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Last Updated: May 23, 2025

CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; ETONOGESTREL


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All Clinical Trials for Ethinyl Estradiol; Etonogestrel

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00369967 ↗ Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated American College of Obstetricians and Gynecologists N/A 2007-02-01 We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
NCT00369967 ↗ Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated Bayer N/A 2007-02-01 We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
NCT00369967 ↗ Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents Terminated Virginia Commonwealth University N/A 2007-02-01 We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.
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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ethinyl Estradiol; Etonogestrel

Condition Name

Condition Name for Ethinyl Estradiol; Etonogestrel
Intervention Trials
Contraception 3
Tuberculosis 1
Bioequivalence 1
Underweight 1
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Condition MeSH

Condition MeSH for Ethinyl Estradiol; Etonogestrel
Intervention Trials
Hemorrhage 1
Vaginosis, Bacterial 1
Vaginal Diseases 1
HIV Infections 1
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Clinical Trial Locations for Ethinyl Estradiol; Etonogestrel

Trials by Country

Trials by Country for Ethinyl Estradiol; Etonogestrel
Location Trials
United States 16
Peru 3
South Africa 3
Brazil 2
Thailand 2
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Trials by US State

Trials by US State for Ethinyl Estradiol; Etonogestrel
Location Trials
Colorado 2
New York 2
Virginia 2
Rhode Island 1
Ohio 1
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Clinical Trial Progress for Ethinyl Estradiol; Etonogestrel

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol; Etonogestrel
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol; Etonogestrel
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Ethinyl Estradiol; Etonogestrel

Sponsor Name

Sponsor Name for Ethinyl Estradiol; Etonogestrel
Sponsor Trials
Merck Sharp & Dohme Corp. 4
University of Colorado, Denver 1
Organon 1
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Sponsor Type

Sponsor Type for Ethinyl Estradiol; Etonogestrel
Sponsor Trials
Other 13
Industry 9
NIH 1
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Ethinyl Estradiol and Etonogestrel: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

The combination of ethinyl estradiol and etonogestrel, commonly used in vaginal rings like NuvaRing, is a widely recognized and effective contraceptive method. This article will delve into the latest clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Update

Efficacy and Safety Studies

Recent clinical trials have reaffirmed the efficacy and safety of the ethinyl estradiol and etonogestrel vaginal ring. A study aimed to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age. The study used the Pearl Index (PI) to measure efficacy, which showed a PI of 1.18 (95% confidence interval 0.73–1.80) for the ENG-E2 ring, indicating high contraceptive efficacy[1].

Another comprehensive review by the World Health Organization (WHO) highlighted that the ethinyl estradiol/etonogestrel vaginal ring demonstrated a Pearl Index of 0.77 (95% confidence interval 0.37–1.40) for women adhering to the protocol, further solidifying its effectiveness[2].

Comparative Studies

Comparative studies have been conducted to evaluate the efficacy and user satisfaction of the ethinyl estradiol/etonogestrel vaginal ring against other contraceptive methods. These studies have shown that the vaginal ring offers comparable or even superior cycle control and user satisfaction compared to combined oral contraceptives (COCs). For instance, a study found that 61% of women using the vaginal ring were very satisfied, compared to 34% using COCs[2].

Bioavailability Studies

A single-dose crossover comparative bioavailability study is currently underway to assess the bioavailability of the ethinyl estradiol/etonogestrel vaginal ring in healthy female subjects. This study aims to ensure that the generic versions, such as EluRyng by Amneal Pharmaceuticals, maintain the same bioavailability as the original NuvaRing[4].

Market Analysis

FDA Approvals and Generic Versions

In 2019, the FDA approved the first generic version of NuvaRing, EluRyng, manufactured by Amneal Pharmaceuticals. This approval marked a significant milestone in making this contraceptive method more accessible and affordable. The commercialization of EluRyng has been a key factor in expanding the market for ethinyl estradiol and etonogestrel vaginal rings[3].

