Silicone Gel vs. Estrogen Cream for Genitourinary Syndrome
(VITAL-E Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stratpharma AG
Disqualifiers: Estrogen contraindication, Allergy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment called StrataMGT for women experiencing Genitourinary Syndrome of Menopause (GSM). It aims to see if StrataMGT can improve their quality of life as well as the standard estrogen vaginal cream. Participants will use either StrataMGT or estrogen cream for a period of time and will be monitored regularly.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Estrace 0.01% Vaginal Cream for treating genitourinary syndrome?
Research shows that low-dose vaginal estrogen treatments, like Estrace, are effective in improving symptoms of genitourinary syndrome, such as vaginal dryness and atrophy (thinning and inflammation of the vaginal walls), with minimal increase in estrogen levels in the body.
12345Is it safe to use silicone gel or estrogen cream for genitourinary syndrome?
Vaginal estrogen products, like estradiol creams, are generally considered safe when used at the lowest effective dose for treating genitourinary syndrome of menopause. However, the safety can depend on the amount and duration of use, and it's important to follow medical advice for monitoring and dosage.
46789How does Estrace 0.01% Vaginal Cream differ from other treatments for genitourinary syndrome?
Estrace 0.01% Vaginal Cream is unique because it delivers a low dose of estradiol (a form of estrogen) directly to the vaginal area, which can effectively alleviate symptoms of genitourinary syndrome of menopause with minimal systemic absorption, reducing the risk of side effects compared to higher-dose estrogen treatments.
124610Eligibility Criteria
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.Inclusion Criteria
Able to provide informed consent
I have been diagnosed with menopause-related genital and urinary problems.
Access to a smartphone, tablet or computer, and to a functional email address.
+1 more
Exclusion Criteria
I am unable to understand and give consent for treatment.
Allergy or intolerance to ingredients or excipients of the formulation of studied products
Patient unable to apply topical device
+1 more
Participant Groups
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.
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.
Estrace 0.01% Vaginal Cream is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Estrace 0.01% Vaginal Cream for:
- Moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause
🇨🇦 Approved in Canada as Estradiol 0.01% Vaginal Cream for:
- Atrophic vaginitis, kraurosis vulvae, and moderate to severe dyspareunia
🇪🇺 Approved in European Union as Estradiol 0.01% Vaginal Cream for:
- Vulvar and vaginal atrophy due to estrogen deficiency
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medcare ResearchMiami, FL
Abba Medical GroupMiami, FL
One Health Research ClinicJohns Creek, GA
Orange Coast Women's Medical GroupLaguna Hills, CA
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Who Is Running the Clinical Trial?
Stratpharma AGLead Sponsor
References
Compliance to vaginal treatment-tablets versus cream: a retrospective 9 years study. [2018]Local estrogens are used for the treatment of genitourinary symptoms of menopause. The efficacy and adverse effects of both estrogen-containing vaginal tablets (VT) and estrogen-containing vaginal creams (VC)/gels are comparable. Our objective was to assess the compliance and adherence to treatment in a large population.
A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. [2021]The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream.
Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. [2016]The study aim is to evaluate the efficacy and safety of two low-dose vaginal estrogen treatments (ETs) and of a non-hormonal vaginal moisturizer in postmenopausal breast cancer survivors with urogenital atrophy. Eighteen patients receiving estriol cream 0.25 mg (n = 10) or estradiol tablets 12.5 microg (n = 8) twice/week for 12 weeks were evaluated and compared with eight patients treated with polycarbophil-based moisturizer 2.5 g twice/week. Severity of vaginal atrophy was assessed using subjective [Vaginal Symptoms Score (VSS), Profile of Female Sexual Function (PFSF)] and objective [Vaginal Health Index (VHI), Karyopycnotic Index (KI)] evaluations, while safety by measuring endometrial thickness and serum sex hormones levels. After 4 weeks, VSS and VHI were significantly improved by both vaginal ETs, with further improvement after 12 weeks. PFSF improved significantly only in estriol group (p = 0.02). Safety measurements did not significantly change. Vaginal moisturizer improved VSS at week 4 (p = 0.01), but score returned to pre-treatment values at week 12; no significant modification of VHI, KI, PFSF was recorded. Both low-dose vaginal ET are effective for relieving urogenital atrophy, while non-hormonal moisturizer only provides transient benefit. The increase of serum estrogens levels during treatment with vaginal estrogen at these dosages is minimal.
Implications of the Pharmacovigilance Risk Assessment Committee recommendations for the treatment of genitourinary syndrome. [2021]The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued statements regarding limiting the use of high-dose oestradiol creams by women experiencing the genitourinary syndrome of menopause, and such statements carry much medicolegal weight. Although a low dose is most often used, some clinicians opt to use higher dose creams with close monitoring of the patient. The committee should publish the evidence behind these statements or amend its official position.
Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy. [2019]To determine if the efficacy of continuous low dose estradiol released from a vaginal ring is equivalent to estriol vaginal cream regarding improvement of the patient's subjective feeling of vaginal dryness and to determine if there is a preference for either of the two study treatments.
Intravaginal Drug Delivery Systems to Treat the Genitourinary Syndrome of Menopause: Towards the Design of Safe and Efficacious Estrogen-loaded Prototypes. [2023]Estrogens locally delivered to the vagina by tablets, capsules, rings, pessaries, and creams are the most common and highly recommended platforms to treat the genitourinary syndrome of menopause (GSM). Estradiol, an essential estrogen, is routinely administered alone, or in combination with progestins, to effectively alleviate the symptoms associated with moderate to severe menopause when non-pharmacological interventions are not indicated. Since the risk and side effects of estradiol use depends on the administered amount and duration of use, the lowest effective dose of estradiol is recommended when long-term treatment is required. Although there is a wealth of data and literature comparing vaginally administered estrogen-containing products, there is a lack of information revealing the effect of the delivery system used and formulation constituent's attributes on the efficacy, safety, and patient acceptability of these dosage forms. This review therefore aims to classify and compare various designs of commercially available and non-commercial vaginal 17β-estradiol formulations and analyze their performance in terms of systemic absorption, efficacy, safety, and patient satisfaction and acceptance. The vaginal estrogenic platforms included in this review are the currently marketed and investigational 17β-estradiol tablets, softgel capsules, creams, and rings for the treatment of GSM, based on their different design specifications, estradiol loads, and materials used in their preparation. Additionally, the mechanisms of the effects of estradiol on GSM have been discussed, as well as their potential impact on treatment efficacy and patient compliance.
A systematic review of the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause. [2020]We updated a systematic review to evaluate the totality of evidence available for the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause (GSM) based on published randomized controlled trials.
A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol. [2018]The aim of the study was to evaluate the safety and efficacy of vaginal estradiol (E2) softgel capsules for moderate-to-severe symptoms of vulvar and vaginal atrophy (VVA). Previous phase 1 studies showed lower systemic estrogen concentrations with this softgel capsule compared with an approved low-dose vaginal E2 tablet.
17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. [2022]The efficacy and safety of 25-microg 17beta-estradiol vaginal tablets (Vagifem) were assessed and compared with 1.25-mg conjugated equine estrogen vaginal cream (Premarin Vaginal Cream) for the relief of menopausal-derived atrophic vaginitis, resulting from estrogen deficiency.
Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. [2015]To prove non-inferiority of the first non-hormonal vaginal cream in Germany, Vagisan(®) Moisturising Cream (CREAM), compared to a non-hormonal vaginal gel (GEL) for vulvovaginal atrophy (VVA) symptom relief.