Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

NCT05264506 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: OG-8175A-023
• Study Type: interventional
• Target: 3,055
• Locations: 1 country
• Sites: 103

Brief 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).

Conditions

Contraception

Keywords

Birth control methods; Contraceptive; Postmenarcheal Premenopausal Women; Hormonal; Sexually Active

Outcome Measures

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

  1 year

Secondary Outcomes (13)

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

  1 year

• Proportion of Participants Who Prematurely Discontinue Study Drug Treatment

  1 year

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

  1 year

• Number of Cycles of Exposure Prior to Pregnancy

  1 year

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

  1 year

Study Arms (1)

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

EXPERIMENTAL

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

NOMAC-E2 COC DRUG

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

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

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead
• Iqvia Pty Ltd: collaborator

Study Sites (103)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

SEC Clinical Research

Dothan, Alabama, 36305, United States

Location

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Mesa Obstetricians and Gynecologists

Mesa, Arizona, 85206, United States

Location

Desert Clinical Research, LLC/CCT Research

Mesa, Arizona, 85213, United States

Location

Velocity Clinical Research - Phoenix

Phoenix, Arizona, 85006, United States

Location

Precision Trials AZ, LLC

Phoenix, Arizona, 85032, United States

Location

Alliance for Multispecialty Research

Tempe, Arizona, 85281, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Gardens Medical Center / Alliance Research Institute

Bell Gardens, California, 90201, United States

Location

Alliance Research Institute, LLC

Canoga Park, California, 91304, United States

Location

Advanced Investigative Medicine, Inc

Hawthorne, California, 90250, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

WR-Women's Health Care Research, LLC

San Diego, California, 92111, United States

Location

WR-Medical Center For Clinical Research - San Diego

San Diego, California, 92120, United States

Location

Velocity Clinical Research

Denver, Colorado, 80209, United States

Location

Physicians' Research Options / Red Rocks OB/GYN

Lakewood, Colorado, 80228, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, 33134, United States

Location

Universal Axon Clinical Research, LLC

Doral, Florida, 33166, United States

Location

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, 33912, United States

Location

Altus Research, Inc.

Lake Worth, Florida, 33461, United States

Location

Accel Research Sites - St. Petersburg Clinical Research Unit

Largo, Florida, 33777, United States

Location

OB-GYN Associates of Mid-Florida, PA

Leesburg, Florida, 34748, United States

Location

Avantis Clinical Research, LLC

Miami, Florida, 33155, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Admed Research, LLC

Miami, Florida, 33173, United States

Location

Genoma Research Group, Inc.

Miami, Florida, 33173, United States

Location

Spotlight Research Center, LLC

Miami, Florida, 33176, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

Quantum Clinical Trials

Miami Beach, Florida, 33140, United States

Location

Quality Research of South Florida

Miami Lakes, Florida, 33016, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Sensible Healthcare LLC

Ocoee, Florida, 34761, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

R & B Medical Center LLC

Tampa, Florida, 33614, United States

Location

Comprehensive Clinical Research, LLC

West Palm Beach, Florida, 33409, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

Infinite Clinical Trials

Morrow, Georgia, 30260, United States

Location

Javara Inc / Privia Medical Group Georgia, LLC

Pooler, Georgia, 31322, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Women's Healthcare Associates P.A.

Idaho Falls, Idaho, 83404, United States

Location

The Iowa Clinic

Ankeny, Iowa, 50023, United States

Location

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, 67042, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research, LLC - Lexington

Lexington, Kentucky, 40509, United States

Location

Velocity Clinical Research - Covington

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Velocity Clinical Research

Metairie, Louisiana, 70006, United States

Location

Alliance for Multispecialty Research, LLC

New Orleans, Louisiana, 70119, United States

Location

Velocity Clinical Research

Slidell, Louisiana, 70458, United States

Location

Continental Clinical Solutions

Towson, Maryland, 21204, United States

Location

NECCR PrimaCare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Exordia Medical Research, Inc

Fall River, Massachusetts, 02723, United States

Location

Velocity Clinical Research

Gulfport, Mississippi, 39503, United States

Location

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, 64114, United States

Location

Velocity Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research

Hastings, Nebraska, 68901, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Jubilee Clinical Research, Inc

Las Vegas, Nevada, 89106, United States

Location

Essential Women's Health Associates

Las Vegas, Nevada, 89113, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Planned Parenthood of Northern, Central, and Southern New Jersey

Perth Amboy, New Jersey, 08861, United States

Location

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, 87102, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

Meridian Clinical Research, LLC

Vestal, New York, 13850, United States

Location

Carolina Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

Location

Carolina Institute For Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati Physicians

Cincinnati, Ohio, 45267, United States

Location

OB/GYN Associates of Erie

Erie, Pennsylvania, 16507, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Venus Gynecology, LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37909, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

WR-Medical Research Center of Memphis

Memphis, Tennessee, 38120, United States

Location

Tekton Research, Inc

Austin, Texas, 78705, United States

Location

Helios Clinical Research

Burleson, Texas, 76028, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

Helios Clinical Research

Fort Worth, Texas, 76104, United States

Location

Javara Inc

Houston, Texas, 77054, United States

Location

Accurate Clinical Research, Inc

Houston, Texas, 77065, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas

Rowlett, Texas, 75088, United States

Location

Tekton Research, Inc

San Antonio, Texas, 78229, United States

Location

Javara Research

Stephenville, Texas, 76401, United States

Location

Javara Inc

Sugar Land, Texas, 77478, United States

Location

Helios Clinical Research - Weatherford

Weatherford, Texas, 76086, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Javara Research

Forest, Virginia, 24551, United States

Location

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, 23502, United States

Location

Tidewater Clinical Research

Norfolk, Virginia, 23502, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

nomegestrol acetate; Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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.

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm Study

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 3, 2022
• Study Start: February 17, 2022
• Primary Completion: January 12, 2024
• Study Completion: January 26, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (103)