Market Sales and Revenue

The market for ethinyl estradiol and etonogestrel vaginal rings has been robust. For the 12 months ending October 31, 2019, US sales for the etonogestrel/ethinyl estradiol vaginal ring were approximately $967 million. The introduction of generic versions is expected to further increase market penetration and revenue[3].

User Satisfaction and Continuation Rates

Studies have consistently shown high user satisfaction with the ethinyl estradiol/etonogestrel vaginal ring. A significant proportion of women (79%) chose to continue using the ring after the trial period, indicating high satisfaction and compliance rates. This high satisfaction level is a strong indicator of market stability and growth[2].

Market Projections

Increasing Accessibility

The approval of generic versions and the ongoing efforts to improve affordability are expected to increase the accessibility of ethinyl estradiol and etonogestrel vaginal rings. This increased accessibility will likely lead to higher adoption rates, particularly in regions where access to contraceptives is limited.

Global Health Impact

Given the high efficacy and user satisfaction of the ethinyl estradiol/etonogestrel vaginal ring, it is anticipated to play a significant role in reducing unintended pregnancies globally. The WHO has recognized the importance of this contraceptive method and is advocating for its inclusion in the Essential Medicines List, which will further boost its global reach[2].

Competitive Landscape

The contraceptive market is highly competitive, with various methods such as intrauterine devices (IUDs), injectable progestins, and oral contraceptives. However, the ease of use and minimal user intervention required for the vaginal ring are expected to maintain its competitive edge. Pharmacoeconomic analyses have shown that etonogestrel-based contraceptives, including the vaginal ring, can be cost-effective compared to other methods[5].

Adverse Events and Safety Profile

Common Adverse Events

Clinical trials have identified headache and vaginal infections/vaginal discharge as the most frequently reported undesirable effects associated with the use of the ethinyl estradiol/etonogestrel vaginal ring. However, these adverse events are generally mild and do not significantly impact the overall safety profile of the product[2].

Conclusion

The ethinyl estradiol and etonogestrel vaginal ring remains a highly effective and user-friendly contraceptive method. With ongoing clinical trials, FDA approvals of generic versions, and strong market performance, this product is poised for continued growth and increased global accessibility.

Key Takeaways

  • High Efficacy: The ethinyl estradiol/etonogestrel vaginal ring has demonstrated high contraceptive efficacy in clinical trials.
  • User Satisfaction: High user satisfaction rates and continuation rates indicate strong market stability.
  • Market Expansion: The approval of generic versions is expected to increase market penetration and revenue.
  • Global Health Impact: The product is anticipated to play a significant role in reducing unintended pregnancies globally.
  • Competitive Edge: The ease of use and minimal user intervention required maintain its competitive edge in the contraceptive market.

FAQs

What is the ethinyl estradiol/etonogestrel vaginal ring used for?

The ethinyl estradiol/etonogestrel vaginal ring is used as a contraceptive method to prevent pregnancy.

How effective is the ethinyl estradiol/etonogestrel vaginal ring?

The ring has a Pearl Index of 1.18, indicating high contraceptive efficacy, with pregnancy rates less than 1% in large efficacy trials.

What are the common adverse events associated with the ethinyl estradiol/etonogestrel vaginal ring?

Common adverse events include headache and vaginal infections/vaginal discharge.

Has the FDA approved any generic versions of the ethinyl estradiol/etonogestrel vaginal ring?

Yes, the FDA has approved the first generic version, EluRyng, manufactured by Amneal Pharmaceuticals.

How does the ethinyl estradiol/etonogestrel vaginal ring compare to other contraceptive methods?

The ring offers comparable or superior cycle control and user satisfaction compared to combined oral contraceptives and other methods, making it a competitive option in the market.

References

  1. Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol. ClinicalTrials.gov.
  2. Ethinylestradiol/Etonogestrel Vaginal Ring. World Health Organization.
  3. FDA Approves First Generic Version of NuvaRing. Pharmacy Times.
  4. Comparative Bioavailability Study of Ethinyl Estradiol/Etonogestrel Vaginal Ring. CenterWatch.
  5. CDR Pharmacoeconomic Review Report for Nexplanon. CADTH.
Last updated: 2025-01-02

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