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<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol

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.

Clinical Trial Conditions for ESTROGEL

Condition Name

Condition Name for ESTROGEL
Intervention	Trials
Healthy Volunteers	1
Infertility	1
Menopause	1

Condition MeSH

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

Clinical Trial Locations for ESTROGEL

Trials by Country

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−

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

Trials by US State

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−

Trials by US State for ESTROGEL
Location	Trials
Maryland	2
Virginia	2
Georgia	1
Florida	1
Connecticut	1

Clinical Trial Progress for ESTROGEL

Clinical Trial Phase

Clinical Trial Phase for ESTROGEL
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	3

Clinical Trial Status

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

Clinical Trial Sponsors for ESTROGEL

Sponsor Name

Sponsor Name for ESTROGEL
Sponsor	Trials
AgoneX Biopharmaceuticals, Inc.	1
BioHealthonomics Inc.	1
Simbec Research	1

Sponsor Type

Sponsor Type for ESTROGEL
Sponsor	Trials
Industry	8
Other	3
NIH	1

Estradiol Gel (EstroGel): Clinical Trials, Market Analysis, and Projections

Introduction to Estradiol Gel (EstroGel)

Estradiol gel, commonly known by the brand name EstroGel, is a transdermal hormone replacement therapy used to alleviate symptoms associated with menopause, such as hot flashes, vaginal dryness, and mood swings. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Vasomotor Symptoms

Clinical trials have consistently shown that estradiol gel is effective in reducing the frequency and severity of vasomotor symptoms in postmenopausal women. A pivotal efficacy trial reanalyzed data to explore the impact of age, uterine status, and ovarian status on the efficacy of estradiol gel 0.1%. The results indicated that treatment with estradiol gel 0.1% significantly reduced both the frequency and severity of moderate to severe vasomotor symptoms, regardless of age, uterine status, or ovarian status[1].

Vaginal and Vulvar Atrophy

In addition to vasomotor symptoms, estradiol gel has been shown to improve vaginal and vulvar atrophy. A placebo-controlled study involving 145 postmenopausal women demonstrated a statistically significant increase in the percent of superficial epithelial cells at week 12 for women treated with 1.25 g of EstroGel, compared to the placebo group[4].

Safety and Tolerability

The safety profile of estradiol gel has been evaluated in several clinical trials. Application site reactions, such as pruritus and rash, were reported by a small percentage of patients. However, these reactions were generally mild and did not lead to significant discontinuation rates[4].

Market Analysis

Current Market Size and Growth

The global estradiol gel market was valued at US$ 79 million in 2023 and is projected to reach US$ 127 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period 2024-2030[2].

Key Drivers

Several factors are driving the growth of the estradiol gel market:

• Increasing Incidence of Menopausal Symptoms: The rising incidence of menopausal symptoms such as hot flashes, vaginal dryness, and mood swings is a significant driver.
• Aging Population: The global population is aging, leading to an increased demand for hormone replacement therapies.
• Changing Cultural Views: Growing societal acceptance of menopause as a normal stage of life rather than a disease is promoting the use of hormone replacement treatments[2].

Regional Market

The market for estradiol gel is well-established in North America, driven by a high number of women going through menopause and a strong healthcare infrastructure. Europe also represents a significant market due to its aging population and progressive views on women's health. The Asia-Pacific region offers promising growth opportunities as awareness of menopausal health and treatment options increases[2].

Competitive Landscape

The estradiol gel market includes key players such as Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, and Wuhan Jianmin Group. Recent developments include the FDA approval and launch of generic versions of estradiol gel, such as ANI Pharmaceuticals' generic Estradiol Gel 0.06%, which is expected to enhance accessibility and competition in the market[2][3].

Market Projections

Future Growth

The estradiol gel market is anticipated to continue growing due to several factors:

• Increasing Awareness: Growing awareness of menopausal health and treatment options is expected to drive demand.
• Aging Population: The global aging population will continue to increase the need for hormone replacement therapies.
• Generic Entries: The introduction of generic versions, such as ANI Pharmaceuticals' Estradiol Gel 0.06%, will make the treatment more accessible and affordable, further boosting market growth[2][3].

Global Hormone Replacement Therapy Market Context

The broader hormone replacement therapy (HRT) market, of which estradiol gel is a part, is also expected to grow significantly. The global HRT market is projected to reach USD 35.42 billion by 2030, growing at a CAGR of 6.4% from 2025 to 2030. The Asia-Pacific region is expected to be the fastest-growing market segment within this broader category[5].

Key Takeaways

• Efficacy: Estradiol gel is effective in reducing vasomotor symptoms and improving vaginal and vulvar atrophy in postmenopausal women.
• Market Growth: The global estradiol gel market is expected to grow at a CAGR of 7.3% from 2024 to 2030.
• Regional Markets: North America and Europe are significant markets, with the Asia-Pacific region offering future growth opportunities.
• Competitive Landscape: The market includes several key players, with recent generic entries expected to enhance competition and accessibility.
• Broader HRT Market: The global HRT market is also projected to grow, driven by increasing awareness and an aging population.

FAQs

What is the current market size of the estradiol gel market?

The global estradiol gel market was valued at US$ 79 million in 2023[2].

What is the projected growth rate of the estradiol gel market?

The estradiol gel market is expected to grow at a CAGR of 7.3% from 2024 to 2030[2].

Which regions are the largest markets for estradiol gel?

North America and Europe are currently the largest markets, with the Asia-Pacific region showing significant growth potential[2].

Who are the key players in the estradiol gel market?

Key players include Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, BSV Group, and Wuhan Jianmin Group[2].

What are the main drivers of the estradiol gel market growth?

The main drivers include the increasing incidence of menopausal symptoms, an aging population, and changing cultural views toward women's health[2].

Sources

1. PubMed: Estradiol Gel 0.1% Relieves Vasomotor Symptoms Independent of Age, Uterine, or Ovarian Status.
2. Valuates Reports: Global Estradiol Gel Market Research Report 2024.
3. Stock Titan: ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.06%.
4. FDA: EstroGel® 0.06% (estradiol gel) Label.
5. Mordor Intelligence: Global Hormone Replacement Therapy Market Size.