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

NCT ID: NCT06144814

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2023-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Vulvovaginal Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyaluronic acid

The objective of this randomized controlled trial was to compare the effect of Hyaluronic acid and Estradiol and to determine the effect on VHI.

Group Type: EXPERIMENTAL

Hyaluronic acid vaginal gel

Intervention Type: 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.

Estradiol

Secondary objective was to investigate the effect of Hyaluronic acid to VVA/GSM on symptoms.

Group Type: ACTIVE_COMPARATOR

Estrogen vaginal use form

Intervention Type: 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.

Interventions

Hyaluronic acid vaginal gel

. 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.

Intervention Type: DRUG

Estrogen vaginal use form

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Koru Health Groups

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Turkey

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KoruHealth

Identifier Type: -

Identifier Source: org_study_id