What side effects are associated with this type of intervention?

Common side effects of combined hormonal contraceptives, such as those containing Nomegestrol Acetate and Estradiol, include nausea, breast tenderness, headaches, and mood changes. Some women may experience breakthrough bleeding or spotting, particularly in the initial cycles of use. Other potential side effects can include weight gain, changes in libido, and an increased risk of blood clots. Most women tolerate these contraceptives well, but it is important to discuss any concerns with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several combined oral contraceptives for birth control that function similarly to NOMAC-E2 by inhibiting ovulation, altering cervical mucus, and changing the endometrial lining. Notable examples include ethinylestradiol combined with various progestins such as drospirenone (Yaz, Yasmin), norgestimate (Ortho Tri-Cyclen), and levonorgestrel (Seasonique). These contraceptives have been widely used and studied, demonstrating efficacy in preventing pregnancy and managing conditions like acne and endometriosis.

What other types of research exist?

Promising novel alternatives to NOMAC-E2 for birth control in 2024 include: 1) Drospirenone and Ethinyl Estradiol oral contraceptives, which have shown efficacy in acne treatment and contraceptive use. 2) Segesterone Acetate and Ethinyl Estradiol vaginal ring (Annovera), which offers a year-long contraceptive option. 3) Etonogestrel/Ethinyl Estradiol vaginal ring (NuvaRing), which has shown similar efficacy in both obese and normal-weight women. 4) Levonorgestrel-releasing intrauterine system (LNG-IUS), which provides long-term contraception with a favorable safety profile. 5) Non-hormonal options like the Copper IUD, which is effective and hormone-free.

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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

Must not have

Less than 2 normal menstrual cycles following recent pregnancy of gestational age

Known HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Summary

This trial tests a birth control pill with two hormones in sexually active women aged 14-35. The pill works by stopping egg release, blocking sperm, and preventing egg attachment.

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.

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.

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 below

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I am a woman aged 14-35 and have started menstruating but have not reached menopause.

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I do not plan to become pregnant in the next year and won't use other birth control methods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had fewer than 2 menstrual cycles since my recent pregnancy.

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I am HIV positive.

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I have not been treated for gonorrhea, chlamydia, or trichomonas.

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I have had vaginal bleeding that hasn't been explained or resolved.

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I have a history of blood clots or heart-related issues.

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My high blood pressure is severe or not under control.

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I have very high or very low blood fat levels.

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I have had migraines with visual disturbances or specific neurological symptoms.

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I have diabetes with complications or it has lasted more than 20 years.

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I have had pancreatitis due to very high triglyceride levels.

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I have or had a serious liver condition.

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I have had surgery that affects how my body absorbs food.

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I have had cancer within the last 5 years.

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I have or had a meningioma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

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

+6 more

Awards & Highlights

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.

Trial 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.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common birth control treatments, such as those containing Nomegestrol Acetate and Estradiol, work through several mechanisms. Firstly, they inhibit ovulation by suppressing the release of gonadotropins, which prevents the ovaries from releasing an egg. Secondly, they alter the cervical mucus, making it thicker and more difficult for sperm to penetrate. Lastly, they change the endometrial lining, making it less suitable for implantation of a fertilized egg. These mechanisms are crucial for birth control patients as they provide a multi-faceted approach to preventing pregnancy, thereby increasing the efficacy and reliability of the contraceptive method.

A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17β-estradiol in the treatment of women with primary dysmenorrhea.Not all progestins are the same: implications for usage.