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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR DESOGESTREL; ETHINYL ESTRADIOL


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All Clinical Trials for DESOGESTREL; ETHINYL ESTRADIOL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00612508 ↗ Hormonal Contraception and Vaginal Health Completed Oregon Clinical and Translational Research Institute N/A 2007-05-01 The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
NCT00612508 ↗ Hormonal Contraception and Vaginal Health Completed Oregon Health and Science University N/A 2007-05-01 The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
NCT00439972 ↗ Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity Unknown status Ortho-McNeil Pharmaceutical Phase 2 2007-02-01 The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
NCT00439972 ↗ Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity Unknown status University of Washington Phase 2 2007-02-01 The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
NCT00204438 ↗ Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle Completed Canadian Institutes of Health Research (CIHR) N/A 2002-02-01 We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.
NCT00204438 ↗ Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle Completed University of Saskatchewan N/A 2002-02-01 We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for DESOGESTREL; ETHINYL ESTRADIOL

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2ContraceptionBioequivalenceContraceptive UsagePCOS[disabled in preview]
Condition Name for DESOGESTREL; ETHINYL ESTRADIOL
Intervention Trials
Contraception 2
Bioequivalence 1
Contraceptive Usage 1
PCOS 1
[disabled in preview] 0
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Acne Vulgaris[disabled in preview]
Condition MeSH for DESOGESTREL; ETHINYL ESTRADIOL
Intervention Trials
Acne Vulgaris 1
[disabled in preview] 0
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Clinical Trial Locations for DESOGESTREL; ETHINYL ESTRADIOL

Trials by Country

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Trials by Country for DESOGESTREL; ETHINYL ESTRADIOL
Location Trials
United States 3
Chile 1
Canada 1
Thailand 1
Iran, Islamic Republic of 1
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Trials by US State

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Trials by US State for DESOGESTREL; ETHINYL ESTRADIOL
Location Trials
Pennsylvania 1
Oregon 1
Washington 1
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Clinical Trial Progress for DESOGESTREL; ETHINYL ESTRADIOL

Clinical Trial Phase

14.3%14.3%28.6%42.9%00.811.21.41.61.822.22.42.62.833.2Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for DESOGESTREL; ETHINYL ESTRADIOL
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 2
[disabled in preview] 3
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Clinical Trial Status

57.1%28.6%14.3%000.511.522.533.54CompletedUnknown statusRecruiting[disabled in preview]
Clinical Trial Status for DESOGESTREL; ETHINYL ESTRADIOL
Clinical Trial Phase Trials
Completed 4
Unknown status 2
Recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for DESOGESTREL; ETHINYL ESTRADIOL

Sponsor Name

trials0112233National Institutes of Health (NIH)Anuja DokrasCanadian Institutes of Health Research (CIHR)[disabled in preview]
Sponsor Name for DESOGESTREL; ETHINYL ESTRADIOL
Sponsor Trials
National Institutes of Health (NIH) 1
Anuja Dokras 1
Canadian Institutes of Health Research (CIHR) 1
[disabled in preview] 3
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Sponsor Type

69.2%23.1%7.7%00123456789OtherIndustryNIH[disabled in preview]
Sponsor Type for DESOGESTREL; ETHINYL ESTRADIOL
Sponsor Trials
Other 9
Industry 3
NIH 1
[disabled in preview] 0
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DESOGESTREL; ETHINYL ESTRADIOL Market Analysis and Financial Projection

Desogestrel and Ethinyl Estradiol: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Desogestrel and ethinyl estradiol are components of a widely used combined hormonal contraceptive (CHC) that has been a staple in reproductive health for decades. This article delves into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Monophasic Oral Contraceptive Trials

A significant clinical trial involving 1,613 women across 47 centers in 11 countries evaluated the efficacy and acceptability of a monophasic oral contraceptive containing 30 micrograms of ethinyl estradiol and 150 micrograms of desogestrel. The trial, which spanned 23,258 menstrual cycles, showed excellent cycle control, with a low incidence of irregular bleeding and no pregnancies attributable to method failure. The combination, known as Marvelon, demonstrated reliability and acceptability, with minor side effects decreasing over subsequent cycles[3].

Cycle Control and Side Effects

The trial highlighted that the ethinyl estradiol-desogestrel combination had no effect on average blood pressure and did not significantly impact body weight for most participants. However, women under 20 years of age were more likely to experience weight gain. The discontinuation rate due to bleeding problems was only 6% after 24 cycles, and the rate for minor side effects was 4% during the same period[3].

