Silicone Gel vs. Estrogen Cream for Genitourinary Syndrome

(VITAL-E Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stratpharma AG

Disqualifiers: Estrogen contraindication, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{4 6 7 8 9}

How 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. ^{1 2 4 6 10}

Eligibility 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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. Monthly assessments for quality of life, clinical signs, symptoms, pathology, and adverse reactions are conducted.

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Estrace 0.01% Vaginal Cream
• StrataMGT

Trial Overview 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.

Participant Groups

Group I: StrataMGT Experimental Treatment 1 Intervention

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

Group II: Estrace Active Control 1 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

Who Is Running the Clinical Trial?

Stratpharma AG

Lead Sponsor

Trials

12

Recruited

3,000+

Findings from Research

In a study of 2,269 postmenopausal women, those using estrogen vaginal tablets (VT) showed significantly better compliance and adherence to treatment compared to those using estrogen vaginal creams (VC), with 64% of VT users continuing treatment for at least 4 months versus only 39% of VC users.

After 6 months, 83% of women using VT requested another prescription, compared to just 54% of those using VC, indicating that VT not only had a longer average treatment duration (1,002 days) but also encouraged continued use more effectively than VC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance to vaginal treatment-tablets versus cream: a retrospective 9 years study. Weissmann-Brenner, A., Bayevsky, T., Yoles, I.[2018]

In a study involving 69 menopausal women, both fractionated CO2 vaginal laser therapy and estrogen vaginal cream showed similar efficacy in improving symptoms of vaginal dryness and genitourinary syndrome after 6 months, with 70% to 80% of participants satisfied with either treatment.

No serious adverse events were reported for either treatment, indicating that both options are safe for managing menopausal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. Paraiso, MFR., Ferrando, CA., Sokol, ER., et al.[2021]

Both low-dose vaginal estrogen treatments (estriol cream and estradiol tablets) significantly improved symptoms of urogenital atrophy in postmenopausal breast cancer survivors over 12 weeks, with effects measured by subjective and objective assessments.

The non-hormonal vaginal moisturizer provided only a temporary improvement in symptoms, highlighting that while both estrogen treatments are effective, the moisturizer's benefits do not last beyond the initial weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. Biglia, N., Peano, E., Sgandurra, P., et al.[2016]

The European Medicines Agency has recommended limiting the use of high-dose oestradiol creams for women with genitourinary syndrome of menopause due to safety concerns, emphasizing the importance of careful monitoring.

There is a call for the committee to provide evidence supporting their recommendations or to reconsider their stance, highlighting the need for transparency in medical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the Pharmacovigilance Risk Assessment Committee recommendations for the treatment of genitourinary syndrome. Buttigieg, GG., Micallef-Stafrace, K.[2021]

In a study involving 165 postmenopausal women, both continuous low-dose estradiol from a vaginal ring and estriol cream were found to be equally effective in relieving vaginal dryness and signs of vaginal atrophy over a 12-week treatment period.

The vaginal ring (Estring) was preferred by patients over the estriol cream, while both treatments showed similar safety profiles with no significant differences in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy. Barentsen, R., van de Weijer, PH., Schram, JH.[2019]

Vaginally delivered estrogens, particularly estradiol, are highly recommended for treating the genitourinary syndrome of menopause (GSM), with the lowest effective dose suggested for long-term use to minimize risks and side effects.

This review highlights the need for more information on how different delivery systems and formulations of vaginal estradiol affect their efficacy, safety, and patient acceptability, as current data is limited despite the variety of available products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravaginal Drug Delivery Systems to Treat the Genitourinary Syndrome of Menopause: Towards the Design of Safe and Efficacious Estrogen-loaded Prototypes. Abdelgader, A., Govender, M., Kumar, P., et al.[2023]

Vaginal estrogen products are effective in treating genitourinary syndrome of menopause (GSM), showing significant improvement in both objective and subjective symptoms compared to placebo, based on a systematic review of 53 studies.

These products appear to be safe with few adverse effects, although long-term safety data is limited, supporting their use as a first-line therapy for moderate-to-severe GSM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause. Biehl, C., Plotsker, O., Mirkin, S.[2020]

In a phase 2 study involving 50 postmenopausal women, vaginal estradiol (E2) softgel capsules significantly improved symptoms of vulvar and vaginal atrophy (VVA) compared to placebo, showing marked increases in beneficial vaginal cell types and decreases in vaginal pH.

The study demonstrated that vaginal E2 softgel capsules are a safe treatment option with lower systemic estrogen absorption than existing intravaginal therapies, with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol. Pickar, JH., Amadio, JM., Hill, JM., et al.[2018]

Both 25-microg 17beta-estradiol vaginal tablets and 1.25-mg conjugated equine estrogen vaginal cream effectively relieve symptoms of atrophic vaginitis in menopausal women, as shown in a study with 159 participants over 24 weeks.

The vaginal tablets were associated with fewer systemic side effects, lower rates of endometrial proliferation, and higher patient satisfaction, leading to a lower withdrawal rate compared to the vaginal cream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. Rioux, JE., Devlin, C., Gelfand, MM., et al.[2022]

In a 12-week study involving 117 women, Vagisan® Moisturising Cream (CREAM) was found to be non-inferior to a non-hormonal vaginal gel (GEL) for relieving symptoms of vulvovaginal atrophy (VVA), and it even showed superior efficacy in reducing both subjective and objective symptoms.

CREAM demonstrated better tolerability than GEL, with fewer reports of burning and itching, and it significantly improved vaginal pH, indicating it may be a safer and more effective option for VVA symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Stute, P., May, TW., Masur, C., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Compliance to vaginal treatment-tablets versus cream: a retrospective 9 years study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Implications of the Pharmacovigilance Risk Assessment Committee recommendations for the treatment of genitourinary syndrome. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intravaginal Drug Delivery Systems to Treat the Genitourinary Syndrome of Menopause: Towards the Design of Safe and Efficacious Estrogen-loaded Prototypes. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. [2015]