Clinical trial NCT05264506: Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Contraception
Keywords: Birth control methods
Contraceptive
Postmenarcheal Premenopausal Women
Hormonal
Sexually Active
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Inc.
name: OSTAtistics
First posted: 2022-03-03
Enrollment: 2007
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm Study
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of on-treatment pregnancies per 100 women-years of at risk exposure
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of participants with an adverse event (regardless on potential relationship to study drug)
timeFrame: 1 year
measure: Proportion of participants who prematurely discontinue study drug treatment
timeFrame: 1 year
measure: Number of pregnancies during perfect use cycles per 100 women-years
timeFrame: 1 year
measure: Number of all on-treatment pregnancies per 100 years of exposure
timeFrame: 1 year
measure: Number of pregnancies with participants placed in subgroups based on baseline BMI categories (<30 kg/m2, ≥30 kg/m2)
timeFrame: 1 year
measure: By-cycle summary of bleeding-spotting
timeFrame: 28-day cycles across one year
measure: By-reference period summary of the bleeding and/or spotting days
timeFrame: 91-day reference periods across one year
measure: By-reference period summary of frequency of bleeding/spotting episodes
timeFrame: 91-day reference periods across one year
measure: By-reference period summary of subjects with prolonged bleeding spotting
timeFrame: 91-day reference periods across one year
measure: NOMAC concentrations - relationship with body weight
timeFrame: Treatment Week 5 and Treatment Week 17
measure: NOMAC concentrations - relationship with BMI
timeFrame: Treatment Week 5 and Treatment Week 17
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research, LLC/CCT Research
state: Arizona
city: Phoenix
country: United States
facility: Velocity Clinical Research - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Bell Gardens
country: United States
facility: Gardens Medical Center / Alliance Research Institute
state: California
city: Canoga Park
country: United States
facility: Alliance Research Institute, LLC
state: California
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: San Diego
country: United States
facility: WR-Women's Health Care Research, LLC
state: California
city: San Diego
country: United States
facility: WR-Medical Center For Clinical Research - San Diego
state: California
city: Denver
country: United States
facility: Velocity Clinical Research
state: Colorado
city: Lakewood
country: United States
facility: Physicians' Research Options / Red Rocks OB/GYN
state: Colorado
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc.
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - St. Petersburg Clinical Research Unit
state: Florida
city: Leesburg
country: United States
facility: OB-GYN Associates of Mid-Florida, PA
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Miami Lakes
country: United States
facility: Quality Research of South Florida
state: Florida
city: Miami
country: United States
facility: Avantis Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Admed Research, LLC
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
state: Florida
city: Miami
country: United States
facility: Spotlight Research Center, LLC
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Tampa
country: United States
facility: R & B Medical Center LLC
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Morrow
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Pooler
country: United States
facility: Javara Inc / Privia Medical Group Georgia, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates P.A.
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC - Lexington
state: Kentucky
city: Covington
country: United States
facility: Velocity Clinical Research - Covington
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Slidell
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Solutions
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research, LLC
state: Massachusetts
city: Fall River
country: United States
facility: Exordia Medical Research, Inc
state: Massachusetts
city: Gulfport
country: United States
facility: Velocity Clinical Research
state: Mississippi
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Grand Island
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Hastings
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Las Vegas
country: United States
facility: Essential Women's Health Associates
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Perth Amboy
country: United States
facility: Planned Parenthood of Northern, Central, and Southern New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute For Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians
state: Ohio
city: Erie
country: United States
facility: OB/GYN Associates of Erie
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Burleson
country: United States
facility: Helios Clinical Research
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Fort Worth
country: United States
facility: Helios Clinical Research
state: Texas
city: Houston
country: United States
facility: Javara Inc
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Rowlett
country: United States
facility: Texas Health Care, PLLC d/b/d Privia Medical Group - North Texas
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc
state: Texas
city: Stephenville
country: United States
facility: Javara Research
state: Texas
city: Sugar Land
country: United States
facility: Javara Inc
state: Texas
city: Weatherford
country: United States
facility: Helios Clinical Research - Weatherford
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Forest
country: United States
facility: Javara Research
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Clinical Research
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
Study officials:
References: