Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (NCT05264506) | Clinical Trial Compass
TerminatedPhase 3
Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
Stopped: Sponsor decision to stop the study early and complete all required study close-out activities. This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed.
United States3,055 participantsStarted 2022-02-17
Plain-language 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).
Who can participate
Age range
14 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/hi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With On-treatment Pregnancies