Status:
COMPLETED
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Vulvovaginal Atrophy
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal ...
Eligibility Criteria
Inclusion
- Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
- Women between 18 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 life.
- Patients who give written informed consent to participate in the trial.
Exclusion
- Treatment with another investigational product within the previous 3 months.
- Previous participation in any clinical study with Hydeal-D based investigational products.
- 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); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
- 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.
- Any condition in the investigator's opinion not suitable for the inclusion of the patient.
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04355403
Start Date
February 5 2019
End Date
June 28 2019
Last Update
April 21 2020
Active Locations (2)
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1
Gynkomed s.r.o.
Bratislava, Slovakia, 83107
2
ULMUS, s r.o.
Hlohovec, Slovakia, 920 01