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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL


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All Clinical Trials for 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.
NCT00001221 ↗ Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1987-09-01 Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries. In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period. This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups. 1. Group one will receive low dose estrogen 2. Group two will receive growth hormone 3. Group three will receive both low dose estrogen and growth hormone 4. Group four will receive a placebo "sugar pill" Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16. Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ethinyl Estradiol

Condition Name

Condition Name for Ethinyl Estradiol
Intervention Trials
Contraception 56
Healthy 25
Female Contraception 11
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Condition MeSH

Condition MeSH for Ethinyl Estradiol
Intervention Trials
HIV Infections 11
Syndrome 8
Dysmenorrhea 8
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Clinical Trial Locations for Ethinyl Estradiol

Trials by Country

Trials by Country for Ethinyl Estradiol
Location Trials
United States 461
China 33
Germany 27
Canada 18
Mexico 11
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Trials by US State

Trials by US State for Ethinyl Estradiol
Location Trials
California 34
Florida 32
Texas 27
Pennsylvania 24
Arizona 20
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Clinical Trial Progress for Ethinyl Estradiol

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol
Clinical Trial Phase Trials
Phase 4 35
Phase 3 59
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol
Clinical Trial Phase Trials
Completed 161
Recruiting 17
Unknown status 15
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Clinical Trial Sponsors for Ethinyl Estradiol

Sponsor Name

Sponsor Name for Ethinyl Estradiol
Sponsor Trials
Bayer 20
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 17
Bristol-Myers Squibb 15
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Sponsor Type

Sponsor Type for Ethinyl Estradiol
Sponsor Trials
Industry 181
Other 102
NIH 13
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Ethinyl Estradiol: Clinical Trials, Market Analysis, and Projections

Introduction to Ethinyl Estradiol

Ethinyl estradiol is a synthetic form of estrogen widely used in combined oral contraceptives (COCs) to prevent pregnancy. It is often combined with progestins like levonorgestrel to enhance its contraceptive efficacy.

Clinical Trials Update

Current Studies

One notable clinical trial involving ethinyl estradiol is the study conducted by AstraZeneca to assess the pharmacokinetics of ethinyl estradiol and levonorgestrel when administered with baxdrostat. This open-label, fixed-sequence study involves healthy female participants of non-childbearing potential and aims to evaluate the effect of multiple doses of baxdrostat on the pharmacokinetics of a single dose of combined oral ethinyl estradiol and levonorgestrel[1].

  • Study Design: The study is divided into three periods. In the first period, participants receive a single oral dose of ethinyl estradiol and levonorgestrel (EE/LNG) followed by pharmacokinetic (PK) sampling. In the second period, participants self-administer baxdrostat once daily for 11 days. In the third period, participants receive baxdrostat once daily and a single dose of EE/LNG, followed by PK sampling.
  • Participant Profile: The study includes 48 healthy female participants aged between 35 and 75 years.
  • Primary Purpose: The primary purpose is to assess the pharmacokinetic interactions between baxdrostat and EE/LNG.

Market Analysis

Market Size and Growth

The combined oral contraceptive market, which includes ethinyl estradiol, is projected to experience significant growth from 2025 to 2033. This growth is driven by increasing demand for contraception, particularly among women participating in the workforce. The market size for ethinyl estradiol and levonorgestrel is expected to reach substantial figures by 2033, with a compound annual growth rate (CAGR) of several percent[2].

Key Market Drivers

  • Growing Demand for Birth Control: Increasing awareness and access to contraceptives are major drivers of the market.
  • Rising Preference for Oral Contraceptives: The convenience and effectiveness of oral contraceptives contribute to their popularity.
  • Emerging Market Expansion: There is significant untapped potential in developing countries, which is expected to drive market growth.
  • Government Support: Funding for family planning initiatives and educational campaigns also boost the market[2].

Regulatory Environment

Ethinyl estradiol and levonorgestrel are subject to strict regulatory approvals from bodies such as the US FDA, EMA, and WHO. These organizations enforce safety and efficacy guidelines, including regular health check-ups and monitoring of contraceptive use[2].

