NOMAC-E2 COC for Contraception

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Contraception
NOMAC-E2 COC - Drug
Eligibility
< 65
Female
What conditions do you have?
Select

Study Summary

This trial is studying how well a new birth control pill, NOMAC-E2, works in healthy females aged 14-35.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 1 year

1 year
Therapeutic procedure
Number of on-treatment pregnancies per 100 women
Therapeutic procedure
Number of pregnancies during perfect use cycles per 100 women-years
Number of pregnancies with participants placed in subgroups based on baseline BMI categories (<30 kg/m2, ≥30 kg/m2)
Proportion of participants who prematurely discontinue study drug treatment
Proportion of participants with an adverse event (regardless on potential relationship to study drug)
28-day cycles across one year
By-cycle summary of bleeding-spotting
91-day reference periods across one year
By-reference period summary of frequency of bleeding/spotting episodes
By-reference period summary of subjects with prolonged bleeding spotting
By-reference period summary of the bleeding and/or spotting days
Week 17
NOMAC concentrations - relationship with BMI
NOMAC concentrations - relationship with body weight

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
1 of 1
Experimental Treatment

1878 Total Participants · 1 Treatment Group

Primary Treatment: NOMAC-E2 COC · No Placebo Group · Phase 3

Nomegestrol Acetate + 17β-estradiol (NOMAC-E2; OG-8175A)
Drug
Experimental Group · 1 Intervention: NOMAC-E2 COC · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

OSTAtisticsUNKNOWN
Organon and CoLead Sponsor
489 Previous Clinical Trials
1,730,256 Total Patients Enrolled
22 Trials studying Contraception
21,216 Patients Enrolled for Contraception
IQVIA Inc.UNKNOWN

Eligibility Criteria

Age < 65 · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at risk for pregnancy.
You have regular menstrual cycles prior to the use of any hormonal contraceptive.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Comprehensive Clinical Trials, LLC100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%