An interventional study of Film forming silicone gel (7-0940) in Atrophic Vaginitis, sponsored by Stratpharma AG. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Stratpharma AG · Not applicable, Interventional, and Treatment
Among 23 studies in Atrophic Vaginitis with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Atrophic Vaginitis · United States.
Among the 23 studies in Atrophic Vaginitis with a site in United States, this one is the 23rd largest by enrollment, is the only one that started in 2022, is one of 4 with no phase, and was the 20th registered.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 10 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →2 of the 23 studies in Atrophic Vaginitis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 4 Atrophic Vaginitis studies recruiting now, 3 (75%) set no upper age limit and 1 (25%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2022.
Median enrollment 69 across the 23 interventional studies. Of the 21 that completed or were terminated, 12 (57%) have results posted.
15 of 23 have an industry lead sponsor. The 10 most frequent:
Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Stratpharma AG has 4 studies filed under Atrophic Vaginitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Atrophic Vaginitis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients apply 7-0940 at least 2 times daily for 3 months.
Device: 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.
Patient-reported Vulvar Quality of Life
Vulvar Quality of Life Index
Time frame: 3 months
Patient-reported symptoms
Likert scales to measure: * Pruritus/itchiness * Tender/sore * Swelling * Dryness * Burning of skin * Dyspareunia * Stinging with urination/clothes * Defecating pain/burning
Time frame: 3 months
Severity of overall condition
Clinician-rated severity of atrophic vaginitis
Time frame: 3 months
Product rating
Likert scale for product rating by the patient
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Jul 2022, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Stratpharma AG