Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
- 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).
- Short title
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Reason stopped
- 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.
- Completion date
- 2024-01-26
- First posted
- 2022-03-03
- Registry last updated
- 2025-11-21
- Primary completion date
- 2024-01-12
- Start date
- 2022-02-17
- Actual participants
- 3,055
- Participants
- 3,055
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Organon and Co
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05264506
- ClinicalTrials.gov ID
- NCT05264506
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Prevention
- Masking
- No masking
Number of Participants With On-treatment Pregnancies
Timeframe: 1 year
Raw count of the number of pregnancies that occurred while participants were taking study drug
Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
Timeframe: 1 year
Proportion of Participants Who Prematurely Discontinue Study Drug Treatment
Timeframe: 1 year
Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle
Timeframe: 1 year
Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle
Number of Cycles of Exposure Prior to Pregnancy
Timeframe: 1 year
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)
Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
Timeframe: 1 year
Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category
Proportion of Participants With Bleeding-spotting Days
Timeframe: 28-day cycles across one year
Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle
Mean Number of Bleeding and/or Spotting Days Per Cycle
Timeframe: 28-day cycles across one year
For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle
Average Number of Bleeding-spotting Days Per Reference Period
Timeframe: 91-day reference periods across one year
For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period
Proportion of Participants With 8 or More Bleeding-spotting Days
Timeframe: 28-day cycles across one year
Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle
Mean NOMAC Concentration, Visit 3 Pre-Dose
Timeframe: Treatment Week 5
NOMAC concentrations assessed through use of sparse sampling
Mean NOMAC Concentration, Visit 3 Post-Dose
Timeframe: Treatment Week 5
NOMAC concentrations assessed through use of sparse sampling
Mean NOMAC Concentration, Visit 4 Pre-Dose
Timeframe: Treatment Week 17
NOMAC concentrations assessed through use of sparse sampling
Mean NOMAC Concentration, Visit 4 Post-Dose
Timeframe: Treatment Week 17
NOMAC concentrations assessed through use of sparse sampling
- Sex
- Female
- Age groups
- Children, Adults
- Minimum age
- 14 Years
- Maximum age
- 35 Years
- Healthy volunteers
- No
- 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
- 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
- Alabama Clinical Therapeutics, LLCBirmingham, United States
- SEC Clinical ResearchDothan, United States
- Alliance for Multispecialty Research, LLCMobile, United States
- Velocity Clinical ResearchMobile, United States
- Mesa Obstetricians and GynecologistsMesa, United States
- Desert Clinical Research, LLC/CCT ResearchMesa, United States
- Velocity Clinical Research - PhoenixPhoenix, United States
- Precision Trials AZ, LLCPhoenix, United States
- Alliance for Multispecialty ResearchTempe, United States
- Noble Clinical ResearchTucson, United States
- Eclipse Clinical ResearchTucson, United States
- Gardens Medical Center / Alliance Research InstituteBell Gardens, United States
- Alliance Research Institute, LLCCanoga Park, United States
- Advanced Investigative Medicine, IncHawthorne, United States
- Marvel Clinical ResearchHuntington Beach, United States
- Om Research LLCLancaster, United States
- Empire Clinical ResearchPomona, United States
- WR-Women's Health Care Research, LLCSan Diego, United States
- WR-Medical Center For Clinical Research - San DiegoSan Diego, United States
- Velocity Clinical ResearchDenver, United States
- Physicians' Research Options / Red Rocks OB/GYNLakewood, United States
- CMR of Greater New Haven, LLCHamden, United States
- Alliance for Multispecialty Research, LLCCoral Gables, United States
- Universal Axon Clinical Research, LLCDoral, United States
- Alliance for Multispecialty Research, LLCFort Myers, United States
And 78 more, listed on the interactive page.
Related records
Drugs (1)
Collaborators (1)
- IQVIA Pty Ltd