Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

NCT03557398 | Completed

• 1 other identifier: QQ53-17-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Vulvovaginal Atrophy

Keywords

Hyaluronic acid; Post-menopause

Outcome Measures

Primary Outcomes (1)

• Change of the average score of Vaginal Health Index (VHI)

  Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.

  From baseline to 12 weeks of treatment

Secondary Outcomes (9)

• Change of the average score of Vaginal Health Index (VHI)

  From baseline to 4 weeks of treatment

• Change of vaginal pH

  From baseline to 4 and 12 weeks of treatment

• Change of patient's perception of vulvovaginal symptoms

  From baseline to 4 and 12 weeks of treatment

• Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)

  From baseline to 4 and 12 weeks of treatment

• Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)

  From baseline to 4 and 12 weeks of treatment

Study Arms (1)

Hydeal-D vaginal pessaries

EXPERIMENTAL

Vaginal application of Hydeal-D vaginal pessaries

Device: Hydeal-D vaginal pessaries

Interventions

Hydeal-D vaginal pessaries DEVICE

One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.

Also known as: Hyalogyn vaginal pessaries

Hydeal-D vaginal pessaries

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Selection of post-menopausal women with symptoms of vulvovaginal atrophy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (2)

Gynkomed s.r.o.

Bratislava, 83107, Slovakia

Location

ULMUS, s r.o.

Hlohovec, 920 01, Slovakia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 15, 2018
• Study Start: November 29, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

SL (2)