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.

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.

Clinical Trial Conditions for Vagifem

Condition Name

Condition Name for Vagifem
Intervention	Trials
Menopause	6
Postmenopausal Vaginal Atrophy	4
Vulvovaginal Atrophy	2

Condition MeSH

Condition MeSH for Vagifem
Intervention	Trials
Atrophy	9
Atrophic Vaginitis	6
Vaginitis	6

Clinical Trial Locations for Vagifem

Trials by Country

Trials by Country for Vagifem
Location	Trials
United States	48
Sweden	2
Finland	1
Norway	1
India	1

Trials by US State

Trials by US State for Vagifem
Location	Trials
Washington	4
New Jersey	4
Ohio	3
New York	3
Georgia	2

Clinical Trial Progress for Vagifem

Clinical Trial Phase

Clinical Trial Phase for Vagifem
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Vagifem
Clinical Trial Phase	Trials
Completed	9
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for Vagifem

Sponsor Name

Sponsor Name for Vagifem
Sponsor	Trials
Novo Nordisk A/S	4
University of Washington	2
University of California, San Diego	1

Sponsor Type

Sponsor Type for Vagifem
Sponsor	Trials
Other	15
Industry	7

Vagifem: Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

The REJOICE Trial and Similar Studies

While the REJOICE trial specifically focused on TX-004HR, a different vaginal estradiol product, it provides valuable insights into the efficacy and safety profile of vaginal estrogen therapies, which are relevant to Vagifem.

• Efficacy Endpoints: Studies like the REJOICE trial have shown that vaginal estradiol products significantly improve symptoms of vulvar and vaginal atrophy (VVA). For Vagifem, clinical trials have demonstrated its efficacy in treating atrophic vaginitis due to menopause. A 12-month double-blind, randomized, parallel group, placebo-controlled study involving 309 postmenopausal women showed that Vagifem 10 mcg inserts improved vaginal cytology, reduced vaginal pH, and alleviated symptoms such as dyspareunia, vaginal dryness, and vulvar and vaginal itching or irritation[4].

• Safety Profile: Vagifem has been found to have a favorable safety profile. The most common adverse reactions reported in clinical trials include back pain, diarrhea, vulvovaginal mycotic infections, and vulvovaginal pruritus. These reactions were generally mild to moderate in severity. There were no significant increases in serious adverse events or clinically meaningful changes in laboratory parameters[4].

Market Analysis

Current Market Size and Growth

The market for vulvar and vaginal atrophy (VVA) therapies, which includes Vagifem, is experiencing significant growth driven by several factors.

• Global Market Size: As of 2025, the VVA therapy market is estimated to be around USD 2.9 billion, up from USD 2.46 billion in 2024. This market is projected to reach USD 9.22 billion by 2037, growing at a CAGR of approximately 10.7% during the forecast period[5].

• Hormone Replacement Therapy Market: The broader hormone replacement therapy (HRT) market, which encompasses VVA therapies, was valued at USD 37.40 billion in 2024 and is expected to grow to USD 66.98 billion by 2034, with a CAGR of 6% from 2025 to 2034. The North American market is the largest and is expected to grow at a CAGR of 6.13% during the forecast period[2].

Growth Drivers

Several factors are driving the growth of the VVA therapy market, including:

• Rising Aging Population: The increasing number of postmenopausal women is a significant driver. Approximately 1.3 million women in the United States enter menopause each year, and this number is expected to rise with the aging population[5].

• Awareness and Diagnosis: Growing awareness about VVA and its treatments among the female population is leading to higher diagnosis rates and better patient compliance. Historically, low diagnosis rates and poor patient compliance have been barriers to market growth[5].

• Regional Growth: The Asia Pacific region is expected to hold the second largest share of the VVA therapy market, driven by increasing awareness and the provision of required medications for geriatric females, who are highly prone to vaginal infections due to estrogen deficiency[5].

Market Projections

Future Market Size

The VVA therapy market, including Vagifem, is projected to experience substantial growth over the next decade.

• By 2037: The market is expected to reach USD 9.22 billion, growing at a CAGR of 10.7% from 2025 to 2037. This growth is driven by the increasing prevalence of VVA, rising awareness, and improved treatment options[5].

• Regional Expansion: The North American market, currently the largest, will continue to grow, while the Asia Pacific region is expected to see significant expansion due to demographic changes and increasing healthcare access[2][5].

Competitive Landscape

Existing Therapies and Challenges

The VVA therapy market faces challenges such as low diagnosis rates and safety concerns associated with existing estrogen-based therapies. For instance, traditional estrogen therapies are linked to elevated risks of breast cancer, endometrial cancer, and stroke, which has led to a large untreated population in the past[3].

Vagifem's Position

Vagifem, with its favorable safety profile and efficacy in treating atrophic vaginitis, is well-positioned in this market. Its specific formulation and delivery method, which circumvents first-pass metabolism, make it an attractive option for women seeking relief from VVA symptoms[4].

Key Takeaways

• Clinical Efficacy: Vagifem has demonstrated significant efficacy in clinical trials for treating symptoms of VVA.
• Safety Profile: The drug has a favorable safety profile with mild to moderate adverse reactions.
• Market Growth: The VVA therapy market is expected to grow substantially, driven by an aging population and increasing awareness.
• Regional Expansion: North America and the Asia Pacific region are key markets for future growth.
• Competitive Advantage: Vagifem's specific formulation and delivery method offer a competitive edge in the market.

FAQs

What is Vagifem used for?

Vagifem is an estrogen product indicated for the treatment of atrophic vaginitis due to menopause.

What are the common adverse reactions associated with Vagifem?

Common adverse reactions include back pain, diarrhea, vulvovaginal mycotic infections, and vulvovaginal pruritus.

How does Vagifem improve VVA symptoms?

Vagifem improves vaginal cytology, reduces vaginal pH, and alleviates symptoms such as dyspareunia, vaginal dryness, and vulvar and vaginal itching or irritation.

What is the projected market size for VVA therapies by 2037?

The VVA therapy market is expected to reach USD 9.22 billion by 2037.

Which regions are expected to drive the growth of the VVA therapy market?

North America and the Asia Pacific region are expected to be key drivers of market growth.

Sources

1. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vaginal atrophy. Menopause Journal.
2. Hormone Replacement Therapy Market size to hit USD 66.98 billion by 2034. Precedence Research.
3. Research and Markets: Vagifem (Postmenopausal Vaginal Atrophy) - Forecast and Market Analysis to 2022. Business Wire.
4. Vagifem ESTRADIOL 10 ug/1 Novo Nordisk. Medthority.
5. Vulvar and Vaginal Atrophy (VVA) Therapy Market Size, Growth, and Forecast. Research Nester.