CLINICAL TRIALS PROFILE FOR NORETHINDRONE AND ETHINYL ESTRADIOL

All Clinical Trials for Norethindrone 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.
NCT00004763 ↗	Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism	Completed	Baylor College of Medicine	Phase 2	1993-01-01	OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
NCT00004763 ↗	Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism	Completed	National Center for Research Resources (NCRR)	Phase 2	1993-01-01	OBJECTIVES: I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	University of Alabama at Birmingham	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.
NCT00006133 ↗	Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus	Completed	National Center for Research Resources (NCRR)	N/A	2000-06-01	OBJECTIVES: I. Determine the effect of oral contraceptives containing low-dose synthetic estrogens and progestins on disease activity in premenopausal women with inactive, stable, or moderate systemic lupus erythematosus (SLE). II. Determine the effect of hormone replacement therapy with conjugated estrogens and progestins on disease activity in postmenopausal women with inactive, stable, or moderate SLE.

Clinical Trial Conditions for Norethindrone And Ethinyl Estradiol

Condition Name

Condition Name for Norethindrone And Ethinyl Estradiol
Intervention	Trials
Contraception	4
Healthy	3
Healthy Participants	3
Dysmenorrhea	3

Condition MeSH

Condition MeSH for Norethindrone And Ethinyl Estradiol
Intervention	Trials
HIV Infections	3
Dysmenorrhea	3
Lupus Erythematosus, Systemic	2
Arthritis	2

Clinical Trial Locations for Norethindrone And Ethinyl Estradiol

Trials by Country

Trials by Country for Norethindrone And Ethinyl Estradiol
Location	Trials
United States	112
Netherlands	1
Belgium	1
United Kingdom	1
Denmark	1

Trials by US State

Trials by US State for Norethindrone And Ethinyl Estradiol
Location	Trials
California	12
Florida	10
Texas	8
North Carolina	6
Virginia	6

Clinical Trial Progress for Norethindrone And Ethinyl Estradiol

Clinical Trial Phase

Clinical Trial Phase for Norethindrone And Ethinyl Estradiol
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	10
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Norethindrone And Ethinyl Estradiol
Clinical Trial Phase	Trials
Completed	29
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Norethindrone And Ethinyl Estradiol

Sponsor Name

Sponsor Name for Norethindrone And Ethinyl Estradiol
Sponsor	Trials
Bristol-Myers Squibb	9
GlaxoSmithKline	4
Warner Chilcott	4

Sponsor Type

Sponsor Type for Norethindrone And Ethinyl Estradiol
Sponsor	Trials
Industry	36
Other	19
NIH	5

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

Introduction

Norethindrone acetate and ethinyl estradiol are synthetic hormones commonly used in combination for oral contraceptives 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 demonstrated the efficacy of norethindrone acetate and ethinyl estradiol in preventing pregnancy. A study using an ultra low-dose regimen of 1.0 mg norethindrone acetate and 10 micrograms ethinyl estradiol showed a Pearl Index of 2.2 and a cumulative pregnancy rate of 2.1, indicating high effectiveness in pregnancy prevention[3].

Safety and Tolerability

The same study highlighted that this ultra low-dose regimen has a safety and tolerability profile comparable to other low-dose oral contraceptive pills (OCPs). Participants experienced an average of 2.6 days of intracyclic bleeding or spotting per cycle, which decreased after the second cycle[3].

Adverse Reactions

Common adverse reactions reported during clinical trials include vaginal candidiasis, bacterial vaginitis, and abnormal cervical smears. Headaches, including migraines, are also frequently reported, and in some cases, these can be prodromal of cerebrovascular events[1].

Pharmacokinetics and Metabolism

Absorption and Distribution

Norethindrone acetate and ethinyl estradiol have an absolute bioavailability of approximately 64% and 43%, respectively. Both steroids have extensive plasma protein binding, with norethindrone binding to albumin and sex hormone-binding globulin, and ethinyl estradiol binding only to albumin[4].

Metabolism

Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. A small amount of norethindrone acetate is metabolically converted to ethinyl estradiol. Ethinyl estradiol is also extensively metabolized by oxidation and conjugation with sulfate and glucuronide[4].

