Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

Official title

Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.

Overview

The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.

Detailed description

The high prevalence of the Genitourinary Syndrome of the Menopause (GSM) previously known as vulvovaginal atrophy, atrophic vaginitis or urogenital atrophy, does not correlate with the fact that up until today GSM is still hugely underreported, underdiscussed, underdiagnosed as well as undertreated.

Postmenopausal women suffering from symptoms of GSM will be recruited after a routine visit at a Women's Unit at a General Hospital. The participants will self-assess their symptoms with the use of the Day-to-Day impact of Vaginal Aging (DIVA) questionnaire at baseline and after 8 weeks of use of the tested product. Self-assessment with PROMs will allow to obtain a greater knowledge of the physical and emotional state of patients as well as to deliver valuable information to women.

Criteria for a successful outcome will be if the use of the hormone-free agent is well accepted and if symptoms and quality of life improve after 8 weeks of intervention.

Daily dosage of XCMIM20m ((2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid)) will be 2 ml of total product, divided in two applications of 1 ml every 12 hours, preferably morning and bedtime. To be spread topically onto the vulvar area, including the vaginal introitus. The gel will be further applied before sexual intercourse. No intravaginal applicator will be used as the agent will be manually applied directly onto the vulvar area from a 50 ml airless pump dispenser. Four pump applications from the pump dispenser are equivalent to 1ml of tested gel.

Adverse effects, such as allergic reaction, skin irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.

Interventions

• Device Hormone-free vulvovaginal gel with the tested composition XCMIM20m
  Management of GSM in post-menopausal women will be measured with the combination of the application of the hormone-free vulvovaginal gel along the 8 weeks of the study and the use of a PROMs questionnaire. PROMS questionnaire will be delivered to the women at baseline and at the end of the study. Daily living quality of life domains of "activities of daily living", "emotional well-being", "sexual functioning", "self-perception and body image" will be evaluated.

Primary outcome measures

• Changes in GSM symptoms impact on quality of life domains after the intervention [Time frame: Eight weeks of use of the tested product.]

Secondary outcome measures (1)

• Changes in the most affected women's quality of life domain after the intervention [Time frame: Eight weeks of use of the tested product.]

Eligibility criteria

Inclusion criteria

• Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).
• Patient must be postmenopausal with at least 1 year without a menstrual period.
• Patient must consider that her quality of life is affected by GSM symptoms
• Patient not followed due to any gynecological disease.
• All participants must be able to understand and to fill in the self-reported questionnaires.

Exclusion criteria

• Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.
• Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.
• Patients with history of vulvar, vaginal and/or cervical malignancy.
• Patients having received radiotherapy treatment in the pelvic and/or genital region.
• Patients with any type of disease that causes alteration of collagenogenesis.
• Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.
• Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.
• Patients with active urinary and/or genital tract infection.
• Patients with history of malignant neoplasm of the urinary system.
• Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).
• Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.
• Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.
• Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and/or following the established procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Mucosa Innovations S.L. — Madrid

Publications

• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329. PMID 25160739
• Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2. PMID 23985562
• Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281. PMID 24983271
• Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7. PMID 29411644

Identifiers

NCT: NCT06962345 · STOPGSM01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