Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Organon and Co
• Collaborator: IQVIA Inc.
• Treatments: Estradiol

Criteria

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