Vulvovaginal AtrophyNCT06144814
A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.
A study testing Hyaluronic acid vaginal gel and Estrogen vaginal use form in people with Vulvovaginal Atrophy, run by Koru Health Groups at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Hyaluronic acid vaginal gel and Estrogen vaginal use form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Hyaluronic acid vaginal gel, Estrogen vaginal use form
- Keywords
- vulvovaginal atrophy, Hyaluronic acid, estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid vaginal gelDrug
. 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 formDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hyaluronic acid vaginal gel |
| Estradiol | Active comparator | Secondary objective was to investigate the effect of Hyaluronic acid to VVA/GSM on symptoms. Receives: Drug: Estrogen vaginal use form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start5 Apr 2023
- Primary completion15 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koru Health Groups
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144814
- Sponsor's protocol ID
- KoruHealth
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jafarzade A, Mungan T, Aghayeva S, Yildirim Baydemir B, Ekiz OU, Biri A. A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy. Eur Rev Med Pharmacol Sci. 2024 Jan;28(2):571-576. doi: 10.26355/eurrev_202401_35054.
PubMed 38305601
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.
- ClinicalTrials.gov ID
- NCT06144814
- Acronym / sponsor ID
- KoruHealth
- Conditions
- Vulvovaginal Atrophy
- Keywords
- vulvovaginal atrophy, Hyaluronic acid, estradiol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Koru Health GroupsUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Drug: Hyaluronic acid vaginal gelThe objective of this randomized controlled trial was to compare the effect of Hyaluronic acid and Estradiol and to determine the effect on VHI. |
| Estradiol | Active comparator | Drug: Estrogen vaginal use formSecondary objective was to investigate the effect of Hyaluronic acid to VVA/GSM on symptoms. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Hyaluronic acid |
| Estrogen vaginal use formGroup I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks. | Drug | Estradiol |
Primary outcome
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.
1 secondary outcome
A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 38305601Jafarzade A, Mungan T, Aghayeva S, Yildirim Baydemir B, Ekiz OU, Biri A. A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy. Eur Rev Med Pharmacol Sci. 2024 Jan;28(2):571-576. doi: 10.26355/eurrev_202401_35054.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid vaginal gel and Estrogen vaginal use form in people with Vulvovaginal Atrophy, run by Koru Health Groups at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of hyaluronic acid and estradiol treatment in vulvovaginal atrophy. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.