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

NCT06144814 | Completed DMC

• 1 other identifier: KoruHealth
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Atrophy

Keywords

vulvovaginal atrophy; Hyaluronic acid; estradiol

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month

Secondary Outcomes (1)

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

  1 month

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

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

Drug: Hyaluronic acid vaginal gel

Estradiol

ACTIVE COMPARATOR

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

Drug: Estrogen vaginal use form

Interventions

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.

Hyaluronic acid

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.

Estradiol

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koru Health Groups: lead

Study Sites (1)

Turkey

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The objective of this randomized controlled trial was to compare the effect of Hyaluronic acid and Estradiol and to determine the effect on VHI. Secondary objective was to investigate the effect of VVA/GSM on symptoms.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: April 5, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

TU (1)