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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR ESTRADIOL VALERATE AND DIENOGEST


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All Clinical Trials for Estradiol Valerate And Dienogest

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00293059 ↗ Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding Completed Bayer Phase 3 2005-12-01 The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00307801 ↗ Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding Completed Bayer Phase 3 2006-02-01 The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00335218 ↗ Fat Distribution in Healthy Early Postmenopausal Women Completed Bayer Phase 4 2002-07-01 The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.
NCT00764881 ↗ Effects of SH T00658ID on Libido Completed Bayer Phase 3 2009-01-01 The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estradiol Valerate And Dienogest

Condition Name

Condition Name for Estradiol Valerate And Dienogest
Intervention Trials
Contraception 4
Metrorrhagia 3
Healthy 1
Libido 1
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Condition MeSH

Condition MeSH for Estradiol Valerate And Dienogest
Intervention Trials
Metrorrhagia 3
Hemorrhage 3
Uterine Hemorrhage 2
Dysmenorrhea 1
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Clinical Trial Locations for Estradiol Valerate And Dienogest

Trials by Country

Trials by Country for Estradiol Valerate And Dienogest
Location Trials
United States 20
China 20
Germany 18
Australia 11
United Kingdom 8
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Trials by US State

Trials by US State for Estradiol Valerate And Dienogest
Location Trials
Washington 1
Virginia 1
Texas 1
Tennessee 1
South Dakota 1
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Clinical Trial Progress for Estradiol Valerate And Dienogest

Clinical Trial Phase

Clinical Trial Phase for Estradiol Valerate And Dienogest
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Estradiol Valerate And Dienogest
Clinical Trial Phase Trials
Completed 13
Unknown status 1
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Clinical Trial Sponsors for Estradiol Valerate And Dienogest

Sponsor Name

Sponsor Name for Estradiol Valerate And Dienogest
Sponsor Trials
Bayer 10
Estetra 1
Adana Numune Training and Research Hospital 1
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Sponsor Type

Sponsor Type for Estradiol Valerate And Dienogest
Sponsor Trials
Industry 12
Other 4
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Estradiol Valerate and Dienogest: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Estradiol valerate and dienogest (EV/DNG) is a combination oral contraceptive (COC) that has garnered significant attention in recent years due to its unique formulation and clinical benefits. This article provides an in-depth update on the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Contraceptive Efficacy

Clinical trials have consistently demonstrated the high contraceptive efficacy of EV/DNG. Phase 3 studies conducted in North America and Europe showed that EV/DNG tablets have a Pearl Index (PI) of less than 2.0, indicating a low risk of pregnancy[5].

Bleeding Profile

The EV/DNG combination has been praised for its tolerable bleeding profile. A North American Phase III study and a European Phase III study revealed that this formulation achieves reliable contraceptive efficacy along with acceptable cycle control and low discontinuation rates over 20 treatment cycles[2][5].

Venous Thromboembolism (VTE) Risk

A pivotal study combining data from the INAS-SCORE and INAS-OC observational cohort studies indicated that EV/DNG users have a significantly lower risk of VTE compared to users of ethinyl estradiol-levonorgestrel COCs. The incidence rate of VTE events was 6.1 per 10,000 women-years for EV/DNG users, compared to 10.3 per 10,000 women-years for ethinyl estradiol-levonorgestrel users[2].

Cardiovascular Safety

The INAS-SCORE study also suggested that EV/DNG formulations exhibit trends toward lower cardiovascular risk compared to COCs containing levonorgestrel or other progestogens[2].

Metabolic Impact

Estradiol valerate has been shown to have a milder effect on metabolic parameters compared to ethinyl estradiol, making it a preferable option for women concerned about metabolic side effects[1].

Market Analysis

Approval and Availability

EV/DNG tablets, marketed under the brand name Natazia, were approved by the FDA in 2010 for the prevention of pregnancy. The drug is also approved in 27 European Union member countries and Australia[5].

Market Positioning

Natazia is positioned as a unique COC due to its multiphasic dosing regimen, which combines estradiol valerate and dienogest. This formulation addresses the need for a COC that offers both effective contraception and a favorable bleeding profile, making it an attractive option for women seeking a reliable and tolerable contraceptive method[5].

Competitive Landscape

The COC market is highly competitive, with numerous formulations available. However, the EV/DNG combination stands out due to its lower VTE risk and improved bleeding profile compared to traditional ethinyl estradiol-based COCs. This differentiation is likely to drive market share and patient preference[2].

Market Projections

Growth Potential

Given its unique benefits, EV/DNG is expected to see significant growth in the contraceptive market. The global contraceptive market is projected to expand, driven by increasing awareness and demand for safe and effective contraceptive methods. EV/DNG is well-positioned to capture a substantial share of this growing market[2].

Target Market

The primary target market for EV/DNG includes women of reproductive age seeking a reliable and tolerable contraceptive method. This includes women who have experienced adverse effects from traditional COCs, such as heavy menstrual bleeding or increased VTE risk. The drug's favorable profile is likely to attract a significant number of these women, contributing to its market growth[1][5].

Regulatory Environment

The regulatory environment is supportive, with approvals in multiple regions. Ongoing surveillance and post-marketing studies will continue to provide data on the safety and efficacy of EV/DNG, further solidifying its market position[2][5].

Key Takeaways

  • High Contraceptive Efficacy: EV/DNG has demonstrated robust contraceptive efficacy with a Pearl Index of less than 2.0.
  • Favorable Bleeding Profile: The drug offers a tolerable bleeding profile with lower rates of unscheduled bleeding and higher rates of amenorrhea.
  • Lower VTE Risk: EV/DNG users have a significantly lower risk of VTE compared to users of ethinyl estradiol-levonorgestrel COCs.
  • Cardiovascular Safety: The formulation exhibits trends toward lower cardiovascular risk.
  • Market Growth Potential: EV/DNG is expected to see significant growth in the contraceptive market due to its unique benefits and favorable profile.

FAQs

What is the primary indication for Estradiol Valerate and Dienogest?

The primary indication for EV/DNG is the prevention of pregnancy in women of reproductive age[5].

How does the bleeding profile of EV/DNG compare to other COCs?

EV/DNG has a more favorable bleeding profile, with lower rates of unscheduled bleeding and higher rates of amenorrhea compared to traditional COCs[1][2].

What is the VTE risk associated with EV/DNG?

EV/DNG users have a significantly lower risk of VTE compared to users of ethinyl estradiol-levonorgestrel COCs, with an incidence rate of 6.1 VTE events per 10,000 women-years[2].

Is EV/DNG approved in multiple regions?

Yes, EV/DNG is approved in the U.S., 27 European Union member countries, and Australia[5].

What are the metabolic effects of EV/DNG compared to ethinyl estradiol-based COCs?

EV/DNG has a milder effect on metabolic parameters compared to ethinyl estradiol-based COCs, making it a preferable option for women concerned about metabolic side effects[1].

Sources

  1. Update on current contraceptive options: A case-based discussion. CCJM, 2023.
  2. Estradiol Valerate-Dienogest and VTE Risk in Combined Oral Contraceptives. Relias Media, 2024.
  3. Pharmacology, clinical | Study 13469 | Bayer - Clinical Trials Explorer. Bayer.
  4. N22252 Natazia Clinical PREA - FDA. FDA.
  5. 22-252 Original-1 - accessdata.fda.gov. FDA.

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