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)

  • End date
    Mar 23, 2024
  • participants needed
  • sponsor
    Organon and Co
Updated on 23 October 2022
regular menstrual cycles
combined oral contraceptives
nomegestrol acetate


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.

Condition Contraception
Treatment NOMAC-E2 COC
Clinical Study IdentifierNCT05264506
SponsorOrganon and Co
Last Modified on23 October 2022


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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
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