Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

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)

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).

Study Overview

• Status: Terminated
• Conditions: Contraception
• Intervention / Treatment: Drug: NOMAC-E2 COC

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.

• Study Type: Interventional
• Enrollment (Actual): 2007
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sebastian Mirkin, MD; Phone Number: 561-862-7446; Email: sebastian.mirkin@organon.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • SEC Clinical Research
    • Mobile, Alabama, United States, 36608
      • Alliance for Multispecialty Research, LLC
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Mesa Obstetricians and Gynecologists
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research, LLC/CCT Research
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ, LLC
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research - Phoenix
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • California
    • Bell Gardens, California, United States, 90201
      • Gardens Medical Center / Alliance Research Institute
    • Canoga Park, California, United States, 91304
      • Alliance Research Institute, LLC
    • Hawthorne, California, United States, 90250
      • Advanced Investigative Medicine, Inc
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • San Diego, California, United States, 92111
      • WR-Women's Health Care Research, LLC
    • San Diego, California, United States, 92120
      • WR-Medical Center For Clinical Research - San Diego
  • Colorado
    • Denver, Colorado, United States, 80209
      • Velocity Clinical Research
    • Lakewood, Colorado, United States, 80228
      • Physicians' Research Options / Red Rocks OB/GYN
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven, LLC
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Alliance for Multispecialty Research, LLC
    • Doral, Florida, United States, 33166
      • Universal Axon Clinical Research, LLC
    • Fort Myers, Florida, United States, 33912
      • Alliance for Multispecialty Research, LLC
    • Lake Worth, Florida, United States, 33461
      • Altus Research, Inc.
    • Largo, Florida, United States, 33777
      • Accel Research Sites - St. Petersburg Clinical Research Unit
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida, PA
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33176
      • Spotlight Research Center, LLC
    • Miami, Florida, United States, 33173
      • Genoma Research Group, Inc.
    • Miami, Florida, United States, 33173
      • Admed Research, LLC
    • Miami, Florida, United States, 33155
      • Avantis Clinical Research, LLC
    • Miami Beach, Florida, United States, 33140
      • Quantum Clinical Trials
    • Miami Lakes, Florida, United States, 33016
      • Quality Research of South Florida
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data, Inc.
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida
    • Tampa, Florida, United States, 33614
      • R & B Medical Center LLC
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials, LLC
    • Morrow, Georgia, United States, 30260
      • Infinite Clinical Trials
    • Pooler, Georgia, United States, 31322
      • Javara Inc / Privia Medical Group Georgia, LLC
    • Sandy Springs, Georgia, United States, 30328
      • WR-Mount Vernon Clinical Research, LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Women's Healthcare Associates P.A.
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Iowa
    • Ankeny, Iowa, United States, 50023
      • The Iowa Clinic
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Alliance for Multispecialty Research, LLC
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research, LLC
    • Wichita, Kansas, United States, 67205
      • Alliance for Multispecialty Research, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC - Lexington
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research - Covington
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
    • Metairie, Louisiana, United States, 70006
      • Velocity Clinical Research
    • New Orleans, Louisiana, United States, 70119
      • Alliance for Multispecialty Research, LLC
    • Slidell, Louisiana, United States, 70458
      • Velocity Clinical Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research, LLC
    • Fall River, Massachusetts, United States, 02723
      • Exordia Medical Research, Inc
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Velocity Clinical Research
    • Hastings, Nebraska, United States, 68901
      • Velocity Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research, Inc
    • Las Vegas, Nevada, United States, 89113
      • Essential Women's Health Associates
  • New Jersey
    • Perth Amboy, New Jersey, United States, 08861
      • Planned Parenthood of Northern, Central, and Southern New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc
  • New York
    • Vestal, New York, United States, 13850
      • Meridian Clinical Research, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research and Wellness Center
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Physicians
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • OB/GYN Associates of Erie
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Venus Gynecology, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, Llc
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Research, LLC
    • Memphis, Tennessee, United States, 38120
      • WR-Medical Research Center of Memphis
  • Texas
