You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR ESTRACE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Estrace

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00114517 ↗ ELITE: Early Versus Late Intervention Trial With Estradiol Completed National Institute on Aging (NIA) Phase 2/Phase 3 2004-07-01 The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.
NCT00114517 ↗ ELITE: Early Versus Late Intervention Trial With Estradiol Completed University of Southern California Phase 2/Phase 3 2004-07-01 The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.
NCT00115024 ↗ EPAT: Estrogen in the Prevention of Atherosclerosis Trial Completed Mead Johnson Nutrition Phase 2/Phase 3 1994-04-01 The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
NCT00115024 ↗ EPAT: Estrogen in the Prevention of Atherosclerosis Trial Completed National Institute on Aging (NIA) Phase 2/Phase 3 1994-04-01 The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
NCT00465894 ↗ Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms Completed Pfizer N/A 2007-04-01 The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
NCT00465894 ↗ Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms Completed University of Alabama at Birmingham N/A 2007-04-01 The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
NCT00661531 ↗ Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy Terminated Georgetown University Phase 2 2008-04-01 This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Estrace

Condition Name

Condition Name for Estrace
Intervention Trials
Atrophic Vaginitis 3
Menopause 2
Atherosclerosis 2
Metastatic Breast Cancer 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Estrace
Intervention Trials
Atrophy 7
Breast Neoplasms 4
Vaginitis 4
Polycystic Ovary Syndrome 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Estrace

Trials by Country

Trials by Country for Estrace
Location Trials
United States 113
Canada 1
Chile 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Estrace
Location Trials
California 8
Florida 7
Pennsylvania 7
Virginia 6
North Carolina 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Estrace

Clinical Trial Phase

Clinical Trial Phase for Estrace
Clinical Trial Phase Trials
Phase 4 6
Phase 3 9
Phase 2/Phase 3 2
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Estrace
Clinical Trial Phase Trials
Completed 17
Not yet recruiting 7
Recruiting 5
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Estrace

Sponsor Name

Sponsor Name for Estrace
Sponsor Trials
National Institute of Mental Health (NIMH) 3
University of North Carolina, Chapel Hill 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 3
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Estrace
Sponsor Trials
Other 36
Industry 15
NIH 10
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for Estrace (Estradiol)

Introduction to Estrace (Estradiol)

Estrace, commonly known as estradiol, is a form of estrogen used in hormone replacement therapy (HRT) to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and mood swings. Here, we will delve into recent clinical trials, market analysis, and future projections for estradiol.

Clinical Trials and Evidence

Breast Cancer Incidence

Recent clinical trials have provided significant insights into the effects of estrogen-alone therapy on breast cancer incidence. A meta-analysis of randomized clinical trials found that estrogen-alone use significantly reduces breast cancer incidence. The study, which included 14,282 participants and 591 incident breast cancers, showed a relative risk (RR) of 0.77 (95% CI 0.65-0.91, P = 0.002) when comparing estrogen-alone to placebo groups[1].

Cardiovascular Health

Other studies have examined the impact of estrogen on cardiovascular health. For instance, the Women's Health Initiative (WHI) and the Heart and Estrogen/Progestin Replacement Study (HERS) have investigated the effects of estrogen plus progestin and estrogen-alone on coronary heart disease (CHD). While these studies have shown mixed results, they highlight the importance of careful patient selection and monitoring in HRT[4].

Market Analysis

Current Market Size and Growth

The global hormone replacement therapy (HRT) market, which includes estradiol, is substantial and growing. In 2024, the HRT market was valued at USD 37.40 billion and is expected to grow to USD 39.64 billion in 2025. By 2034, the market is projected to reach USD 66.98 billion, with a compound annual growth rate (CAGR) of 6% from 2025 to 2034[2].

Estradiol Gel Market

Specifically, the global estradiol gel market was valued at US$ 79 million in 2023 and is anticipated to reach US$ 127 million by 2030, with a CAGR of 7.3% during the forecast period. This growth is driven by the increasing incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[5].

