CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

All Clinical Trials for Ethinyl Estradiol; Norethindrone Acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000897 ↗	A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00229996 ↗	Medical Treatment of Endometriosis-Associated Pelvic Pain	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2004-07-01	The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.
NCT00338052 ↗	Study of Bleeding With Extended Administration of an Oral Contraceptive	Completed	Warner Chilcott	Phase 2	2006-06-01	This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
NCT00350480 ↗	Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial	Completed	Kaiser Permanente	N/A	2003-04-01	To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.
NCT00391807 ↗	Study of Safety and Efficacy of an Oral Contraceptive	Completed	Warner Chilcott	Phase 3	2006-11-01	This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Clinical Trial Conditions for Ethinyl Estradiol; Norethindrone Acetate

Condition Name

Condition Name for Ethinyl Estradiol; Norethindrone Acetate
Intervention	Trials
Contraception	3
Ovulation	1
PCOS	1
Arthritis	1

Condition MeSH

Condition MeSH for Ethinyl Estradiol; Norethindrone Acetate
Intervention	Trials
HIV Infections	2
Uterine Hemorrhage	1
Menorrhagia	1
Hemorrhage	1

Clinical Trial Locations for Ethinyl Estradiol; Norethindrone Acetate

Trials by Country

Trials by Country for Ethinyl Estradiol; Norethindrone Acetate
Location	Trials
United States	62

Trials by US State

Trials by US State for Ethinyl Estradiol; Norethindrone Acetate
Location	Trials
Florida	6
California	6
Virginia	4
Pennsylvania	4
Washington	4

Clinical Trial Progress for Ethinyl Estradiol; Norethindrone Acetate

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol; Norethindrone Acetate
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol; Norethindrone Acetate
Clinical Trial Phase	Trials
Completed	10
Recruiting	2
Unknown status	1

Clinical Trial Sponsors for Ethinyl Estradiol; Norethindrone Acetate

Sponsor Name

Sponsor Name for Ethinyl Estradiol; Norethindrone Acetate
Sponsor	Trials
Warner Chilcott	3
Bristol-Myers Squibb	3
Ironwood Pharmaceuticals, Inc.	1

Sponsor Type

Sponsor Type for Ethinyl Estradiol; Norethindrone Acetate
Sponsor	Trials
Industry	9
Other	7
NIH	3

Ethinyl Estradiol and Norethindrone Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Ethinyl estradiol and norethindrone acetate are two of the most commonly used hormones in oral contraceptive pills (OCPs). These hormones have been extensively studied and are integral to various contraceptive regimens. Here, we will delve into the clinical trials, market analysis, and future projections for these hormones.

Clinical Trials Overview

Bleeding Patterns and Cycle Control

Clinical trials have consistently shown that the combination of ethinyl estradiol and norethindrone acetate affects menstrual bleeding patterns. A study by the American College of Obstetricians and Gynecologists (ACOG) highlighted that continuous use of OCPs containing these hormones can significantly reduce bleeding over time. For instance, a trial comparing continuous and cyclic use of LNG 90 micrograms/ethinyl estradiol 20 micrograms showed that the incidence of no bleeding increased to 79% by the 13th pill pack in the continuous group[1].

Efficacy and Safety

The efficacy and safety of these hormones have been well-established. A clinical review for the FDA approval of norethindrone acetate 1 mg/ethinyl estradiol 10 mcg chewable tablets noted that the risk-benefit profile is favorable, with the product containing the same active hormones as previously approved formulations like Lo Loestrin Fe[2].

Extended Cycling Regimens

Extended cycling regimens, such as the 84-day dosing regimen of Seasonale, have also been studied. These regimens aim to reduce the frequency of menstrual periods. Clinical studies on Seasonale, which uses a combination of ethinyl estradiol and norethindrone, showed promising results in reducing menstrual bleeding and improving cycle control[3].

Market Analysis

Market Trends

The market for oral contraceptives is highly competitive, with a trend towards lower-dose formulations. The 2000 Contraception Survey indicated that 20-mcg ethinyl estradiol pills, such as Alesse and Mircette, were gaining popularity, challenging the dominance of higher-dose pills like Ortho Tri-Cyclen[3].

