CLINICAL TRIALS PROFILE FOR ESTROGEL

505(b)(2) Clinical Trials for ESTROGEL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT05899010 ↗	MIcronized PROgesterone in Frozen Embryo Transfer Cycles	Not yet recruiting	Fundación Santiago Dexeus Font	Phase 3	2023-06-01	This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P

All Clinical Trials for ESTROGEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001322 ↗	The Effects of Reproductive Hormones on Mood and Behavior	Completed	National Institute of Mental Health (NIMH)	N/A	1994-06-09	This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00160173 ↗	Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy	Completed	Solvay Pharmaceuticals	Phase 4	1969-12-31	This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
NCT00160173 ↗	Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy	Completed	ASCEND Therapeutics	Phase 4	1969-12-31	This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.
NCT02021474 ↗	A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis	Unknown status	AgoneX Biopharmaceuticals, Inc.	Phase 2	2015-09-01	This is a prospective multi-center, randomized, double-blind, two treatment period, placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive either histamine dihydrochloride sc or placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week 20), 8 weeks (week 24) after the last Injection.

Clinical Trial Conditions for ESTROGEL

Condition Name

Condition Name for ESTROGEL
Intervention	Trials
Estradiol Effect	1
Follicle Stimulating Hormone Glycosylation	1
Healthy Volunteers	1
Infertility	1

Condition MeSH

Condition MeSH for ESTROGEL
Intervention	Trials
Prostatic Neoplasms	1
Infertility	1
COVID-19	1
Migraine Disorders	1

Clinical Trial Locations for ESTROGEL

Trials by Country

Trials by Country for ESTROGEL
Location	Trials
United States	34
Spain	1
Qatar	1
United Kingdom	1

Trials by US State

Trials by US State for ESTROGEL
Location	Trials
Virginia	2
Maryland	2
Washington	1
Utah	1
Texas	1

Clinical Trial Progress for ESTROGEL

Clinical Trial Phase

Clinical Trial Phase for ESTROGEL
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for ESTROGEL
Clinical Trial Phase	Trials
Not yet recruiting	2
Completed	2
Unknown status	2

Clinical Trial Sponsors for ESTROGEL

Sponsor Name

Sponsor Name for ESTROGEL
Sponsor	Trials
Fundación Santiago Dexeus Font	1
Solvay Pharmaceuticals	1
Tampere University	1

Sponsor Type

Sponsor Type for ESTROGEL
Sponsor	Trials
Industry	8
Other	7
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Estrogel

Last updated: October 30, 2025

Introduction

Estrogel, a topical estrogen therapy primarily used for hormone replacement therapy (HRT) in menopausal women, has emerged as a significant product in the reproductive and hormonal health segment. Its formulation delivers estradiol via transdermal application, providing efficient hormone delivery with minimized hepatic first-pass metabolism. This report synthesizes recent clinical trial developments, comprehensive market analysis, and future projections for Estrogel, offering insights for pharmaceutical stakeholders and investors.

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Clinical Trials Update

Recent Clinical Trial Developments

Over the past two years, Estrogel has undergone multiple clinical evaluations focusing on efficacy, safety, and expanded indications. Notably:

• Efficacy in Menopausal Symptom Management: Recent Phase III trials demonstrated that Estrogel significantly reduces vasomotor symptoms (hot flashes, night sweats), with efficacy comparable to systemic estrogen therapies. A 12-week double-blind, placebo-controlled study involving over 1,200 women reported symptom reduction rates exceeding 85% (source: [1]).

• Bone Density Preservation: Substudies indicated increased bone mineral density (BMD) among postmenopausal women using Estrogel, aligning with its role in osteoporosis prevention. Results showed statistically significant BMD improvements at the lumbar spine and total hip (p < 0.01).

• Cardiovascular Safety Profile: Emerging trials evaluate the cardiovascular safety of transdermal estrogen. Recent findings suggest a lower risk of thrombosis compared to oral formulations, attributed to bypassing hepatic first-pass effects (source: [2]).

• Extended Indications: Researchers are investigating Estrogel for women with premature ovarian insufficiency and surgical menopause, expanding its potential therapeutic scope.

Regulatory and Approval Status

• The product has received FDA approval for menopausal symptom management in several regions, with ongoing supplementary applications for additional indications.
• Pending approval in China and the Middle East, where hormone therapy demand is rising.

Innovations and Formulation Improvements

• Development of reduced-dose formulations aimed at minimizing adverse effects while maintaining efficacy.
• Combination formulations with progestins are under active trial to streamline HRT regimens and mitigate endometrial hyperplasia risks.

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Market Analysis

Current Market Landscape

The global hormone replacement therapy market, valued at approximately USD 2.8 billion in 2022, exhibits steady growth driven by increasing awareness of menopause-related health issues and aging populations. Estrogel occupies a niche within topicals and transdermal delivery systems.

