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).
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
3,055
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.
Number of Participants With On-treatment Pregnancies
Raw count of the number of pregnancies that occurred while participants were taking study drug
Time frame: 1 year
Proportion of Participants With an Adverse Event (Regardless on Potential Relationship to Study Drug)
Time frame: 1 year
Proportion of Participants Who Prematurely Discontinue Study Drug Treatment
Time frame: 1 year
Percentage of Participants With On-treatment Pregnancies With at Least One Completed Cycle
Number of participants with on-treatment pregnancies as a percentage of the number of participants with at least one completed cycle
Time frame: 1 year
Number of Cycles of Exposure Prior to Pregnancy
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)
Time frame: 1 year
Number of Participants With a Pregnancy, Based on Baseline BMI Categories (<30 kg/m2, ≥30 kg/m2)
Raw count of the number of pregnancies that occurred while participants were taking study drug in each BMI category
Time frame: 1 year
Proportion of Participants With Bleeding-spotting Days
Number of participants with bleeding-spotting days as a proportion of the number of participants who had at least one completed cycle
Time frame: 28-day cycles across one year
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
SEC Clinical Research
Dothan, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Velocity Clinical Research
Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists
Mesa, Arizona, United States
Desert Clinical Research, LLC/CCT Research
Mesa, Arizona, United States
Velocity Clinical Research - Phoenix
Phoenix, Arizona, United States
Precision Trials AZ, LLC
Phoenix, Arizona, United States
Alliance for Multispecialty Research
Tempe, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
...and 93 more locations
Mean Number of Bleeding and/or Spotting Days Per Cycle
For participants who had at least one completed cycle, the mean number of bleeding-spotting days per cycle
Time frame: 28-day cycles across one year
Average Number of Bleeding-spotting Days Per Reference Period
For participants with at least one completed reference period, the average number of bleeding-spotting days per reference period
Time frame: 91-day reference periods across one year
Proportion of Participants With 8 or More Bleeding-spotting Days
Proportion of participants who had at least one completed cycle with 8 or more bleeding-spotting days in a cycle
Time frame: 28-day cycles across one year
Mean NOMAC Concentration, Visit 3 Pre-Dose
NOMAC concentrations assessed through use of sparse sampling
Time frame: Treatment Week 5
Mean NOMAC Concentration, Visit 3 Post-Dose
NOMAC concentrations assessed through use of sparse sampling
Time frame: Treatment Week 5
Mean NOMAC Concentration, Visit 4 Pre-Dose
NOMAC concentrations assessed through use of sparse sampling
Time frame: Treatment Week 17
Mean NOMAC Concentration, Visit 4 Post-Dose
NOMAC concentrations assessed through use of sparse sampling
Time frame: Treatment Week 17