliance for Multispecialty Research
    Tempe, Arizona 85281, United States
  • Noble Clinical Research
    Tucson, Arizona 85704, United States
  • Eclipse Clinical Research
    Tucson, Arizona 85745, United States
  • Gardens Medical Center / Alliance Research Institute
    Bell Gardens, California 90201, United States
  • Alliance Research Institute, LLC
    Canoga Park, California 91304, United States
  • Advanced Investigative Medicine, Inc
    Hawthorne, California 90250, United States
  • Marvel Clinical Research
    Huntington Beach, California 92647, United States
  • Om Research LLC
    Lancaster, California 93534, United States
  • Empire Clinical Research
    Pomona, California 91767, United States
  • WR-Women's Health Care Research, LLC
    San Diego, California 92111, United States
  • WR-Medical Center For Clinical Research - San Diego
    San Diego, California 92120, United States
  • Velocity Clinical Research
    Denver, Colorado 80209, United States
  • Physicians' Research Options / Red Rocks OB/GYN
    Lakewood, Colorado 80228, United States
  • CMR of Greater New Haven, LLC
    Hamden, Connecticut 06517, United States
  • Alliance for Multispecialty Research, LLC
    Coral Gables, Florida 33134, United States
  • Universal Axon Clinical Research, LLC
    Doral, Florida 33166, United States
  • Alliance for Multispecialty Research, LLC
    Fort Myers, Florida 33912, United States
  • Altus Research, Inc.
    Lake Worth, Florida 33461, United States
  • Accel Research Sites - St. Petersburg Clinical Research Unit
    Largo, Florida 33777, United States
  • OB-GYN Associates of Mid-Florida, PA
    Leesburg, Florida 34748, United States
  • Avantis Clinical Research, LLC
    Miami, Florida 33155, United States
  • Miami Clinical Research
    Miami, Florida 33155, United States
  • Admed Research, LLC
    Miami, Florida 33173, United States
  • Genoma Research Group, Inc.
    Miami, Florida 33173, United States
  • Spotlight Research Center, LLC
    Miami, Florida 33176, United States
  • New Age Medical Research Corporation
    Miami, Florida 33186, United States
  • Quantum Clinical Trials
    Miami Beach, Florida 33140, United States
  • Quality Research of South Florida
    Miami Lakes, Florida 33016, United States
  • Healthcare Clinical Data, Inc.
    North Miami, Florida 33161, United States
  • Sensible Healthcare LLC
    Ocoee, Florida 34761, United States
  • Innovation Medical Research Center
    Palmetto Bay, Florida 33157, United States
  • Clinical Research Center of Florida
    Pompano Beach, Florida 33060, United States
  • R & B Medical Center LLC
    Tampa, Florida 33614, United States
  • Comprehensive Clinical Research, LLC
    West Palm Beach, Florida 33409, United States
  • Agile Clinical Research Trials, LLC
    Atlanta, Georgia 30328, United States
  • Infinite Clinical Trials
    Morrow, Georgia 30260, United States
  • Javara Inc / Privia Medical Group Georgia, LLC
    Pooler, Georgia 31322, United States
  • WR-Mount Vernon Clinical Research, LLC
    Sandy Springs, Georgia 30328, United States
  • Leavitt Clinical Research
    Idaho Falls, Idaho 83404, United States
  • Women's Healthcare Associates P.A.
    Idaho Falls, Idaho 83404, United States
  • The Iowa Clinic
    Ankeny, Iowa 50023, United States
  • Alliance for Multispecialty Research, LLC
    El Dorado, Kansas 67042, United States
  • Alliance for Multispecialty Research, LLC
    Newton, Kansas 67114, United States
  • Alliance for Multispecialty Research, LLC
    Wichita, Kansas 67205, United States
  • Alliance for Multispecialty Research, LLC
    Wichita, Kansas 67207, United States
  • Alliance for Multispecialty Research, LLC - Lexington
    Lexington, Kentucky 40509, United States
  • Velocity Clinical Research - Covington
    Covington, Louisiana 70433, United States
  • Velocity Clinical Research
    Lafayette, Louisiana 70508, United States
  • Southern Clinical Research Associates
    Metairie, Louisiana 70001, United States