Market Analysis

Current Market Size

The market for estradiol and norethindrone acetate was valued at USD 2 billion in 2023. This market is expected to grow significantly, reaching USD 3.6 billion by the end of 2030, with a compound annual growth rate (CAGR) of 8% during the forecast period[2].

Market Drivers

The growth in this market is driven by several factors, including the increasing need for menopausal symptom management products as the global population ages. Improvements in drug formulation, changing healthcare trends, and strategic alliances within the pharmaceutical sector also contribute to market dynamics[2].

Competitive Landscape

Key players in the estradiol and norethindrone acetate market include Novo Nordisk, Amneal, Lupin Pharmaceuticals, Noven Pharmaceuticals, Breckenridge Pharmaceutical, Teva, Mylan, and Accord Healthcare. These companies invest heavily in research and development to improve the efficacy and safety profiles of their products[2].

Future Projections

Emerging Trends

The market is undergoing a dynamic transformation driven by emerging trends in women's healthcare. There is a rising awareness and emphasis on individualized treatment, technological advancements, and the development of non-oral alternatives such as transdermal patches, vaginal rings, and injectables. These alternatives offer better adherence, less exposure to hormones, and potentially fewer adverse effects, especially for high-risk patients[2].

Regulatory Environment

Changes in the regulatory environment also impact market dynamics. Pharmaceutical companies must adhere to strict production criteria, conduct thorough clinical trials, and comply with regulatory requirements to ensure their products meet the highest quality standards[2].

Quality and Safety

Production Criteria

To maintain high quality and safety, pharmaceutical companies follow strict production criteria. This includes conducting thorough clinical trials and adhering to regulatory requirements. The focus is on improving the efficacy and safety profiles of the products to ensure they meet the highest standards before distribution[2].

Adverse Events

Despite the overall safety profile, postmarketing reports have included various adverse events such as urogenital infections, visual impairments, and changes in blood pressure. It is crucial to monitor these effects and discontinue the treatment if significant adverse reactions occur[1].

Key Takeaways

• Efficacy: Norethindrone acetate and ethinyl estradiol are highly effective in preventing pregnancy and managing menopausal symptoms.
• Safety and Tolerability: The combination has a comparable safety and tolerability profile to other low-dose OCPs, though it can cause various adverse reactions.
• Market Growth: The market is expected to grow from USD 2 billion in 2023 to USD 3.6 billion by 2030, driven by aging populations and advancements in healthcare.
• Competitive Landscape: Major pharmaceutical companies are investing in research and development to improve product quality and safety.
• Emerging Trends: Non-oral alternatives and individualized treatments are gaining traction, offering better adherence and potentially fewer side effects.

FAQs

What are the common uses of norethindrone acetate and ethinyl estradiol?

Norethindrone acetate and ethinyl estradiol are commonly used as oral combined hormonal contraceptives (CHCs) and for hormone replacement therapy (HRT) to manage menopausal symptoms.

What are the potential side effects of this drug combination?

Common side effects include vaginal candidiasis, bacterial vaginitis, headaches, migraines, and changes in blood pressure. Visual impairments and urogenital infections have also been reported postmarketing.

How effective is this combination in preventing pregnancy?

Clinical trials have shown that the combination of norethindrone acetate and ethinyl estradiol is highly effective in preventing pregnancy, with a Pearl Index of 2.2 and a cumulative pregnancy rate of 2.1.

What is the expected market growth for this drug combination?

The market is expected to grow from USD 2 billion in 2023 to USD 3.6 billion by 2030, with a CAGR of 8%.

Who are the key players in the estradiol and norethindrone acetate market?

Key players include Novo Nordisk, Amneal, Lupin Pharmaceuticals, Noven Pharmaceuticals, Breckenridge Pharmaceutical, Teva, Mylan, and Accord Healthcare.

Sources

1. Ethinyl Estradiol; Norethindrone Acetate - Elsevier healthcare hub
2. Estradiol/Norethindrone Acetate drug Market Size, Share and ... - Verified Market Reports
3. Norethindrone acetate 1.0 milligram and ethinyl estradiol ... - PubMed
4. LOESTRIN® 21 (Norethindrone Acetate and Ethinyl Estradiol ... - FDA
5. Formation of Ethinyl Estradiol in Women during Treatment with ... - Oxford Academic