Gel Dressing 7-0940 for Vulvovaginal Atrophy

(VALOR Trial)

Recruiting at 11 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stratpharma AG

Must not be taking: Hormonal therapy, Corticosteroids

Disqualifiers: Allergy, Systemic hormonal therapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel dressing, 7-0940, designed to treat vulvovaginal atrophy and other skin conditions such as lichen sclerosus and lichen planus. The goal is to assess the safety and effectiveness of this gel over time. Individuals diagnosed with these conditions and experiencing ongoing symptoms might be suitable candidates. Participants need access to a smartphone or computer and an email address. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance treatment options for these conditions.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. If you are using systemic hormonal therapy or corticosteroids, you must have stopped them at least 30 days before starting the trial. Ongoing use of these treatments is not allowed.

What prior data suggests that this gel dressing is safe for treating vulvovaginal atrophy?

Research has shown that similar vaginal gels have been well-tolerated by patients. For example, a study found that another vaginal gel, Feminilove, was safe and effective for easing vaginal dryness. Although this is not the exact gel being tested, it suggests that gels like these can be safe to use.

The specific gel being tested, 7-0940, does not contain hormones or steroids, which often results in fewer side effects. Since the trial is in an early stage, safety remains a top priority, and researchers will closely monitor the treatment for any side effects. So far, there have been no reports of negative side effects for this gel, indicating its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gel Dressing 7-0940 is unique because it offers a new approach to treating vulvovaginal atrophy, which is often managed with hormonal therapies or moisturizers. Unlike these standard options, Gel Dressing 7-0940 is a non-hormonal, topical gel that can be applied directly to the affected area, potentially reducing systemic side effects. Researchers are excited because this treatment might provide relief for those who cannot use hormone-based treatments, offering a more accessible and convenient option for managing symptoms.

What evidence suggests that this gel dressing is effective for vulvovaginal atrophy?

Research has shown that the 7-0940 gel dressing, which participants in this trial will receive, effectively improves symptoms such as redness, tissue thinning, and swelling in vulvovaginal atrophy. Studies have also found that it addresses issues like skin breakdown, cracks, sores, scarring, and tissue adhesion. Designed for long-term use, the treatment can maintain these improvements over time. Although the gel dressing is new, these findings suggest it could be a promising option for managing these skin conditions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adult women with vaginal atrophy, lichen sclerosus, lichen simplex chronicus or lichen planus who have ongoing symptoms. Participants need to have access to a smart device and email. Women using recent hormonal therapies, systemic corticosteroids, or those allergic to the gel's ingredients cannot join.

Inclusion Criteria

I have been diagnosed with a specific skin or vaginal condition.

I have a valid email address.

Access to smartphone and tablet, laptop or computer

Exclusion Criteria

I started hormone therapy less than 30 days ago.

Allergy or intolerance to ingredients or excipients of the formulation of studied products

I haven't used topical HRT or corticosteroids for my condition in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel gel dressing to treat vulvovaginal skin conditions

12 months

Monthly follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 7-0940

Trial Overview The VALOR trial is testing a new gel dressing on female adults with certain vulvovaginal conditions. The study aims to evaluate both the immediate and long-term safety and effectiveness of this novel treatment option.

How Is the Trial Designed?

Group I: Feasibility Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stratpharma AG

Lead Sponsor

Trials

12

Recruited

3,000+

Published Research Related to This Trial

The pilot study involving 85 women with severe vulvovaginal atrophy (VVA) showed that treatment with Vaginal Soft gels significantly improved sexual function and vaginal health, particularly in postmenopausal and recurrent vulvovaginitis patients.

The treatment was found to be effective without causing systemic or local side effects, making it a suitable option for patients who cannot use hormonal therapies, although results were less significant in postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis. Maniglio, P., Ricciardi, E., Meli, F., et al.[2020]

In a study involving 80 postmenopausal women, treatment with Hyalo Gyn gel showed significant improvements in various symptoms of vulvovaginal atrophy (VVA) after 3 months, indicating its efficacy.

Hyalo Gyn gel was found to be safe and well tolerated, with no significant difference in perceived improvement compared to a standard water-based lubricant, although a sensitivity analysis favored Hyalo Gyn for dryness reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: a randomized controlled study. Nappi, RE., Kotek, M., Breštánský, A., et al.[2022]

ZP-025 vaginal gel, made from purified bovine colostrum, significantly improved vaginal blood flow and the thickness of the vaginal epithelium in ovariectomized rats, indicating its potential effectiveness for treating vaginal atrophy.

The treatment did not show any systemic side effects, such as changes in body or uterine weights, suggesting that ZP-025 may be a safer alternative to hormone replacement therapy for postmenopausal women experiencing vaginal dryness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effects of a new intravaginal gel, containing purified bovine colostrum, on vaginal blood flow and vaginal atrophy in ovariectomized rat. Vailati, S., Melloni, E., Riscassi, E., et al.[2021]

Both Aqueous Hypromellose-based vaginal gel and oxytocin gel significantly reduced the severity of bothersome vulvovaginal atrophy symptoms over 12 weeks, with no significant difference in effectiveness between the two treatments.

