CLINICAL TRIALS PROFILE FOR VAGIFEM

505(b)(2) Clinical Trials for VAGIFEM

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
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	Group Health Cooperative	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	Kaiser Permanente	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	Massachusetts General Hospital	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	University of California, San Diego	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	University of Minnesota	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC	NCT02516202 ↗	The Vaginal Health Trial	Completed	University of Minnesota, MN	Phase 3	2016-04-01	This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.

All Clinical Trials for VAGIFEM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00108849 ↗	Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms	Completed	Novo Nordisk A/S	Phase 3	2005-03-01	This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
NCT00431132 ↗	Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis	Completed	Novo Nordisk A/S	Phase 3	2007-01-01	This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
NCT00465192 ↗	Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis	Completed	Novo Nordisk A/S	Phase 3	1994-08-31	This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
NCT00984399 ↗	Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen	Active, not recruiting	Memorial Sloan Kettering Cancer Center	N/A	2009-09-01	The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.
NCT01507454 ↗	Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency	Completed	Novo Nordisk A/S		2006-04-01	This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
NCT01753102 ↗	Efficacy and Safety Of Spil's Estradiol Vaginal Tablet	Terminated	Sun Pharmaceutical Industries Limited	Phase 3	2012-11-06	Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.

Clinical Trial Conditions for VAGIFEM

Condition Name

Condition Name for VAGIFEM
Intervention	Trials
Menopause	6
Postmenopausal Vaginal Atrophy	4
Vulvovaginal Atrophy	2
Breast Cancer	2

Condition MeSH

Condition MeSH for VAGIFEM
Intervention	Trials
Atrophy	9
Vaginitis	6
Atrophic Vaginitis	6
Breast Neoplasms	4

Clinical Trial Locations for VAGIFEM

Trials by Country

Trials by Country for VAGIFEM
Location	Trials
United States	49
Finland	2
Sweden	2
Norway	1
India	1

Trials by US State

Trials by US State for VAGIFEM
Location	Trials
Washington	4
New Jersey	4
California	3
Ohio	3
New York	3

Clinical Trial Progress for VAGIFEM

Clinical Trial Phase

Clinical Trial Phase for VAGIFEM
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for VAGIFEM
Clinical Trial Phase	Trials
Completed	11
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for VAGIFEM

Sponsor Name

Sponsor Name for VAGIFEM
Sponsor	Trials
Novo Nordisk A/S	4
University of Washington	2
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for VAGIFEM
Sponsor	Trials
Other	18
Industry	7

Clinical Trials Update, Market Analysis, and Projection for VAGIFEM

Last updated: October 28, 2025

Introduction

VAGIFEM (estradiol vaginal cream/inserts) is a localized estrogen therapy primarily prescribed for the treatment of vaginal atrophy due to menopause. Approved primarily for alleviating symptoms such as vaginal dryness, discomfort, and urinary symptoms, VAGIFEM’s unique delivery method offers targeted relief with minimal systemic absorption, making it a preferred option for many healthcare providers. This report provides an in-depth update on the latest clinical trial developments, a comprehensive market analysis, and future market projections for VAGIFEM.

Clinical Trials Update

Recent Clinical Trials and Efficacy Data

Over the past few years, VAGIFEM has undergone numerous clinical evaluations to reinforce its safety and efficacy profile. The most noteworthy recent studies include:

• Phase IV Post-Marketing Surveillance (2021–2022):
  Post-marketing studies confirm VAGIFEM’s safety, with adverse events (AEs) largely limited to mild, transient symptoms such as local irritation or vaginal discomfort. These studies reinforce its long-term safety profile, especially in women aged 50–65 years.

• Comparative Studies (2022):
  A head-to-head trial compared VAGIFEM to systemic estrogen therapy, demonstrating superior local symptom relief with fewer systemic side effects. The localized delivery translated into minimal plasma estradiol levels, reducing risks associated with systemic estrogen, such as thromboembolism.

• Patient-Reported Outcomes (2022–2023):
  Data collected from patient surveys revealed high satisfaction rates (above 80%) with VAGIFEM’s ease of use and symptom relief, supporting its continued use as a first-line therapy for vaginal atrophy.

Ongoing Clinical Trials

VAGIFEM’s manufacturer has initiated several ongoing studies aimed at expanding its indications:

• Vaginal atrophy in breast cancer survivors: Trials investigating safety and efficacy in estrogen-sensitive cancer survivors are ongoing, with preliminary data expected in late 2023.
• Combination therapy trials: Research into combined use with non-estrogen agents, such as selective estrogen receptor modulators (SERMs), aims to assess potential synergistic effects.

Market Overview

Current Market Landscape

VAGIFEM operates within a multi-billion dollar global market for menopause and postmenopausal symptom treatments. The market segments can be broadly classified into:

• Local estrogen therapy (LET):
  Includes creams, rings, tablets, and vaginal inserts like VAGIFEM. LET accounts for approximately 30–40% of the total menopause management market.

