About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive)
2. At risk for pregnancy (including heterosexual vaginal intercourse at least once a month and not sterilized).
3. No desire for pregnancy within 1 year following screening and is not intending to use any other form of contraception
4. Good physical and mental health
5. History of regular menstrual cycles prior to the use of any hormonal contraceptive.
6. Able and willing to adhere study procedures

Exclusion criteria

1. Current known or expected pregnancy
2. History of subfertility or infertility
3. Less than 2 normal menstrual cycles following recent pregnancy of gestational age
4. Breastfeeding within 2 months of study drug start
5. Known HIV infection
6. Untreated gonorrhea, chlamydia, or trichomonas
7. abnormal PAP within timeline of standard of care guidelines
8. Unexplained/unresolved abnormal vaginal bleeding
9. Presence/history of VTE, ATE, transient ischemic attack, angina pectoris, or claudication
10. Higher risk for VTE
11. Uncontrolled or severe hypertension
12. Severe dyslipoproteinemia
13. History of migraine with aura or focal neurological symptoms
14. Diabetes mellitus (with either end-organ involvement or >20 years duration)
15. Multiple cardiovascular risk factors
16. History of pancreatitis associated with severe hypertriglyceridemia
17. Presence/history of clinically significant liver disease
18. History of malabsorptive surgical procedures
19. History of malignancy in last 5 years
20. Presence/history of meningioma
21. Disease that may worsen under hormonal treatment
22. Presence/history of severe depression (unless currently stable and asymptomatic)
23. Known allergy/sensitivity to NOMAC-E2
24. Drug or alcohol abuse/dependence in last 2 years
25. Clinically relevant abnormal lab result at screening
26. Expected use of other contraceptive medications or medications that induce liver enzymes during study
27. Used another investigational drug within 2 months of study drug start

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.