An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis

Not Applicable

Completed

• Conditions: Atrophic Vaginitis

• Registration Number: NCT05432154
• Lead Sponsor: Stratpharma AG

Brief Summary

The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-27
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Able to provide informed consent
• Diagnosed acute or chronic Atrophic Vaginitis
• Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT

Exclusion Criteria

• Unable to provide informed consent
• Patient unable to apply topical device
• Allergy or intolerance to ingredients or excipients of the formulation of studied products
• Currently on HRT (orally or topically)
• Currently on corticosteroid treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient-reported Vulvar Quality of Life	3 months	Vulvar Quality of Life Index

Secondary Outcome Measures

Name	Time	Method
Severity of overall condition	3 months	Clinician-rated severity of atrophic vaginitis
Patient-reported symptoms	3 months	Likert scales to measure: * Pruritus/itchiness; * Tender/sore; * Swelling; * Dryness; * Burning of skin; * Dyspareunia; * Stinging with urination/clothes; * Defecating pain/burning
Product rating	3 months	Likert scale for product rating by the patient

Trial Locations

Locations (1)

Orange Coast Women's Medical Group; 🇺🇸 Laguna Hills, California, United States