CLINICAL TRIALS PROFILE FOR ESTRACE

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.

Clinical Trial Conditions for Estrace

Condition Name

Condition Name for Estrace
Intervention	Trials
Atrophic Vaginitis	3
Postmenopause	2
Atherosclerosis	2
PTSD	2

Condition MeSH

Condition MeSH for Estrace
Intervention	Trials
Atrophy	7
Breast Neoplasms	4
Vaginitis	4
Atrophic Vaginitis	4

Clinical Trial Locations for Estrace

Trials by Country

Trials by Country for Estrace
Location	Trials
United States	113
Chile	1
Canada	1

Trials by US State

Trials by US State for Estrace
Location	Trials
California	8
Florida	7
Pennsylvania	7
Virginia	6
North Carolina	6

Clinical Trial Progress for Estrace

Clinical Trial Phase

Clinical Trial Phase for Estrace
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	6
Phase 3	9

Clinical Trial Status

Clinical Trial Status for Estrace
Clinical Trial Phase	Trials
Completed	17
Not yet recruiting	7
Recruiting	5

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

Sponsor Type

Sponsor Type for Estrace
Sponsor	Trials
Other	36
Industry	15
NIH	10

Estrace Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Status of Clinical Trials for Estrace?

Estrace (estradiol) is a hormone replacement therapy primarily indicated for menopausal hot flashes, vulvar and vaginal atrophy, osteoporosis prevention, and menstrual irregularities. It has a well-established safety profile, but there are limited ongoing clinical trials focused on new indications or formulations.

Ongoing and Recent Clinical Trials

• No recent or active Phase I-III trials for new formulations or indications registered on ClinicalTrials.gov as of Q1 2023.
• Past trials include studies on hormone replacement therapy safety, efficacy in osteoporosis, and breast cancer risk mitigation.
• No data indicating significant pipeline activity for Estrace in advanced clinical development stages.

Regulatory Status and Approvals

• Regulatory approval in multiple countries, including the US (FDA), Europe (EMA), and Japan (PMDA).
• No recent filings for new formulations or indications have been publicly announced or approved post-2020.

How Does the Market for Estrace Compare to Alternatives?

Market Share and Competitive Landscape

Product Name	Formulation	Approvals	Estimated US Market Share (2022)	Key Competitors
Estrace (estradiol)	Cream, oral, patch	FDA, EMA, PMDA	45%	Vivelle-Dot, Femring, Divigel
Vivelle-Dot (estradiol)	Patch	FDA, EMA	20%	Estrace, Femring
Divigel (estradiol gel)	Gel	FDA, EMA	10%	Estrace, Estring
Other generic formulations	Varying	Marketed under generics	25%	Multiple competitors, including compounded therapies

Market Size

• US menopause hormone therapy market estimated at USD 1.2 billion in 2022.
• Estrace captures the largest share among topical and oral estradiol products.
• The segment for vaginal estrogen products (includes Estrace vaginal cream) was valued at approximately USD 300 million in 2022, with Estrace accounting for a major portion.

Pricing and Reimbursement

• Estrace cream: Average price $200 per tube (30g), reimbursed through private and public insurers.
• Cost advantage over some newer, branded alternatives noted in formulary listings.

What Are Market Projections for Estrace?

Revenue Forecasts

• Overall hormone replacement therapy market expected to grow at CAGR 3-4% from 2023 to 2028.
• Estrace's market share stabilized over recent years due to patent expiry of some formulations and the rise of bioidentical compounded therapies.

Growth Drivers

• Increasing aging population globally.
• Elevated awareness and diagnosis rates of menopause-related symptoms.
• Constant demand for established, off-patent therapies due to cost-effectiveness.

Challenges

• Emerging preference for non-hormonal therapies.
• Tightening regulation around hormone therapy safety.
• Competition from newer, potentially more user-friendly delivery systems like patches and vaginal rings.

Opportunities

• Potential for reformulation or new delivery systems to extend lifecycle.
• Expansion into emerging markets with increasing healthcare infrastructure investment.
• Diversification into biosimilars or combination therapies.

What Are Key Strategic Considerations?

• Pipeline activity: No significant ongoing clinical trials suggest limited near-term innovation.
• Market saturation: The market has a high penetration of generics and biosimilars.
• Regulatory pressures: Need for continuous safety updates to maintain market access.
• Potential partnerships: Opportunities exist for licensing or co-marketing with newer delivery system developers.

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Key Takeaways

• No current high-profile clinical trials for Estrace.
• Market share largely stable, with competitors gaining ground through alternative formulations.
• US market projected to grow modestly driven by demographic trends.
• Price and reimbursement remain favorable, but innovation is needed to sustain growth.
• Growth prospects depend on reformulation strategies and expansion into emerging markets.

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FAQs

1. Are there any upcoming clinical trials for Estrace?
   No significant clinical trials for new formulations or indications are registered as of early 2023.

2. What is the main competition for Estrace?
   The main competitors include vaginal estrogen products like Femring and Divigel, and transdermal patches like Vivelle-Dot.

3. What is the market size for Estrace?
   In 2022, the US market for estrogen therapies was approximately USD 1.2 billion, with Estrace being a leading product.

4. Can Estrace benefit from patent protection?
   The original patents have expired, leading to generic competition; reformulation efforts are needed for lifecycle extension.

5. What opportunities exist for growth?
   Opportunities include developing new delivery methods, expanding into emerging markets, and leveraging combination therapies.

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Citations

1. ClinicalTrials.gov. "Estrace Clinical Trials." Accessed January 2023.
2. IQVIA. "US Menopause Hormone Therapy Market Data." 2022.
3. EvaluatePharma. "Hormone Replacement Therapy Market Forecast." 2023.
4. DailyMed. "Estrace (estradiol) Product Label." 2022.
5. Statista. "Estrogen Therapy Market Size." 2022.