Regional Market Dynamics

The market for estradiol gel is well-established in North America and Europe, where menopausal health is a significant healthcare concern. The Asia-Pacific region also offers promising growth opportunities due to its rapidly aging population and improving healthcare infrastructure[5].

Market Projections

Increasing Demand

The demand for estradiol and other HRT products is expected to increase due to several factors:

  • Aging Population: The global population is aging, leading to a higher incidence of menopausal symptoms.
  • Awareness and Acceptance: Growing awareness and acceptance of menopausal health issues are driving the demand for HRT.
  • Improving Healthcare Infrastructure: Enhancements in healthcare infrastructure, especially in regions like the Asia-Pacific, will facilitate greater access to HRT products[5].

Competitive Landscape

The estradiol gel market is competitive, with key players including Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, and Wuhan Jianmin Group. These companies are investing in research and development to improve product efficacy and patient compliance[5].

Emerging Trends and Therapies

Selective Estrogen Receptor Degraders (SERDs)

While estradiol remains a cornerstone in HRT, other therapies like Selective Estrogen Receptor Degraders (SERDs) are gaining traction. SERDs, such as Faslodex and ORSERDU, are being used in the treatment of breast cancer and are expected to transform the market landscape with their potential in both metastatic and early-stage HR+/HER2- breast cancer patients[3].

Regulatory and Economic Considerations

Cost and Accessibility

The cost of therapy is a significant factor in the adoption of HRT. For instance, ORSERDU, a SERD, is priced at approximately USD 21,000 per month, highlighting the economic considerations that patients and healthcare systems must navigate[3].

Regulatory Hurdles

Regulatory approvals and changes in healthcare policies can significantly impact the market. As more women take an active role in managing their menopausal health, regulatory environments that support the development and approval of HRT products will be crucial for market growth[5].

Key Takeaways

  • Clinical Evidence: Estrogen-alone therapy has been shown to reduce breast cancer incidence in clinical trials.
  • Market Growth: The global HRT market, including estradiol, is projected to grow significantly, driven by an aging population and increasing awareness of menopausal health.
  • Regional Dynamics: North America and Europe are key markets, with the Asia-Pacific region offering future growth opportunities.
  • Competitive Landscape: The market is competitive, with several key players investing in R&D.
  • Emerging Therapies: SERDs are emerging as potential game-changers in the treatment of breast cancer and other conditions.

FAQs

Q1: What is the current evidence on the impact of estrogen-alone therapy on breast cancer incidence?

The totality of randomized clinical trial evidence supports a conclusion that estrogen-alone use significantly reduces breast cancer incidence, with a relative risk of 0.77 (95% CI 0.65-0.91, P = 0.002)[1].

Q2: How is the global HRT market expected to grow in the coming years?

The global HRT market is expected to grow from USD 37.40 billion in 2024 to USD 66.98 billion by 2034, with a CAGR of 6% from 2025 to 2034[2].

Q3: What are the key drivers of the estradiol gel market?

The key drivers include the rising incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[5].

Q4: Which regions are expected to see significant growth in the estradiol gel market?

North America and Europe are currently the main markets, but the Asia-Pacific region is expected to offer significant growth opportunities due to its rapidly aging population and improving healthcare infrastructure[5].

Q5: What are SERDs, and how are they impacting the market?

SERDs are Selective Estrogen Receptor Degraders used in the treatment of breast cancer. They are expected to transform the market landscape with their potential in both metastatic and early-stage HR+/HER2- breast cancer patients, offering new standards of care and unlocking opportunities for medical innovation and economic growth[3].

Sources

  1. Randomized trials of estrogen-alone and breast cancer incidence. PubMed, 2024.
  2. Hormone Replacement Therapy Market size to hit USD 66.98 billion. Precedence Research, 2024.
  3. SERD Market is Predicted to Exhibit Remarkable Growth. GlobeNewswire, 2024.
  4. Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Events in Postmenopausal Women with Established Coronary Heart Disease. JAMA, 1998.
  5. Global Estradiol Gel Market Research Report 2024. Valuates Reports, 2024.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.