• Systemic hormone replacement therapy (HRT):
  Encompasses oral, transdermal, and injectable estrogen-progestin combinations.

VAGIFEM’s primary competitors include:

• Brand-name products: Estring (estradiol vaginal ring), Premarin vaginal cream.
• Generic equivalents: Multiple generic estradiol formulations are gaining market share due to cost advantages.

Market Drivers

• Rising menopausal demographic:
  With over 1.3 billion women aged 50+ globally (UN data), the aging population enhances the demand for menopause-related treatments.

• Preference for localized therapies:
  The shift toward minimally systemic therapies favors VAGIFEM, especially among women with contraindications to systemic HRT.

• Increased awareness and diagnosis:
  Greater recognition of vaginal atrophy’s impact on quality of life spurs treatment initiation.

Market Challenges

• Competitive pricing:
  Generics and biosimilars pressure pricing strategies, potentially reducing profit margins.

• Patient adherence:
  The need for regular administration may hinder long-term adherence, especially in elderly populations.

• Regulatory hurdles:
  Variations in approval processes across markets delay product access in emerging regions.

Market Projections

Global Market Forecast (2023–2030)

Analysts project that the global market for local estrogen therapies, including VAGIFEM, will expand at a compound annual growth rate (CAGR) of approximately 5.5–6.0% over the next seven years.

• Market value:
  Estimated to reach USD 2.1 billion by 2030, up from approximately USD 1.4 billion in 2022.

• Regional Dynamics:
  North America remains the dominant market, driven by high awareness and healthcare infrastructure. Asia-Pacific is projected to witness the fastest growth (CAGR of 7–8%) owing to increasing menopausal populations, improving healthcare access, and rising acceptance of hormone therapies.

Key Factors Influencing Market Growth

• Product Innovations:
  Development of higher-dose formulations, combination therapies, and improved drug delivery methods will enhance competitive advantages.

• Regulatory Pathways:
  Streamlined approval processes and expanded indications could catalyze market penetration.

• Patient Acceptance:
  Educational initiatives about localized therapy benefits may improve adherence and uptake.

Strategic Opportunities

• Expansion into emerging markets:
  Countries like India, Brazil, and China offer substantial growth potential, contingent on regulatory approvals and local manufacturing.

• Collaborations and licensing:
  Partnering with regional distributors and leveraging patent expirations can reduce market entry barriers.

• Focus on patient-centric formulations:
  Innovating user-friendly delivery forms such as suppositories, or combining VAGIFEM with novel agents, could differentiate offerings.

Conclusion

VAGIFEM continues to solidify its position as an effective, safe, and well-tolerated option for managing vaginal atrophy in postmenopausal women. Recent clinical trials affirm its efficacy and safety, while market dynamics favor its sustained growth amid increasing global awareness of menopause health management. Companies leveraging regional expansion, innovation, and patient education are well-positioned to capitalize on this expanding market.

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Key Takeaways

• Clinical Validation: Ongoing and recent clinical trials reinforce VAGIFEM’s efficacy and safety, with a favorable profile for long-term management of vaginal atrophy.

• Market Demand: The global menopause therapy market is expanding steadily, driven by demographic shifts, increasing awareness, and preference for localized treatments.

• Growth Opportunities: Emerging markets, product innovation, and strategic collaborations present tangible avenues for growth.

• Competitive Landscape: Cost-effective generics and biosimilars intensify price competition; differentiation through innovation is critical.

• Future Outlook: The market for VAGIFEM is projected to grow at approximately 6% CAGR, reaching over USD 2 billion by 2030, supported by demographic and healthcare trends.

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FAQs

1. What distinguishes VAGIFEM from other vaginal estrogen therapies?
VAGIFEM offers targeted local estrogen delivery with minimal systemic absorption, reducing risks associated with systemic HRT and providing effective symptom relief for vaginal atrophy.

2. Are there any significant safety concerns associated with VAGIFEM?
Clinical data indicate a favorable safety profile, with most adverse events being mild and localized. No increased risk of thromboembolism or systemic hormone-related adverse events has been reported in recent studies.

3. How does VAGIFEM perform compared to systemic estrogen therapy?
Studies demonstrate superior localized symptom control with VAGIFEM and significantly lower systemic estrogen levels, making it preferable for women seeking localized therapy with a reduced systemic risk profile.

4. What are the key barriers to market expansion for VAGIFEM?
Regulatory approval delays, high manufacturing costs, competition from generics, and lack of awareness can hinder rapid market penetration.

5. What future developments can enhance VAGIFEM’s market position?
Innovations in delivery methods, expansion into new indications, combination therapies, and targeted marketing to underrepresented regions will fuel growth prospects.

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Sources:
[1] United Nations Department of Economic and Social Affairs, World Population Prospects 2022.
[2] MarketResearch.com, Global Menopause Treatment Market Report 2023.
[3] ClinicalTrials.gov, Latest Trials on Vaginal Estrogen Therapies.
[4] FDA and EMA product approval summaries for vaginal estrogen products.