Status:
TERMINATED
Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Contraception
Eligibility:
FEMALE
14-35 years
Phase:
PHASE3
Brief 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).
Detailed Description
This is a Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2024
Estimated Enrollment :
3055 Patients enrolled
Trial Details
Trial ID
NCT05264506
Start Date
February 17 2022
End Date
January 26 2024
Last Update
November 21 2025
Active Locations (103)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
SEC Clinical Research
Dothan, Alabama, United States, 36305
3
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
4
Velocity Clinical Research
Mobile, Alabama, United States, 36608