    • Austin, Texas, United States, 78705
      • Tekton Research, Inc
    • Burleson, Texas, United States, 76028
      • Helios Clinical Research
    • Dallas, Texas, United States, 75251
      • Cedar Health Research
    • Fort Worth, Texas, United States, 76104
      • Helios Clinical Research
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77054
      • Javara Inc
    • Houston, Texas, United States, 77065
      • Accurate Clinical Research, Inc
    • Rowlett, Texas, United States, 75088
      • Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas
    • San Antonio, Texas, United States, 78229
      • Tekton Research, Inc
    • Stephenville, Texas, United States, 76401
      • Javara Research
    • Sugar Land, Texas, United States, 77478
      • Javara Inc
    • Weatherford, Texas, United States, 76086
      • Helios Clinical Research - Weatherford
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Forest, Virginia, United States, 24551
      • Javara Research
    • Norfolk, Virginia, United States, 23502
      • Alliance for Multispecialty Research, LLC
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.; Other Names: Nomegestrol acetate / estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of on-treatment pregnancies per 100 women-years of at risk exposure	The at-risk Pearl Index is defined as the number of on-treatment pregnancies (i.e., pregnancies from study drug start to 7 days after last intake of active study drug) divided by the number of 28-day cycles, either associated with a pregnancy or with both affirmed heterosexual vaginal intercourse and no use of additional contraception, with that number multiplied by 1300 to represent the number for 100 years of 13 cycles per year.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of pregnancies during perfect use cycles per 100 women-years	The perfect use Pearl Index is similar to the at-risk Pearl Index, but excludes subjects or select cycles per subject, from both the number of pregnancies and the number of cycles, where important deviations from the protocol have occurred. Important deviations for contraceptive cycles can include, but not be limited to, (a) non-compliance based on 4 missed active tablets during cycle, (b) non-compliance based on 2 consecutive missed active tablets during a cycle, (c) prohibited medications taken during the cycle. Important subject deviations for contraceptive analysis include, but not limited to, (a) >75% of cycles where participant is non-compliant with study drug or not at risk for pregnancy, (b) participant is pregnant or without documented negative pregnancy on day of first study drug intake, (c) participant did not meet eligibility requires for absence of abnormal bleeding or breastfeeding.	1 year
Number of all on-treatment pregnancies per 100 years of exposure	The typical-use Pearl Index is defined as the number of on-treatment pregnancies divided by the number of 28-day cycles, regardless of affirmed heterosexual vaginal intercourse or no use of additional contraception, with that number multiplied by 1300 to represent the number for 100 years of 13 cycles per year.	1 year
Number of pregnancies with participants placed in subgroups based on baseline BMI categories (<30 kg/m2, ≥30 kg/m2)	Each of the three Pearl Index measures previously described will be evaluated separately for participant with body mass index values of <30 kg/m2 and ≥ 30kg/m2, with the value as determined at the time of assignment to treatment.	1 year
By-cycle summary of bleeding-spotting	For each cycle, the number of participants will be summarized according to the bleeding-spotting patterns (unscheduled bleeding-spotting, absence of scheduled bleeding-spotting, experienced no scheduled or unscheduled bleeding-spotting at all) observed during the cycle.	28-day cycles across one year
By-reference period summary of the bleeding and/or spotting days	For each 91-day reference period, the number of bleeding days, spotting days, and bleeding-spotting days will be summarized.	91-day reference periods across one year
By-reference period summary of frequency of bleeding/spotting episodes	Bleeding/spotting patterns during the 91-day reference periods will be classified as no episodes, 1-2 episodes, 3-5 episodes, and >5 episodes, where episodes are defined as one or more consecutive days during which bleeding or spotting occurred, bounded at each end by bleeding-spotting-free days.	91-day reference periods across one year
By-reference period summary of subjects with prolonged bleeding spotting	Bleeding/spotting patterns during the 91-day reference periods will be classified as based on at least one bleeding/spotting starting with the reference period, where a length of >7 days and of >14 days will be evaluated.	91-day reference periods across one year
NOMAC concentrations - relationship with body weight	NOMAC concentrations assessed through use of sparse sampling and population pharmacokinetic modeling to estimate the effect of body weight (kg).	Treatment Week 5 and Treatment Week 17
NOMAC concentrations - relationship with BMI	NOMAC concentrations assessed through use of sparse sampling and population pharmacokinetic modeling to estimate the effect of BMI (kg/m^2).	Treatment Week 5 and Treatment Week 17

Collaborators and Investigators

• Sponsor: Organon and Co
• Collaborators: IQVIA Inc.; OSTAtistics

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Contraceptive; Birth control methods; Postmenarcheal Premenopausal Women; Hormonal; Sexually Active
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: OG-8175A-023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No