Your session is about to expire
← Back to Search
Combined Oral Contraceptive
NOMAC-E2 COC for Birth Control
Phase 3
Waitlist Available
Research Sponsored by Organon and Co
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenarcheal, premenopausal female aged 14 to 35 years (inclusive)
No desire for pregnancy within 1 year following screening and is not intending to use any other form of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying how well a new birth control pill, NOMAC-E2, works in healthy females aged 14-35.
Who is the study for?
This trial is for premenopausal females aged 14 to 35 who are in good health, sexually active, not planning a pregnancy within the next year, and have regular menstrual cycles. They should not be using other contraceptives or have conditions like untreated STDs, significant liver disease, history of certain cardiovascular issues or cancers, severe depression or allergies to NOMAC-E2.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of a birth control pill called NOMAC-E2 COC in preventing pregnancy. Participants will use this oral contraceptive and their experience with it will be monitored to assess how well it works and its safety profile.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for oral contraceptives can include nausea, headaches, breast tenderness, weight gain, mood changes and irregular bleeding. More serious but rare risks involve blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 14-35 and have started menstruating but have not reached menopause.
Select...
I do not plan to become pregnant in the next year and won't use other birth control methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
By-cycle summary of bleeding-spotting
By-reference period summary of frequency of bleeding/spotting episodes
By-reference period summary of subjects with prolonged bleeding spotting
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)Experimental Treatment1 Intervention
The NOMAC-E2 COC active tablets contain 2.5 mg NOMAC and 1.5 mg E2 and will be used in a 24/4 regimen, i.e., 28-day cycles with 24 days of active tablet intake followed by 4 days of placebo tablet intake.
Find a Location
Who is running the clinical trial?
OSTAtisticsUNKNOWN
Organon and CoLead Sponsor
491 Previous Clinical Trials
1,730,889 Total Patients Enrolled
IQVIA Inc.UNKNOWN
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clots or heart-related issues.I have severe depression but it's currently stable and I have no symptoms.You have an allergy or sensitivity to NOMAC-E2.I do not plan to become pregnant in the next year and won't use other birth control methods.You have a higher risk of developing blood clots.I have very high or very low blood fat levels.I have had cancer within the last 5 years.I have several risk factors for heart disease.I have or had a serious liver condition.I have not been treated for gonorrhea, chlamydia, or trichomonas.I have diabetes with complications or it has lasted more than 20 years.If you are currently breastfeeding or have breastfed within the past two months, you cannot participate in the study.I am HIV positive.I have had pancreatitis due to very high triglyceride levels.I have had surgery that affects how my body absorbs food.I am in good physical and mental health.I plan to use birth control or liver enzyme-inducing drugs during the study.I am a woman aged 14-35 and have started menstruating but have not reached menopause.I have had vaginal bleeding that hasn't been explained or resolved.You have had trouble getting pregnant or have been unable to get pregnant in the past.My high blood pressure is severe or not under control.You have taken another experimental drug within the past two months.I have had fewer than 2 menstrual cycles since my recent pregnancy.You have had a problem with drugs or alcohol in the past 2 years.I have had migraines with visual disturbances or specific neurological symptoms.I have or had a meningioma.My condition gets worse with hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Birth Control Patient Testimony for trial: Trial Name: NCT05264506 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would someone aged 41 years or older still be able to participate in this research project?
"In order to be eligible for this particular trial, patients must between the ages of 14 to 35--22 trials exist for those under 18 and 16 for those over 65."
Answered by AI
What is the official governmental opinion on NOMAC-E2 COC?
"There is both existing data to support the efficacy of NOMAC-E2 COC and also multiple rounds of safety data, so it received a score of 3."
Answered by AI
Are there any patients this research cannot be conducted on?
"This clinical trial is open to 1878 participants between the ages of 14 and 35. To be eligible, participants must meet the following 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, 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."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Comprehensive Clinical Trials, LLC
Tekton Research, Inc
Ventavia Research Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I need a birth control that works for me.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
what is the pay out?
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger