Overview

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