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Completed

NCT Number: NCT06144814

A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.

The goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.Hyaluronic acid and Estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or who wish to receive non-hormonal therapy.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turkey

Ankara, Çankaya, 06530, Turkey (Türkiye)

About this study

This randomized, controlled, monocentric, prospective, comparative (before/after) study was conducted at Koru Ankara Hospital between April 2023 and September 2023. Patients were randomized into 2 groups. A total of 300 patients, 150 in each group, were included in the study. Informed written consent was obtained from the volunteers who willingly participated in the study. Group I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks. Group II received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. Hyaluronic acid gel for vaginal use was supplied by ORTHOGEN®. The treatment period lasted 1 month in both groups.

Before receiving treatment, patients who consented to participate in the study were examined by a Gynecologist, and Vaginal Health Index (VHI)12 score was determined. After the end of the treatment period, the patients were re-evaluated by the same physician, and the VHI score was obtained again. The VHI is the most common score based on vaginal elasticity, secretions, pH, presence of petechiae on the epithelial mucosa, and hydration assessment. The score can range from 5 to 25, and <15 is considered an atrophic vagina index.

Vaginal pH was measured by placing pH paper on the anterior wall of the vagina. A value >5 pH was defined as decreased estrogen activity13. The effect on the primary outcome VHI index was investigated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 40 years, FSH value above 25 pg/ml, LH value above 20 pg/ml, E2 value below 15 pg/ml, endometrial thickness of 5 mm or less, and absence of menstruation for 12 months.

Exclusion criteria

  • patients receiving Hormone Replacement Therapy (HRT), genital organ malignancy, breast cancer, patients with vaginal bleeding of unknown cause, history of thrombophlebitis and thromboembolism, thrombophilia, acute or chronic cardiovascular diseases, estrogen and hyaluronic acid allergy, vaginal infection, acute or chronic cardiovascular diseases, and liver diseases. Patients eligible to participate in the study were required to report at least one of the following symptoms: vaginal dryness, burning or irritation, lack of lubrication during intercourse, sexual discomfort or pain during intercourse, dysuria, or recurrent urinary tract infection.

Treatment and study plan

Hyaluronic acid vaginal gel

Drug

. Group II received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. Hyaluronic acid gel for vaginal use was supplied by ORTHOGEN®. The treatment period lasted 1 month in both groups.

Estrogen vaginal use form

Drug

Group I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks.

Primary outcomes

  1. A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy.

    Time frame: 1 month

    Before receiving treatment, patients who consented to participate in the study were examined by a Gynecologist, and Vaginal Health Index (VHI) score was determined. After the end of the treatment period, the patients were re-evaluated by the same physician, and the VHI score was obtained again. The VHI is the most common score based on vaginal elasticity, secretions, pH, presence of petechiae on the epithelial mucosa, and hydration assessment. The score can range from 5 to 25, and <15 is considered an atrophic vagina index.

Secondary outcomes

  1. A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy.

    Time frame: 1 month

    Vaginal pH was measured by placing pH paper on the anterior wall of the vagina. A value >5 pH was defined as decreased estrogen activity. The effect on the primary outcome VHI index was investigated

Sponsors and collaborators

Lead sponsor

Koru Health Groups

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

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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