Additional Clinical Findings

Desogestrel, as a third-generation progestin, has unique advantages, including minimal androgenic effects and no counteraction of the ethinyl estradiol-induced increase in high-density lipoprotein (HDL). This makes it beneficial for patients with concerns about acne, fluid retention, and lipid profiles[1][5].

Market Analysis

Current Market Size and Segmentation

The Desogestrel and Ethinyl Estradiol Tablets Market has experienced rapid growth in recent years. As of 2023, the market size is valued in billions of USD, with projections indicating continued significant expansion until 2031. The market is segmented by type (short-acting and long-acting contraceptives) and application (hospital, clinic), as well as by geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Market Dynamics and Trends

The market analysis reveals a blend of drivers, restraints, opportunities, and challenges. Key drivers include increasing demand for effective and reliable contraceptive methods, especially among younger populations. However, restraints such as potential side effects and contraindications in certain medical conditions also play a significant role. The report highlights opportunities for growth in emerging markets and the impact of economic, political, and social landscapes on the market[2].

Competitive Landscape

The Desogestrel and Ethinyl Estradiol Tablets Market report profiles prominent companies involved in the production and distribution of these tablets. It includes information on the year of market entry for each player, providing valuable insights for research and analysis. The competitive landscape is characterized by both established and emerging players, each contributing to the market's dynamic growth[2].

Projections and Future Outlook

Market Growth Projections

The market is anticipated to continue its upward trend from 2023 to 2031, driven by increasing demand and advancements in contraceptive technology. The report forecasts robust growth rates, indicating a significant expansion in the market size during the forecasted period[2].

Emerging Trends and Opportunities

Emerging trends include the development of products with reduced hormone-free intervals, which can be advantageous for patients experiencing migraines, dysmenorrhea, or other symptoms during the hormone-free days. Additionally, the focus on improving the safety profile and reducing the risk of thromboembolism will be crucial for future market growth[1][2].

Regulatory and Safety Considerations

Regulatory bodies continue to emphasize the importance of safety, particularly regarding the risk of venous and arterial thromboembolism. The FDA and other health authorities have boxed warnings regarding these risks, especially for tobacco smokers. Practitioners must carefully consider these risks when selecting a CHC for their patients[1][4].

Key Takeaways

  • Clinical Efficacy: Desogestrel and ethinyl estradiol combinations have shown high efficacy in preventing pregnancy with excellent cycle control and minimal side effects.
  • Market Growth: The market is expected to expand significantly from 2023 to 2031, driven by increasing demand and technological advancements.
  • Safety Considerations: The risk of thromboembolism and other side effects necessitates careful patient selection and monitoring.
  • Emerging Trends: Products with reduced hormone-free intervals and improved safety profiles are likely to shape the future market.

FAQs

Q: What are the primary components of desogestrel and ethinyl estradiol tablets?

A: Desogestrel and ethinyl estradiol tablets contain a combination of desogestrel, a third-generation progestin, and ethinyl estradiol, a synthetic estrogen[1][4].

Q: How effective is the desogestrel and ethinyl estradiol combination in preventing pregnancy?

A: The combination is highly effective, with only one pregnancy reported in a clinical trial involving 23,258 menstrual cycles, and this was due to patient failure rather than method failure[3].

Q: What are the common side effects of desogestrel and ethinyl estradiol tablets?

A: Common side effects include nausea, headache, nervousness, and breast tension, although these decrease over subsequent cycles. Weight gain is more common in women under 20 years of age[3].

Q: Can desogestrel and ethinyl estradiol tablets be used by women of all ages?

A: These tablets are not indicated for use in women before menarche or in elderly women. They are suitable for women from menarche to menopause, provided there are no contraindications[1][4].

Q: How do desogestrel and ethinyl estradiol tablets affect blood pressure and lipid profiles?

A: The combination does not affect average blood pressure and may have positive influences on lipid profiles due to desogestrel's minimal androgenic effects[1][3].

Sources

  1. Elsevier Health: Desogestrel; Ethinyl Estradiol - Elsevier healthcare hub.
  2. Market Research Intellect: Desogestrel and Ethinyl Estradiol Tablets Market Size, Scope And ...
  3. PubMed: Multicenter trial of a monophasic oral contraceptive containing ...
  4. Mayo Clinic: Desogestrel and ethinyl estradiol (oral route) - Mayo Clinic.
  5. FDA: MIRCETTE® (desogestrel/ethinyl estradiol and ... - accessdata.fda.gov.

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