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 range14 Years – 35 Years
SexFEMALE
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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…
What they're measuring
1
Number of Participants With On-treatment Pregnancies