Atrophic VaginitisVALORNCT05953090
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
A study testing 7-0940 in people with Atrophic Vaginitis and Vaginal Atrophy, run by Stratpharma AG at 14 sites in United States.
Trial summary
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause
- What is being tested?
- 7-0940
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 14 sitesUnited States
- Study dates
- 30 Oct 2023to Dec 2028
- Phase
- Interventional
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
- Continuous vulvovaginal symptoms
- Access to smartphone and tablet, laptop or computer
- Access to a valid email address
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
- Systemic hormonal therapy started less than 30 days before baseline
- Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline
- Ongoing topical HRT or corticosteroid treatment for the indication under investigation
- Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama, 35244
Jennifer Perry, 205 778-1564, jperry@cahabaderm.com
- Recruiting
Velvet Clinical Research
Burbank, California, 91506
Monica Torres, 323-527-0907, mtorres@velvetclinicalresearch.com
- Not yet recruiting
WR-Charleston Clinical Trials, LLC
Charleston, South Carolina, 29414
Vanessa Armetta, (843)-405-9834, varmetta@wakeresearch.com
Donald Hurley, DO
- Recruiting
WR-Global Medical Research, LLC
Dallas, Texas, 75224
Vicki Martinez, (469) 297-3074, vmartinez@wakeresearch.com
Roxanne Pero, MD
- Recruiting
WR-Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303
Caitlyn Miller, (910) 302-8151, cmiller@wakeresearch.com
Connette McMahon, MD
- Active, not recruiting
Orange Coast Women's Medical Group
Laguna Hills, California, 92653
- Not yet recruiting
WR-Multi-Specialty Research Associates
Lake City, Florida, 32055
Wanda North, (386)-438-8977, wnorth@msrainc.com
Cynthia Magrini, MD
- Not yet recruiting
WR-Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89106
Melissa Ellis, (702) 893-8968, mellis@crcnnv.com
Liliana Ruiz-Leon, DO
- Not yet recruiting
WR-PRI, LLC (Los Alamitos)
Los Alamitos, California, 90720
Linette Chhin, (714) 827-3668, lchhin@wakeresearch.com
Yasmin Herring, MD
- Not yet recruiting
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38210
Laurie Miles, (901) 507-1049, lmiles@wakeresearch.com
Todd Chappell, MD
- Recruiting
WR-PRI, LLC (Newport Beach)
Newport Beach, California, 92660
Diana Nguyen, (949) 752-7910, dnguyen@wakeresearch.com
Susan Park, MD
- Not yet recruiting
WR-Women's Health Care Research, LLC
San Diego, California, 92111
Cynthia Ho, (858) 505-8672, cho@wakeresearch.com
Robert Semo, MD
- Not yet recruiting
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Kim Williams, (404) 843-4410, kwilliams@wakeresearch.com
Gretchen Mitchell, MD
- Recruiting
Southern Urogynecology
West Columbia, South Carolina, 29169
Tina McGready, 803-457-7000, tmcgready@southurogyn.com
Andrea Pezzella, MD
About this study
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting 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.
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva, Lichen Planus of Vulva, Lichen Simplex of Vulva (Disorder)
- Being tested
- 7-0940
- Medical subject headings
- Atrophic Vaginitis, Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-0940Device
Also called StrataMGT
A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility | Experimental | Not described Receives: Device: 7-0940 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvovaginal Symptoms Questionnaire (VSQ) [min:0; max:16 (for sexually inactive patients) / max: 20 (for sexually active patients)]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VSQ score at 12 months.
Measured: 12 months
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months
The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). [min:0; max:45]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VQLI score at 12 months.
Measured: 12 months
Secondary outcomes (6)
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
Measured: 12 months
Change in patient-rated symptom severity assessed using a 10-point Likert scale.
Severity of symptoms (itch, burning, pain, irritation, dryness and pain during intercourse) are rated by the patient at baseline and at 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
Measured: 12 months
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
Severity of the visual pathology is rated by the investigator during baseline and after 12 months, using a 10-point Likert scale, ranging from 0=normal to 10=worst possible. Overall visual severity may include the severity of pathology at the Clitoral Hood, Urethra Area, Vaginal Vault, Labia Majora / Minora, Fourchette, Perineum, Perianal skin, Extragential site and/or Inguinal folds.
Measured: 12 months
Adverse Reactions
Adverse reactions are rated by the investigator during baseline and after months 3, 6, 9, 12 months, using the dichotomous scale of presence and absence.
Measured: 12 months
Product rating
Product performance is rated by the patient at the final visit after 12 months, using a Likert scale from 1=unsatisfactory to 5=excellent.
Measured: 12 months
Treatment adherence
Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start30 Oct 2023
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953090
- Sponsor's protocol ID
- SPAMG03
- Acronym
- VALOR
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes