CLINICAL TRIALS PROFILE FOR NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

All Clinical Trials for Norethindrone Acetate And Ethinyl Estradiol

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.
NCT00932321 ↗	Study of Safety and Efficacy of an Oral Contraceptive	Completed	Warner Chilcott	Phase 3	2004-01-01	This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Clinical Trial Conditions for Norethindrone Acetate And Ethinyl Estradiol

Condition Name

Condition Name for Norethindrone Acetate And Ethinyl Estradiol
Intervention	Trials
Contraception	3
Infection, Human Immunodeficiency Virus	1
Menorrhagia	1
Ovulation	1

Condition MeSH

Condition MeSH for Norethindrone Acetate And Ethinyl Estradiol
Intervention	Trials
HIV Infections	2
Endometriosis	1
Acquired Immunodeficiency Syndrome	1
Hepatitis C	1

Clinical Trial Locations for Norethindrone Acetate And Ethinyl Estradiol

Trials by Country

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

Trials by US State

Trials by US State for Norethindrone Acetate And Ethinyl Estradiol
Location	Trials
Florida	6
California	6
Washington	4
North Carolina	4
Virginia	4

Clinical Trial Progress for Norethindrone Acetate And Ethinyl Estradiol

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Norethindrone Acetate And Ethinyl Estradiol

Sponsor Name

Sponsor Name for Norethindrone Acetate And Ethinyl Estradiol
Sponsor	Trials
Warner Chilcott	3
Bristol-Myers Squibb	3
Milton S. Hershey Medical Center	1

Sponsor Type

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

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

Introduction

Norethindrone acetate and ethinyl estradiol are widely used in combination hormonal contraceptives (CHCs) and hormone replacement therapy (HRT). This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials and Efficacy

Pregnancy Prevention

Clinical trials have consistently shown that the combination of norethindrone acetate and ethinyl estradiol is highly effective in preventing pregnancy. A study using an ultra low-dose OCP regimen (1.0 mg norethindrone acetate and 10 micrograms ethinyl estradiol) demonstrated a Pearl Index of 2.2 and a cumulative pregnancy rate of 2.1, indicating strong contraceptive efficacy[3].

Bleeding Profiles

Studies comparing continuous and cyclic administration of combined oral contraceptives (OCPs) have shown that continuous administration can significantly reduce the incidence of bleeding. For instance, a trial comparing continuous LNG 90 micrograms/ethinyl estradiol 20 micrograms with cyclic LNG 100 micrograms/ethinyl estradiol 20 micrograms found that the incidence of no bleeding increased to 79% by the end of the study period in the continuous OCP group[1].

Safety and Tolerability

The safety and tolerability profile of this combination is comparable to other low-dose OCPs. A study on an extended-duration, combined hormonal OCP regimen reported that the discontinuation rate was 41.7%, primarily due to adverse events such as intracyclic bleeding, which decreased over time[3].

Adverse Effects and Side Profiles

Common Adverse Reactions

Common adverse reactions include breast tenderness (mastalgia), breast changes, and lactation suppression. Vaginal candidiasis, bacterial vaginitis, and abnormal cervical smears are also reported. Additionally, fluid retention and edema can occur, although significant increases in blood pressure are rare[4].

Specific Side Effects

Breast-related adverse reactions such as nipple pain, nipple discharge, and galactorrhea are more common in HRT users. Urogenital symptoms like vaginal infections and changes in cervical secretion are also noted[4].

Market Analysis

Global Market Overview

The global market for norethindrone acetate and ethinyl estradiol is segmented by types, applications, and regions. The market includes various formulations such as 1.0 mg/0.5 mg and 0.5 mg/0.1 mg, catering to different needs like prevention of osteoporosis and management of postmenopausal symptoms[2].

Key Players

Major players in the market include Novo Nordisk, Amneal, Lupin Pharmaceuticals, Noven Pharmaceuticals, Breckenridge Pharmaceutical, Teva, Mylan, and Accord Healthcare. These companies contribute significantly to the global and regional market share[2].

Regional Analysis

The market is analyzed across regions such as North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. The report provides detailed country-wise volume analysis and region-wise market size analysis, helping businesses target specific markets effectively[2].

Market Projections

Growth Rate and Forecast

The market is expected to grow significantly between 2020 and 2026, driven by increasing demand for hormonal contraceptives and HRT. The report provides quantitative forecasting and trends analysis, helping stakeholders understand the future landscape of the market[2].

Technological Innovations and Product Launches

The market is also influenced by technological innovations and new product launches. Companies are focusing on developing more effective and safer formulations, which is expected to drive market growth in the coming years[2].

Clinical Significance of Norethindrone Acetate Conversion

Conversion to Ethinyl Estradiol

There is ongoing research into the conversion of norethindrone acetate to ethinyl estradiol in the body. A study found that while norethindrone acetate can be converted to ethinyl estradiol, the circulating levels of ethinyl estradiol are not clinically significant[5].

Regulatory and Competitive Landscape

Trade Regulations and Competitive Analysis

The market is subject to various trade regulations and competitive dynamics. The report provides a competitive analysis for each major player, highlighting their strengths, market potential, and strategies adopted to maintain market share[2].

Conclusion

Norethindrone acetate and ethinyl estradiol remain crucial components in hormonal contraceptives and HRT, backed by robust clinical trials and a strong market presence. Understanding the efficacy, safety profile, and market dynamics is essential for both healthcare providers and industry stakeholders.

Key Takeaways

• Efficacy: The combination of norethindrone acetate and ethinyl estradiol is highly effective in preventing pregnancy and managing menstrual-related issues.
• Safety: The safety profile is comparable to other low-dose OCPs, with common adverse reactions including breast tenderness and vaginal infections.
• Market Growth: The global market is expected to grow significantly between 2020 and 2026, driven by increasing demand and technological innovations.
• Regional Analysis: The market is segmented across various regions, with detailed country-wise and region-wise analysis.
• Competitive Landscape: Major players dominate the market, with competitive strategies and product launches driving growth.

FAQs

What are the common adverse reactions associated with norethindrone acetate and ethinyl estradiol?

Common adverse reactions include breast tenderness, breast changes, lactation suppression, vaginal candidiasis, and fluid retention[4].

How effective is the combination of norethindrone acetate and ethinyl estradiol in preventing pregnancy?

The combination is highly effective, with a Pearl Index of 2.2 and a cumulative pregnancy rate of 2.1 in clinical trials[3].

What are the key regions in the global market for norethindrone acetate and ethinyl estradiol?

The key regions include North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America[2].

Which companies are major players in the norethindrone acetate and ethinyl estradiol market?

Major players include Novo Nordisk, Amneal, Lupin Pharmaceuticals, Noven Pharmaceuticals, Breckenridge Pharmaceutical, Teva, Mylan, and Accord Healthcare[2].

Is the conversion of norethindrone acetate to ethinyl estradiol clinically significant?

The conversion to ethinyl estradiol is not clinically significant based on current research[5].

Sources

1. General Approaches to Medical Management of Menstrual Suppression. ACOG.
2. Estradiol/Norethindrone Acetate drug Market Analysis. openPR.com.
3. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms. PubMed.
4. Ethinyl Estradiol; Norethindrone Acetate. Elsevier healthcare hub.
5. Formation of Ethinyl Estradiol in Women during Treatment with Norethindrone Acetate. Oxford Academic.