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OpenTrials
Completed

NCT Number: NCT02014428

Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

Completed

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Key information

Conditions

Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.

Messina, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 12 months postmenopausal
  • mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

Treatment and study plan

Hyaluronic acid

Dietary Supplement

Placebo

Drug

Primary outcomes

  1. Atrophic vaginal changes

    Time frame: Change from baseline epithelium at 3 months

    Morphometric analysis of biopsies.

Secondary outcomes

  1. Assessment of Itching

    Time frame: Change from baseline Itching at 3 months

    Scale: absent, mild, moderate, severe.

  2. Assessment of Burning

    Time frame: Change from baseline Burning at 3 months

    Scale: absent, mild, moderate, severe.

  3. Assessment of Dyspareunia

    Time frame: Change from baseline Dyspareunia at 3 months

    Scale: absent, mild, moderate, severe.

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

Primary completion
2013
First posted
Dec 18, 2013
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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