Atrophic VaginitisNCT05432154
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
A study testing Film forming silicone gel (7-0940) in people with Atrophic Vaginitis, run by Stratpharma AG at 1 site in United States.
Trial summary
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- Film forming silicone gel (7-0940)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Coast Women's Medical Group
Laguna Hills, California, 92653
About this study
Official title: Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
- Conditions
- Atrophic Vaginitis
- Being tested
- Film forming silicone gel (7-0940)
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Film forming silicone gel (7-0940)Device
Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas.
Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel.
Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue.
Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients apply 7-0940 at least 2 times daily for 3 months. Receives: Device: Film forming silicone gel (7-0940) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Vulvar Quality of Life
Vulvar Quality of Life Index
Measured: 3 months
Secondary outcomes (3)
Patient-reported symptoms
Likert scales to measure:
- Pruritus/itchiness
- Tender/sore
- Swelling
- Dryness
- Burning of skin
- Dyspareunia
- Stinging with urination/clothes
- Defecating pain/burning
Measured: 3 months
Severity of overall condition
Clinician-rated severity of atrophic vaginitis
Measured: 3 months
Product rating
Likert scale for product rating by the patient
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Apr 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432154
- Sponsor's protocol ID
- SPAMG01
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT05432154
- Acronym / sponsor ID
- SPAMG01
- Conditions
- Atrophic Vaginitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Film forming silicone gel (7-0940)Patients apply 7-0940 at least 2 times daily for 3 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Film forming silicone gel (7-0940)Film forming silicone gel (7-0940) is an innovative gel that forms a full contact, flexible wound dressing for supporting mucosal conditions of the genital, rectal and perineal areas. Film forming silicone gel (7-0940) is a semi-occlusive, non-resorbable, self-drying and transparent gel. Film forming silicone gel (7-0940) may be directly applied to dry, wet, cracked and sensitive mucosal tissue. Film forming silicone gel (7-0940) gel is bacteriostatic and inert. It contains no alcohols, parabens or fragrances. | Device | Treatment arm |
Primary outcome
Patient-reported Vulvar Quality of Life
Time frame: 3 months
Vulvar Quality of Life Index
3 secondary outcomes
Patient-reported symptoms
Time frame: 3 months
Severity of overall condition
Time frame: 3 months
Product rating
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Film forming silicone gel (7-0940) in people with Atrophic Vaginitis, run by Stratpharma AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Vulvar Quality of Life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.