Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Contraception

In brief

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).

Key facts

Study ID

NCT05264506

Run by

Organon and Co

People needed

3055

Starts

2022-02-17

Expected to finish

2024-01-26

Last updated by the study team

2025-11-21

Who can join

Age: 14 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SEC Clinical Research — Dothan, Alabama, United States
• Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
• Velocity Clinical Research — Mobile, Alabama, United States
• Mesa Obstetricians and Gynecologists — Mesa, Arizona, United States
• Desert Clinical Research, LLC/CCT Research — Mesa, Arizona, United States
• Velocity Clinical Research - Phoenix — Phoenix, Arizona, United States
• Precision Trials AZ, LLC — Phoenix, Arizona, United States
• Alliance for Multispecialty Research — Tempe, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Gardens Medical Center / Alliance Research Institute — Bell Gardens, California, United States
• Alliance Research Institute, LLC — Canoga Park, California, United States
• Advanced Investigative Medicine, Inc — Hawthorne, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• Om Research LLC — Lancaster, California, United States
• Empire Clinical Research — Pomona, California, United States
• WR-Women's Health Care Research, LLC — San Diego, California, United States
• WR-Medical Center For Clinical Research - San Diego — San Diego, California, United States
• Velocity Clinical Research — Denver, Colorado, United States
• Physicians' Research Options / Red Rocks OB/GYN — Lakewood, Colorado, United States
• CMR of Greater New Haven, LLC — Hamden, Connecticut, United States
• Alliance for Multispecialty Research, LLC — Coral Gables, Florida, United States
• Universal Axon Clinical Research, LLC — Doral, Florida, United States
• Alliance for Multispecialty Research, LLC — Fort Myers, Florida, United States
• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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