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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05264506
Other study ID # OG-8175A-023
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 17, 2022
Est. completion date January 26, 2024

Study information

Verified date February 2024
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2007
Est. completion date January 26, 2024
Est. primary completion date January 12, 2024
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Albuquerque Clinical Trials, Inc Albuquerque New Mexico
United States Bosque Women's Care Albuquerque New Mexico
United States The Iowa Clinic Ankeny Iowa
United States Agile Clinical Research Trials, LLC Atlanta Georgia
United States Tekton Research, Inc Austin Texas
United States Gardens Medical Center / Alliance Research Institute Bell Gardens California
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States Helios Clinical Research Burleson Texas
United States Alliance Research Institute, LLC Canoga Park California
United States Chattanooga Medical Research, LLC Chattanooga Tennessee
United States University of Cincinnati Physicians Cincinnati Ohio
United States Alliance for Multispecialty Research, LLC Coral Gables Florida
United States Velocity Clinical Research - Covington Covington Louisiana
United States Cedar Health Research Dallas Texas
United States Velocity Clinical Research Denver Colorado
United States Universal Axon Clinical Research, LLC Doral Florida
United States SEC Clinical Research Dothan Alabama
United States Carolina Women's Research and Wellness Center Durham North Carolina
United States Alliance for Multispecialty Research, LLC El Dorado Kansas
United States OB/GYN Associates of Erie Erie Pennsylvania
United States Exordia Medical Research, Inc Fall River Massachusetts
United States NECCR PrimaCare Research, LLC Fall River Massachusetts
United States Carolina Institute For Clinical Research Fayetteville North Carolina
United States Javara Research Forest Virginia
United States Alliance for Multispecialty Research, LLC Fort Myers Florida
United States Helios Clinical Research Fort Worth Texas
United States Velocity Clinical Research Grand Island Nebraska
United States Velocity Clinical Research Gulfport Mississippi
United States CMR of Greater New Haven, LLC Hamden Connecticut
United States Velocity Clinical Research Hastings Nebraska
United States Advanced Investigative Medicine, Inc Hawthorne California
United States Accurate Clinical Research, Inc Houston Texas
United States Clinical Trial Network Houston Texas
United States Javara Inc Houston Texas
United States Marvel Clinical Research Huntington Beach California
United States Leavitt Clinical Research Idaho Falls Idaho
United States Women's Healthcare Associates P.A. Idaho Falls Idaho
United States Alliance for Multispecialty Research, LLC Kansas City Missouri
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States New Phase Research & Development Knoxville Tennessee
United States Velocity Clinical Research Lafayette Louisiana
United States Altus Research, Inc. Lake Worth Florida
United States Physicians' Research Options / Red Rocks OB/GYN Lakewood Colorado
United States Om Research LLC Lancaster California
United States Accel Research Sites - St. Petersburg Clinical Research Unit Largo Florida
United States Alliance for Multispecialty Research, LLC Las Vegas Nevada
United States Essential Women's Health Associates Las Vegas Nevada
United States Jubilee Clinical Research, Inc Las Vegas Nevada
United States OB-GYN Associates of Mid-Florida, PA Leesburg Florida
United States Alliance for Multispecialty Research, LLC - Lexington Lexington Kentucky
United States WR-Medical Research Center of Memphis Memphis Tennessee
United States Desert Clinical Research, LLC/CCT Research Mesa Arizona
United States Mesa Obstetricians and Gynecologists Mesa Arizona
United States Southern Clinical Research Associates Metairie Louisiana
United States Velocity Clinical Research Metairie Louisiana
United States Admed Research, LLC Miami Florida
United States Avantis Clinical Research, LLC Miami Florida
United States Genoma Research Group, Inc. Miami Florida
United States Miami Clinical Research Miami Florida
United States New Age Medical Research Corporation Miami Florida
United States Spotlight Research Center, LLC Miami Florida
United States Quantum Clinical Trials Miami Beach Florida
United States Quality Research of South Florida Miami Lakes Florida
United States Alliance for Multispecialty Research, LLC Mobile Alabama
United States Velocity Clinical Research Mobile Alabama
United States Infinite Clinical Trials Morrow Georgia
United States Venus Gynecology, LLC Myrtle Beach South Carolina
United States Alliance for Multispecialty Research, LLC New Orleans Louisiana
United States Alliance for Multispecialty Research, LLC Newton Kansas
United States Alliance for Multispecialty Research, LLC Norfolk Virginia
United States Tidewater Clinical Research Norfolk Virginia
United States Healthcare Clinical Data, Inc. North Miami Florida
United States Sensible Healthcare LLC Ocoee Florida
United States Velocity Clinical Research Omaha Nebraska
United States Innovation Medical Research Center Palmetto Bay Florida
United States Planned Parenthood of Northern, Central, and Southern New Jersey Perth Amboy New Jersey
United States Clinical Research of Philadelphia, LLC Philadelphia Pennsylvania
United States Precision Trials AZ, LLC Phoenix Arizona
United States Velocity Clinical Research - Phoenix Phoenix Arizona
United States Empire Clinical Research Pomona California
United States Clinical Research Center of Florida Pompano Beach Florida
United States Javara Inc / Privia Medical Group Georgia, LLC Pooler Georgia
United States M3 Wake Research, Inc Raleigh North Carolina
United States Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas Rowlett Texas
United States Wasatch Clinical Research Salt Lake City Utah
United States Tekton Research, Inc San Antonio Texas
United States WR-Medical Center For Clinical Research - San Diego San Diego California
United States WR-Women's Health Care Research, LLC San Diego California
United States WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States Seattle Clinical Research Center Seattle Washington
United States Velocity Clinical Research Slidell Louisiana
United States Javara Research Stephenville Texas
United States Javara Inc Sugar Land Texas
United States R & B Medical Center LLC Tampa Florida
United States Alliance for Multispecialty Research Tempe Arizona
United States Continental Clinical Solutions Towson Maryland
United States Eclipse Clinical Research Tucson Arizona
United States Noble Clinical Research Tucson Arizona
United States Meridian Clinical Research, LLC Vestal New York
United States Helios Clinical Research - Weatherford Weatherford Texas
United States Comprehensive Clinical Research, LLC West Palm Beach Florida
United States Alliance for Multispecialty Research, LLC Wichita Kansas
United States Alliance for Multispecialty Research, LLC Wichita Kansas

Sponsors (3)

Lead Sponsor Collaborator
Organon and Co IQVIA Inc., OSTAtistics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion of participants with an adverse event (regardless on potential relationship to study drug) 1 year
Secondary Proportion of participants who prematurely discontinue study drug treatment 1 year
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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