What is the mechanism of action of this treatment?

Common treatments for Genitourinary Syndrome of Menopause (GSM) include estrogen therapy and silicone-based gels. Estrogen therapy works by replenishing the decreased levels of estrogen in postmenopausal women, which helps to restore the thickness and elasticity of the vaginal and urethral tissues, reducing symptoms like dryness, irritation, and discomfort during intercourse. Silicone-based gels, such as StrataMGT, likely function by providing a protective barrier that maintains moisture and reduces friction, thereby alleviating symptoms of dryness and irritation. These treatments are crucial for improving the quality of life in GSM patients by addressing the underlying causes of their symptoms and providing symptomatic relief.

What side effects are associated with this type of intervention?

Common treatments for Genitourinary Syndrome of Menopause (GSM), such as estrogen vaginal creams, are generally well-tolerated but can have side effects. These may include local irritation, itching, and discharge. Systemic absorption of estrogen can occasionally lead to more widespread effects like breast tenderness, nausea, and headache. In the context of the trial comparing StrataMGT to estrogen vaginal cream, similar local adverse reactions and potential systemic effects might be expected.

What prior FDA approvals exist?

FDA-approved treatments for Genitourinary Syndrome of Menopause (GSM) include estrogen-based therapies such as vaginal creams, tablets, and rings, which help alleviate symptoms by locally replenishing estrogen. Additionally, ospemifene, an oral selective estrogen receptor modulator (SERM), and prasterone (DHEA), a vaginal insert that converts to estrogen and androgen locally, are also approved for treating GSM.

What other types of research exist?

Promising novel alternatives to StrataMGT for the management of Genitourinary Syndrome of Menopause (GSM) include: 1) Vaginal laser therapy, which has shown efficacy in improving GSM symptoms by promoting collagen remodeling and tissue regeneration. 2) DHEA (prasterone) vaginal inserts, which are a non-estrogen hormonal option that can help alleviate GSM symptoms. 3) Ospemifene, an oral selective estrogen receptor modulator (SERM) that has been effective in treating moderate to severe dyspareunia associated with GSM. 4) Hyaluronic acid vaginal gels, which provide moisture and improve vaginal health without hormonal effects.

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Estrogen

Silicone Gel vs. Estrogen Cream for Genitourinary Syndrome (VITAL-E Trial)

N/A

Recruiting

Research Sponsored by Stratpharma AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

VITAL-E Trial Summary

This trial will compare a non-hormonal treatment (StrataMGT) to a hormonal treatment (estrogen) to see which is better at treating GSM and improving quality of life.

Who is the study for?

This trial is for postmenopausal individuals with Genitourinary Syndrome of Menopause (GSM). Participants must be able to give informed consent, have access to a smart device and email. Those who can't apply topical treatments, are allergic to ingredients in the products, or cannot use estrogen therapy are excluded.Check my eligibility

What is being tested?

The study compares StrataMGT silicone gel with Estrace vaginal cream over three months to see which is better for improving life quality in GSM patients. It's a randomized trial where participants get one of the two treatments and report their experiences monthly.See study design

What are the potential side effects?

Potential side effects may include local reactions at the application site such as redness, itching or irritation. Estrogen cream might also cause hormonal side effects like breast tenderness or bleeding.

VITAL-E Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PROM: Quality of Life

Secondary outcome measures

Adverse Reactions

Clinical signs

PROM: Dyspareunia

+4 more

VITAL-E Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: StrataMGTExperimental Treatment1 Intervention

Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.

Group II: EstraceActive Control1 Intervention

Participants will receive Estrace vaginal cream (estrogen) to treat GSM for 3 months. Application will be 1 g daily for the first two weeks. Afterwards, a maintenance dosage of 1 g three times a week is applied.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Genitourinary Syndrome of Menopause (GSM) include estrogen therapy and silicone-based gels. Estrogen therapy works by replenishing the decreased levels of estrogen in postmenopausal women, which helps to restore the thickness and elasticity of the vaginal and urethral tissues, reducing symptoms like dryness, irritation, and discomfort during intercourse. Silicone-based gels, such as StrataMGT, likely function by providing a protective barrier that maintains moisture and reduces friction, thereby alleviating symptoms of dryness and irritation. These treatments are crucial for improving the quality of life in GSM patients by addressing the underlying causes of their symptoms and providing symptomatic relief.

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Who is running the clinical trial?

Stratpharma AGLead Sponsor

10 Previous Clinical Trials

2,880 Total Patients Enrolled

Media Library

Estrace 0.01% Vaginal Cream (Estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT05672901 — N/A

Genitourinary Syndrome Research Study Groups: StrataMGT, Estrace

Genitourinary Syndrome Clinical Trial 2023: Estrace 0.01% Vaginal Cream Highlights & Side Effects. Trial Name: NCT05672901 — N/A

Estrace 0.01% Vaginal Cream (Estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672901 — N/A

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