Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 1592 for:    Slovakia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03557398
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Fidia Farmaceutici s.p.a.

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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Device: Hydeal-D vaginal pessaries Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Hydeal-D vaginal pessaries
Vaginal application of Hydeal-D vaginal pessaries
Device: Hydeal-D vaginal pessaries
One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
Other Name: Hyalogyn vaginal pessaries




Primary Outcome Measures :
  1. Change of the average score of Vaginal Health Index (VHI) [ Time Frame: From baseline to 12 weeks of treatment ]
    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.


Secondary Outcome Measures :
  1. Change of the average score of Vaginal Health Index (VHI) [ Time Frame: From baseline to 4 weeks of treatment ]
    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.

  2. Change of vaginal pH [ Time Frame: From baseline to 4 and 12 weeks of treatment ]
    The pH values are grouped on a four-point scale and scored respectively: pH lower than 5 = 0; pH between 5 and 5.49 = 1; pH between 5.5 and 6.49 = 2; pH higher than 6.49 =3.

  3. Change of patient's perception of vulvovaginal symptoms [ Time Frame: From baseline to 4 and 12 weeks of treatment ]
    Symptoms associated with vulvovaginal atrophy (dryness, irritation/itching, soreness, dysuria, dyspareunia) are reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).

  4. Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI) [ Time Frame: From baseline to 4 and 12 weeks of treatment ]
    Female Sexual Function Index (FSFI) questionnaire consists of six domains - desire (two items), arousal (four items), lubrication (four items), orgasm (three items), satisfaction (three items), and pain (three items) - answered on a five-point Likert scale (0, no sexual activity; 1, never/very low; 5, always/very high). A score is calculated for each of the six domains, and the total score is obtained by summing all of the items. Total score ranges from 2 to 36. A lower score corresponds to a greater sexual dysfunction.

  5. Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R) [ Time Frame: From baseline to 4 and 12 weeks of treatment ]
    Female Sexual Distress Scale-Revised (FSDS-R) questionnaire consists of 13 items scored on a five-point scale (0, never; 1, rarely; 2, occasionally; 2, frequently; 4, always). The total score is obtained by summing all of the items. Total score ranges from 0 to 52. A higher score corresponds to a greater sexual dysfunction.

  6. Amelioration of the vaginal maturation (VM) index [ Time Frame: From baseline to 12 weeks of treatment ]
    Vaginal maturation (VM) index is calculated quantifying the percentages of parabasal, intermediate, and superficial cells. The following formula is used: VMI = [1(% superficial cells)] + [0.6(% intermediate cells)] + [0.2(% parabasal cells)]. The index ranges from 0% to 100%.The higher the maturation index, the higher the number of mature cells (0%-49%, low stimulation of the vaginal epithelium; 50%-64%, moderate stimulation of the vaginal epithelium; 65%-100%, high stimulation of the vaginal epithelium).

  7. Patient's global assessment of overall satisfaction [ Time Frame: 4 and 12 weeks of treatment ]
    Patient's global assessment (PTGA) is evaluated as the patient's overall satisfaction of the treatment scored on a four grade scale, ranging from 0 to 3 (0= dissatisfied or very dissatisfied, 1= moderately satisfied or satisfied, 2= very satisfied and 3= greatly satisfied). A higher score corresponds to a greater satisfaction.

  8. Local tolerability at the application site [ Time Frame: 4 and 12 weeks of treatment ]
    Local tolerability of the product at the application site is evaluated by both the clinician and the patient independently, through a 5-point scale, ranging from 0 to 5 (1 = excellent (no reaction), 2 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 4 = poor (reaction needing interruption of treatment), 5 = bad (serious reaction)). A higher score corresponds to a better tolerability.

  9. Safety of the treatment: Collection of adverse events [ Time Frame: 4 and 12 weeks of treatment ]
    Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Selection of post-menopausal women with symptoms of vulvovaginal atrophy
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557398


Locations
Layout table for location information
Slovakia
Gynkomed s.r.o.
Bratislava, Slovakia, 83107
ULMUS, s r.o.
Hlohovec, Slovakia, 920 01
Sponsors and Collaborators
Fidia Farmaceutici s.p.a.

Layout table for additonal information
Responsible Party: Fidia Farmaceutici s.p.a.
ClinicalTrials.gov Identifier: NCT03557398     History of Changes
Other Study ID Numbers: QQ53-17-01
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fidia Farmaceutici s.p.a.:
Hyaluronic acid
Post-menopause

Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Pathological Conditions, Anatomical