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 Premenopausal Females Aged 14 to 35 Years (Inclusive)

  • STATUS
    Recruiting
  • End date
    Mar 23, 2024
  • participants needed
    1878
  • sponsor
    Organon and Co
Updated on 23 October 2022
regular menstrual cycles
combined oral contraceptives
estradiol
nomegestrol acetate

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).

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 Premenopausal Females Aged 14 to 35 Years (Inclusive). Potential participants must be sexually active and engage in heterosexual vaginal intercourse at least once per month with a partner who is not known to be subfertile, sterilized, or infertile, and should not routinely use any other form of contraception.

A total of 2,680 fertile premenopausal women aged 14 to 35 years (inclusive) will be screened to achieve about 1,878 (with at least 657 participants with BMI ≥30 kg/m2) being allocated to study treatment. Over 1,000 total participants are expected to complete 1 year of treatment (13 cycles).

The total duration of study participation will be up to 60 weeks, which includes a Pre-treatment Period of approximately 6 weeks, a Treatment Period of 52 weeks, and a Follow-up Period of 2 weeks after the last intake of study drug.

Details
Condition Contraception
Treatment NOMAC-E2 COC
Clinical Study IdentifierNCT05264506
SponsorOrganon and Co
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

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/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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note