Generic and Branded Options

The market has seen an influx of generic options, such as Nortrel from Barr Laboratories, which offers lower-cost alternatives to branded products. Nortrel 1/35 and Nortrel 0.5/35 are examples of generic equivalents that compete in the $2 billion oral contraceptive market[3].

New Formulations

New formulations and delivery methods are also entering the market. For example, the chewable tablets of norethindrone acetate and ethinyl estradiol, approved under different brand names, offer convenience and potentially better compliance due to their ease of use[5].

Projections and Future Trends

Increasing Demand for Low-Dose Options

The demand for low-dose oral contraceptives is expected to continue growing. As more women seek safer and more tolerable options, formulations with lower doses of ethinyl estradiol, such as 20 mcg, are likely to gain further market share[3].

Extended Cycling Regimens

Extended cycling regimens, which reduce the frequency of menstrual periods, are anticipated to become more popular. Products like Seasonale, which offers a four-periods-per-year regimen, are expected to attract women seeking fewer menstrual cycles[3].

Generic Market Expansion

The generic market is projected to expand, offering more affordable options to consumers. Companies like Barr Laboratories are committed to building a comprehensive line of generic oral contraceptives, which will increase competition and drive down costs[3].

Adverse Effects and Management

Breakthrough Bleeding

One of the common adverse effects of continuous OCP use is breakthrough bleeding. Studies have shown that this tends to decrease in successive cycles, but patient counseling on managing breakthrough bleeding is crucial to reduce discontinuation rates[1].

Other Adverse Effects

Other potential adverse effects include venous thromboembolism (VTE) and changes in lipid profiles. However, the overall risk-benefit profile of these hormones remains favorable when used appropriately[2].

Expert Insights

Carol Cox, a spokesman for Barr Laboratories, emphasized the company's focus on providing value brands and expanding their line of generic oral contraceptives to offer women less expensive alternatives for family planning[3].

Bruce Downey, CEO of Barr Laboratories, highlighted the company's commitment to entering the $2 billion oral contraceptive market with a complete line of generic products, aiming to provide cost-effective solutions[3].

Key Takeaways

• Clinical Trials: Ethinyl estradiol and norethindrone acetate combinations have been shown to effectively reduce menstrual bleeding and improve cycle control.
• Market Trends: There is a growing demand for low-dose formulations and extended cycling regimens.
• Generic Options: The market is seeing an increase in generic options, which are expected to drive down costs and increase accessibility.
• Future Projections: The demand for low-dose and extended cycling regimens is anticipated to continue growing.
• Adverse Effects: Breakthrough bleeding is a common adverse effect, but it tends to decrease over time; patient counseling is essential.

FAQs

Q: What are the common dosages of ethinyl estradiol and norethindrone acetate in oral contraceptives?

A: Common dosages include 20 mcg of ethinyl estradiol combined with various doses of norethindrone acetate, such as 1 mg or 0.5 mg.

Q: How do extended cycling regimens affect menstrual bleeding?

A: Extended cycling regimens, like the 84-day dosing regimen of Seasonale, significantly reduce the frequency of menstrual periods and can lead to fewer bleeding episodes over time.

Q: What are the potential adverse effects of using ethinyl estradiol and norethindrone acetate?

A: Potential adverse effects include breakthrough bleeding, venous thromboembolism (VTE), and changes in lipid profiles.

Q: Are generic options available for these hormones?

A: Yes, several generic options are available, such as Nortrel from Barr Laboratories, which offer lower-cost alternatives to branded products.

Q: How do these hormones affect cycle control?

A: These hormones can improve cycle control, especially when used in continuous or extended cycling regimens, reducing the incidence of bleeding over time.

Sources

1. General Approaches to Medical Management of Menstrual Suppression - ACOG
2. Norethindrone Acetate/Ethinyl Estradiol (EE) Chewable Tablets - FDA
3. New Generic OCs Now on the Pharmacy Shelves - Relias Media
4. Relugolix, Estradiol, Norethindrone (MYFEMBREE) National Drug Monograph - VA
5. Norethindrone and Ethinyl Estradiol Chewable Tablets - FDA

Last updated: 2025-01-01