The Aqueous Hypromellose-based vaginal gel was found to be a safe and well-tolerated option, making it an attractive first choice for treating postmenopausal women with vulvovaginal atrophy symptoms, especially since it avoids hormone use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study. Fianu Jonasson, A., Bixo, M., Sundström Poromaa, I., et al.[2022]

In a 12-week study involving 488 postmenopausal women, estradiol gel 0.1% significantly reduced the frequency and severity of vasomotor symptoms, showing effects as early as Week 2 compared to placebo.

All three doses of estradiol gel 0.1% also improved signs of vulvar and vaginal atrophy, making it an effective treatment option with flexible dosing for managing menopause symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Hedrick, RE., Ackerman, RT., Koltun, WD., et al.[2013]

In the 12-week REJOICE trial involving postmenopausal women aged 40-75, TX-004HR significantly improved symptoms of vulvar and vaginal atrophy (VVA), including dyspareunia, with effects observed as early as 2 weeks and maintained through 12 weeks.

The efficacy of TX-004HR was consistent across various subgroups defined by age, body mass index (BMI), uterine status, pregnancy status, and history of vaginal delivery, indicating its broad applicability for treating VVA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women. Constantine, GD., Bouchard, C., Pickar, JH., et al.[2018]

Monurelle Biogel® vaginal gel significantly improved symptoms of vaginal dryness in postmenopausal women after 8 weeks of treatment, with a notable increase in the Verbal Rating Scale (VRS) scores and a clinical success rate of 82.6% in the treatment group compared to 62.8% in the control group.

The gel not only alleviated vaginal dryness but also enhanced vaginal health, as indicated by significant improvements in the Vaginal Health Index (VHI) and Maturation Index (MI), with effects persisting for at least 4 weeks after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monurelle Biogel® vaginal gel in the treatment of vaginal dryness in postmenopausal women. Nappi, RE., Cagnacci, A., Becorpi, AM., et al.[2018]

The study involving 60 postmenopausal women demonstrated that the vaginal gel Meclon Idra significantly reduced symptoms of vulvovaginal atrophy (VVA), such as vaginal dryness and pain, with improvements noted as early as 2 weeks and continuing through the 12-week treatment period.

Meclon Idra also improved sexual function, as indicated by significant increases in scores across all domains of the Female Sexual Function Index, suggesting it is an effective and well-tolerated treatment option for VVA in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study. De Seta, F., Caruso, S., Di Lorenzo, G., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05953090?draw=2&rank=1

NCT05953090 | VALOR: Vaginal Atrophy & Long-term ... It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain ...

2. ctv.veeva.com ctv.veeva.com/study/valor-vaginal-atrophy-long-term-observation-of-recovery

VALOR: Vaginal Atrophy & Long-term Observation of Recovery ... the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9230595/

New Innovations for the Treatment of Vulvovaginal Atrophy The present data suggest great efficacy and safety of a vaginal laser in the treatment of genital symptoms and improvement in sexual function in patients ...

4. researchgate.net researchgate.net/publication/338029752_Local_ultra-low-dose_estriol_gel_treatment_of_vulvo-vaginal_atrophy_efficacy_and_safety_of_long-term_treatment

Local ultra-low-dose estriol gel treatment of vulvo-vaginal ... After 30 weeks, VVA signs significantly improved (p<.01) compared with baseline and first phase results; total objective symptom evaluation ...

5. ctv.veeva.com ctv.veeva.com/study/a-flexible-wound-dressing-for-the-management-of-genital-skin-conditions

a Flexible Wound Dressing for the Management of Genital ... The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients.

6. biorxiv.org biorxiv.org/content/10.1101/2021.08.17.455703v1.full.pdf

Safety and efficacy of a new vaginal gel, Feminilove, for the ... In summary, our results indicate that Feminilove BIO-FRESH moisturizing vaginal gel is a safe and effective remedy for vaginal dryness and ...

7. arts.units.it arts.units.it/retrieve/8945ba6f-0701-4246-b9cd-143dd6ca5862/2987860_1-s2.0-S0378512221000268-main-Post_print.pdf

Efficacy and safety of a new vaginal gel for the treatment of ... Objective: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra ...

8. researchgate.net researchgate.net/publication/349837168_Efficacy_and_safety_of_a_new_vaginal_gel_for_the_treatment_of_symptoms_associated_with_vulvovaginal_atrophy_in_postmenopausal_women_A_double-blind_randomized_placebo-controlled_study

Efficacy and safety of a new vaginal gel for the treatment ... It appears to be a viable option as a local agent for alleviating symptoms of vulvovaginal atrophy (vaginal dryness, itching, and burning feeling) and enhancing ...