Laser Therapy + 7-940 for Vaginal Atrophy

(ASSIST-VLA Trial)

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Stratpharma AG

Must not be taking: Hormonal, Steroidal

Disqualifiers: Allergy, Informed consent, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a daily treatment called 7-940, a new potential drug, can enhance the effects of vaginal laser therapy for women with vaginal atrophy, a condition causing dryness and discomfort. Researchers seek to discover if adding 7-940 after laser sessions is safe and more effective in easing symptoms than laser therapy alone. Women who have already undergone laser treatments and have access to a smartphone or computer may be suitable candidates for this study. As a Phase 4 trial, this research explores how the already FDA-approved treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but if you recently started systemic hormonal or steroidal therapy, you might not be eligible. It's best to discuss your current medications with the trial team.

What is the safety track record for the treatment?

Research has shown that using 7-940 after vaginal laser therapy is safe for patients with vaginal atrophy. Although specific safety data for 7-940 is limited, the study's phase 4 status indicates earlier trials found it well-tolerated. Phase 4 trials typically involve treatments already approved or with strong evidence of safety.

Additionally, fractional CO2 laser therapy, a component of the treatment, has a strong safety record. Studies have demonstrated significant improvement in symptoms like dryness, burning, and itching in post-menopausal women, with a good safety profile. This suggests that combining laser therapy with 7-940 is likely safe, given the proven safety of both components in similar treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for vaginal atrophy focus on hormone replacement therapies, which can have various side effects and aren't suitable for everyone. But 7-940 offers something different. It is combined with laser therapy to potentially enhance tissue regeneration and improve vaginal health without relying on hormones. Researchers are excited about 7-940 because it targets the condition directly, possibly offering a safer and more effective option for those who can't or prefer not to use hormone-based treatments.

What evidence suggests that this treatment might be an effective treatment for vaginal atrophy?

This trial will evaluate the combination of fractional CO2 laser treatments and the investigational treatment 7-940 for vaginal atrophy. Research has shown that fractional CO2 laser treatments effectively reduce symptoms of vaginal atrophy, a condition that causes dryness and irritation. These treatments are safe, well-tolerated, and provide long-lasting relief. The trial uses treatment 7-940 with laser therapy to potentially boost these benefits. Although limited information exists on 7-940, it may help maintain the improvements from laser therapy. Overall, this combination aims to enhance comfort and quality of life for those experiencing vaginal atrophy. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with diagnosed vaginal atrophy who have access to a smart device and email, and have completed laser therapy sessions. It's not specified who can't join the trial.

Inclusion Criteria

I have access to a smartphone, tablet, laptop, or computer.

I have a valid email address.

I have completed all my scheduled laser therapy sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vaginal laser therapy followed by daily 7-0940® treatment to evaluate safety and efficacy

4-6 weeks

Monthly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 7-940

Trial Overview

The study tests the safety and effectiveness of daily treatment with 7-0940® after vaginal laser therapy in patients with vaginal atrophy, using both investigator and patient assessments.

How Is the Trial Designed?

Group I: Safety Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stratpharma AG

Lead Sponsor

Trials

12

Recruited

3,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT07346287

NCT07346287 | ASSIST-VLA: Assessment of Symptom- ...

Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the ...

2.

withpower.com

withpower.com/trial/phase-4-atrophic-vaginitis-7-2025-7bdbd

Laser Therapy + 7-940 for Vaginal Atrophy

The study tests the safety and effectiveness of daily treatment with 7-0940® after vaginal laser therapy in patients with vaginal atrophy, using ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7456654/

Long-Term Safety and Efficacy of Fractional CO2 Laser ...

In conclusion, the results suggest that fractional CO2 laser treatments are safe, well-tolerated and effective in alleviating symptoms of VVA and sexual ...

4.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/energy-based-device-holds-promise-for-patients-with-vaginal-atrophy

Energy-Based Device Holds Promise for Patients with Vaginal ...

“Data has also shown that estrogen cream has high efficacy in this patient population,” she says. “However, there are some patients whose ...

5.

researchgate.net

researchgate.net/publication/334127149_Long-Term_Safety_and_Efficacy_of_Fractional_CO2_Laser_Treatment_in_Post-Menopausal_Women_with_Vaginal_Atrophy_Fractional_CO2_laser_in_Vaginal_atrophy_18m_FU

Fractional CO 2 laser in Vaginal atrophy 18m FU

Almost all VVA symptoms were significantly improved at 12 months following the third treatment compared to Baseline and this improvement was sustained at 15 and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07346287

Study Details | NCT07346287 | ASSIST-VLA: Assessment ...

Study Overview. Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety ...

7.

researchgate.net

researchgate.net/publication/344256407_Long-Term_Safety_and_Efficacy_of_Fractional_CO2_Laser_Treatment_in_Post-Menopausal_Women_with_Vaginal_Atrophy

Long-Term Safety and Efficacy of Fractional CO2 Laser ...

Data indicated a significant improve- ment in VVA symptoms (vaginal dryness, burning, itching and dyspareunia) (P < 0.0001) in patients who ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06900374

Study Details | NCT06900374 | Efficacy and Safety of ...

This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer. The participants ...