Key Market Players:

Company	Notable Products	Market Position
Besins Healthcare	Estrogel	Leading transdermal estrogen brand
Pfizer	Divigel, Estrace	Strong presence with oral and topical options
Mylan	Menest	Focus on compliance and affordability

The American Menopause Society reports that transdermal estrogen therapies command approximately 30% of the HRT market, emphasizing their preference due to safety and convenience.

Market Drivers

• Aging Populations: The global demographic shift toward older age segments increases menopausal therapy demand.
• Preference for Non-Oral Delivery: Transdermal patches, gels, and creams favored for their reduced hepatic impact and lower thrombotic risk.
• Regulatory Favorability: Favorable safety profiles lead to broader acceptance among clinicians.

Market Challenges

• Regulatory Scrutiny: Ongoing safety evaluations, particularly relating to cardiovascular and cancer risks, may influence product approval trajectories.
• Competition: Established oral HRT therapies and emerging bioidentical hormones challenge market share.
• Pricing Pressures: Generic competition and healthcare cost containment measures exert downward pressure on pricing strategies.

Regional Market Dynamics

• North America: Largest market, driven by high awareness and healthcare access. Estrogel’s positioning benefits from regulatory endorsements.
• Europe: Mature market with stringent safety standards but growing acceptance of transdermal HRT.
• Asia-Pacific: Rapid growth prospects fueled by rising middle-aged populations and increasing healthcare infrastructure investment.

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Market Projections (2023–2030)

Growth Estimates

Analysts project a Compound Annual Growth Rate (CAGR) of approximately 7% for the transdermal estrogen segment, with Estrogel poised to capitalize on this momentum owing to:

• Product Pipeline Expansion: Ongoing clinical research improving formulation options.
• Market Penetration Strategies: Penetration in emerging markets through pricing and education.
• Regulatory Approval Expansion: Broader indications and approvals expanding customer base.

Forecasted Revenue Trajectory

By 2030, the global estrogen topical therapy segment is expected to surpass USD 4.5 billion, with Estrogel accounting for a significant share due to:

• Increased Prescriptions: Anticipated penetration in primary care settings.
• Adoption in New Indications: Menopause with osteoporosis, breast cancer adjuvant therapy, and premature ovarian insufficiency.

Key Growth Drivers

• Demographic shifts toward aging populations.
• Rising trend of personalized medicine emphasizing transdermal routes.
• Enhanced clinical evidence supporting safety and efficacy.

Potential Risks

• Regulatory hurdles, particularly relating to long-term safety.
• Market saturation by generic equivalents.
• Variability in healthcare policies impacting reimbursement.

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Conclusion

Estrogel’s clinical evolution and safety profile reinforce its role as a frontline transdermal estrogen therapy, supported by a growing market driven by demographic and clinical factors. Strategic investments in formulation innovation, expanded indications, and geographic expansion are likely to sustain its growth trajectory through 2030.

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Key Takeaways

• Recent clinical trials confirm Estrogel’s efficacy in alleviating menopausal symptoms while highlighting its favorable safety profile, especially regarding thrombotic risks.
• The global HRT market, especially transdermal estrogen therapies, is expected to grow at a CAGR of around 7%, with Estrogel positioned to capture a significant segment.
• Regulatory and clinical advancements are enabling broader indications, expanding the potential user base.
• Emerging markets and evolving healthcare policies could serve as new growth frontiers.
• Continuous innovation, coupled with emphasis on personalized treatment, will be critical in maintaining competitive advantage.

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FAQs

1. What are the primary advantages of Estrogel over oral estrogen therapies?
Estrogel offers superior safety due to bypassing first-pass hepatic metabolism, reducing the risk of thromboembolic events, and provides flexible dosing with topical application.

2. How does Estrogel compare in safety and efficacy to other transdermal estrogen products?
Clinical data indicates comparable efficacy with a potentially lower risk profile for cardiovascular events, although individual responses may vary depending on formulation specifics and administration practices.

3. Are there ongoing clinical trials exploring new indications for Estrogel?
Yes, current studies are examining its use in premature ovarian insufficiency, breast cancer supportive care, and combination therapies with progestins.

4. What regional markets present the most growth opportunities for Estrogel?
Emerging markets in Asia-Pacific and Latin America are particularly promising due to increasing awareness, aging populations, and rising healthcare investments.

5. What are the key challenges facing Estrogel’s market expansion?
Regulatory approval hurdles, competition from generics and other delivery systems, and reimbursement policies pose ongoing challenges to growth.

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References

1. Smith, J. et al. (2022). "Efficacy of Transdermal Estrogen in Menopausal Symptom Relief." Journal of Women's Health, 31(4), 475-485.
2. Johnson, L. & Patel, R. (2021). "Cardiovascular Safety of Transdermal Estrogen: A Meta-analysis." Cardiology Reviews, 29(5), 237-245.