Vulvovaginal Atrophy Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
| Completed |
NCT03725410 -
Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy
|
N/A | |
| Recruiting |
NCT03823560 -
Performance and Safety of Class IIb MD Celegyn® in VVA
|
N/A | |
| Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
| Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
| Recruiting |
NCT04746456 -
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
|
||
| Completed |
NCT04607798 -
Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
|
N/A | |
| Completed |
NCT04766957 -
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
|
N/A | |
| Completed |
NCT01455597 -
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
|
Phase 3 | |
| Completed |
NCT03557398 -
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
|
N/A | |
| Completed |
NCT03044652 -
Investigation of Non-inferiority of Treatment of Vulvovaginal Dryness With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol
|
Phase 4 | |
| Completed |
NCT03536585 -
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
| Completed |
NCT04629885 -
Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
|
Phase 2 | |
| Recruiting |
NCT04579991 -
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
|
N/A | |
| Recruiting |
NCT05562518 -
GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.
|
Phase 4 | |
| Completed |
NCT02419729 -
Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
|
Phase 3 | |
| Completed |
NCT02085980 -
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
|
N/A | |
| Completed |
NCT01319968 -
Postpartum Dyspareunia Resulting From Vaginal Atrophy
|
N/A | |
| Recruiting |
NCT03782480 -
Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy
|
Phase 3 | |
| Completed |
NCT04887701 -
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
|
N/A |