  • Velocity Clinical Research
    Metairie, Louisiana 70006, United States
  • Alliance for Multispecialty Research, LLC
    New Orleans, Louisiana 70119, United States
  • Velocity Clinical Research
    Slidell, Louisiana 70458, United States
  • Continental Clinical Solutions
    Towson, Maryland 21204, United States
  • NECCR PrimaCare Research, LLC
    Fall River, Massachusetts 02721, United States
  • Exordia Medical Research, Inc
    Fall River, Massachusetts 02723, United States
  • Velocity Clinical Research
    Gulfport, Mississippi 39503, United States
  • Alliance for Multispecialty Research, LLC
    Kansas City, Missouri 64114, United States
  • Velocity Clinical Research
    Grand Island, Nebraska 68803, United States
  • Velocity Clinical Research
    Hastings, Nebraska 68901, United States
  • Velocity Clinical Research
    Omaha, Nebraska 68134, United States
  • Jubilee Clinical Research, Inc
    Las Vegas, Nevada 89106, United States
  • Essential Women's Health Associates
    Las Vegas, Nevada 89113, United States
  • Alliance for Multispecialty Research, LLC
    Las Vegas, Nevada 89119, United States
  • Planned Parenthood of Northern, Central, and Southern New Jersey
    Perth Amboy, New Jersey 08861, United States
  • Albuquerque Clinical Trials, Inc
    Albuquerque, New Mexico 87102, United States
  • Bosque Women's Care
    Albuquerque, New Mexico 87109, United States
  • Meridian Clinical Research, LLC
    Vestal, New York 13850, United States
  • Carolina Women's Research and Wellness Center
    Durham, North Carolina 27713, United States
  • Carolina Institute For Clinical Research
    Fayetteville, North Carolina 28303, United States
  • M3 Wake Research, Inc
    Raleigh, North Carolina 27612, United States
  • University of Cincinnati Physicians
    Cincinnati, Ohio 45267, United States
  • OB/GYN Associates of Erie
    Erie, Pennsylvania 16507, United States
  • Clinical Research of Philadelphia, LLC
    Philadelphia, Pennsylvania 19114, United States
  • Venus Gynecology, LLC
    Myrtle Beach, South Carolina 29572, United States
  • Chattanooga Medical Research, LLC
    Chattanooga, Tennessee 37404, United States
  • Alliance for Multispecialty Research, LLC
    Knoxville, Tennessee 37909, United States
  • New Phase Research & Development
    Knoxville, Tennessee 37909, United States
  • WR-Medical Research Center of Memphis
    Memphis, Tennessee 38120, United States
  • Tekton Research, Inc
    Austin, Texas 78705, United States
  • Helios Clinical Research
    Burleson, Texas 76028, United States
  • Cedar Health Research
    Dallas, Texas 75251, United States
  • Helios Clinical Research
    Fort Worth, Texas 76104, United States
  • Javara Inc
    Houston, Texas 77054, United States
  • Accurate Clinical Research, Inc
    Houston, Texas 77065, United States
  • Clinical Trial Network
    Houston, Texas 77074, United States
  • Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas
    Rowlett, Texas 75088, United States
  • Tekton Research, Inc
    San Antonio, Texas 78229, United States
  • Javara Research
    Stephenville, Texas 76401, United States
  • Javara Inc
    Sugar Land, Texas 77478, United States
  • Helios Clinical Research - Weatherford
    Weatherford, Texas 76086, United States
  • Wasatch Clinical Research
    Salt Lake City, Utah 84107, United States
  • Javara Research
    Forest, Virginia 24551, United States

Showing the first 100 of 103 sites.

09

References and documents

Study documents

  • Study protocol · Aug 30, 2022
  • Statistical analysis plan · Apr 23, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05264506
Lead sponsor
Organon and Co
Collaborators
IQVIA Pty Ltd
Responsible party
Sponsor
First posted
Mar 3, 2022
Start date
Feb 17, 2022
Primary completion
Jan 12, 2024
Completion
Jan 26, 2024
Results posted
Nov 21, 2025
Last update
Nov 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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