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Status:

COMPLETED

Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause

Lead Sponsor:

HAN Biomedical Inc

Conditions:

Menopause Syndrome

Eligibility:

FEMALE

Phase:

NA

Brief Summary

The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovar...

Detailed Description

It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and...

Eligibility Criteria

Inclusion

  • Subjects who have the relevant syndromes of vulvovaginal atrophy, and who are
  • In the status of menopause (≥12 months after the last menstrual cycle); or
  • FSH \> 40 mIU/ml and estradiol level \< 20 pg/ml; or
  • bilateral ovary resection; or
  • the patients, i.e. breast cancer patients, who completed cancer therapy
  • Subjects have self-identified at least one of mild to moderate or severe symptoms listed below that are the most bothersome to her.
  • Vaginal dryness
  • Vaginal and/or vulvar irritation/itching
  • Dysuria
  • Vaginal pain associated with sexual activity
  • Vaginal bleeding associated with sexual activity
  • Subjects are willing to comply with all aspects of the study and have signed informed consent form.
  • Exclusion Criteria:
  • Subjects have been diagnosed with cervical or vaginal malignant neoplasms
  • Subjects with abnormal undiagnostic genital bleeding
  • Subject with active vaginal infection
  • Subjects with vaginal pH value \< 4.5
  • Subjects are under hormone replacement therapy within three months
  • Subjects are under phytoestrogen treatment within two month
  • Subjects use of vaginal douche, lubricant or moisturizer in one week
  • Subjects are hypersensitive to sodium hyaluronate, carrageenan

Exclusion

    Key Trial Info

    Start Date :

    March 1 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 13 2022

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT05263102

    Start Date

    March 1 2020

    End Date

    August 13 2022

    Last Update

    January 3 2023

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Changhua Christian Hospital

    Changhua, Taiwan

    2

    China Medical University Hospital

    Taichung, Taiwan

    3

    Chi Mei Medical Center

    Tainan, Taiwan

    4

    National Taiwan University Hospital

    Taipei, Taiwan