Product Substitutes

While ethinyl estradiol and levonorgestrel are widely used, other contraceptive methods such as intrauterine devices (IUDs) and subdermal implants are gaining traction due to their long-term, reversible nature[2].

Market Segmentation

Application and Types

The market for ethinyl estradiol and levonorgestrel is segmented based on application and types of contraceptives.

  • Application: The primary application is for birth control among women of reproductive age.
  • Types: Oral contraceptives dominate the market due to their ease of use and accessibility[2].

Geographic Concentration

North America holds the largest market share, driven by high contraceptive use rates. Other significant regions include Europe and Asia-Pacific[2].

Emerging Trends

Personalized Contraception

There is a growing trend towards personalized contraceptive regimens, adapting to individual needs and health profiles.

Telemedicine and Digital Health

The use of telemedicine and digital health platforms is enhancing access to contraception, making it more convenient for users to obtain and manage their contraceptive care[2].

Research in Side Effect Mitigation

Efforts are being made to develop formulations that minimize adverse effects associated with ethinyl estradiol and levonorgestrel, such as blood clots and nausea[5].

Challenges and Restraints

Safety Concerns

Potential side effects, including blood clots and nausea, are significant concerns that can impact market growth.

Access Barriers

Limited availability in some regions, particularly in rural areas, and cultural or religious resistance to contraception also pose challenges[2].

Recent Approvals and Innovations

FDA Approvals

Recently, the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet for the prevention of pregnancy. This innovation highlights the ongoing development of more convenient and effective contraceptive options[3].

New Delivery Methods

The approval of NEXTSTELLIS (drospirenone and estetrol) by the FDA in 2021 marked a significant development, as it introduced a new estrogen (estetrol) derived from a plant source, offering potential advantages over other estrogens[5].

Growth Catalysts

Increasing Contraceptive Awareness

Educational campaigns and improved healthcare access are increasing awareness and use of contraceptives.

Development of New Delivery Methods

Long-acting contraceptives and implants are becoming more popular, offering alternatives to traditional oral contraceptives.

Government Support

Funding for family planning initiatives and regulatory support are crucial in driving the growth of the contraceptive market[2].

Key Takeaways

  • Ethinyl estradiol is a critical component of combined oral contraceptives, with ongoing clinical trials assessing its pharmacokinetics.
  • The market for ethinyl estradiol and levonorgestrel is projected to grow significantly due to increasing demand and emerging market expansion.
  • Regulatory approvals and safety guidelines are stringent, ensuring the efficacy and safety of these contraceptives.
  • Emerging trends include personalized contraception, telemedicine, and research into minimizing side effects.
  • Despite challenges such as safety concerns and access barriers, the market is driven by growing awareness, new delivery methods, and government support.

FAQs

What is the primary purpose of the clinical trial involving ethinyl estradiol and baxdrostat?

The primary purpose is to assess the pharmacokinetic interactions between baxdrostat and ethinyl estradiol and levonorgestrel in healthy female participants.

Which regions dominate the market for ethinyl estradiol and levonorgestrel?

North America holds the largest market share, followed by Europe and Asia-Pacific.

What are some emerging trends in the use of ethinyl estradiol and levonorgestrel?

Emerging trends include personalized contraception, the use of telemedicine and digital health platforms, and research into minimizing adverse effects.

What are some challenges facing the market for ethinyl estradiol and levonorgestrel?

Challenges include safety concerns, access barriers, and cultural or religious resistance to contraception.

What recent innovations have been approved for contraceptive use?

Recent innovations include the FDA approval of Femlyv (norethindrone acetate and ethinyl estradiol) and NEXTSTELLIS (drospirenone and estetrol).

Sources

  1. AstraZeneca Clinical Trials: "A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-childbearing Potential."
  2. Data Insights Market: "Ethinyl Estradiol and Levonorgestrel - Data Insights Market."
  3. FDA News: "FDA Roundup: July 23, 2024."
  4. Mayo Clinic: "Desogestrel and ethinyl estradiol (oral route) - Mayo Clinic."
  5. Mordor Intelligence: "Contraceptive Pills Market Size & Share Analysis - Mordor Intelligence."

More… ↓

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