Clinical trial NCT03557398: Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Official title: Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Keywords: Hyaluronic acid
Post-menopause
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L, or had been surgically postmenopausal for more than 6 months)
* Women between 45 and 75 years of age.
* Vaginal pH ≥5
* Vulvovaginal atrophy with VHI \< 15
* At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
* Women with active sex lives
* Patients who give written informed consent to participate in the trial

Exclusion Criteria:

* Enrollment in other clinical trials within the previous 1 month.
* Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
* Patients in previous treatment with either oral or topical hormonal products within 1 month.
* Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
* Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
* Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
* Women with no active sex lives
* Women who do not give informed consent;
* Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient

Primary outcomes:
measure: Change of the average score of Vaginal Health Index (VHI)
timeFrame: From baseline to 12 weeks of treatment
Secondary outcomes:
measure: Change of the average score of Vaginal Health Index (VHI)
timeFrame: From baseline to 4 weeks of treatment
measure: Change of vaginal pH
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Change of patient's perception of vulvovaginal symptoms
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Amelioration of the vaginal maturation (VM) index
timeFrame: From baseline to 12 weeks of treatment
measure: Patient's global assessment of overall satisfaction
timeFrame: 4 and 12 weeks of treatment
measure: Local tolerability at the application site
timeFrame: 4 and 12 weeks of treatment
measure: Safety of the treatment: Collection of adverse events
timeFrame: 4 and 12 weeks of treatment
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Gynkomed s.r.o.
city: Hlohovec
country: Slovakia
facility: ULMUS, s r.o.
Study officials:
References: