Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

Inclusion Criteria:

• Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive)
• At risk for pregnancy (including heterosexual vaginal intercourse at least once amonth and not sterilized).
• No desire for pregnancy within 1 year following screening and is not intending to useany 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, orclaudication
• 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 liverenzymes during study
• Used another investigational drug within 2 months of study drug start