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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.

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities to participate in this investigation?

"The clinicaltrial.gov website does not list this trial as actively recruiting patients, with the initial post being dated March 1st 2023 and last update on January 3rd 2023. Nonetheless, there are still 1348 other studies that require participants at this time."

Answered by AI