The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal DrynessPhase 2NCT01557179
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness
A Phase 2 study testing Hyalofemme and Estriol cream (Ovestin) in people with The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness, run by Lee's Pharmaceutical Limited.
Trial summary
This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
- What is being tested?
- Hyalofemme and Estriol cream (Ovestin)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- May 2009to May 2010
- Phase
- Phase 2
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- under 70 years old,
- had been naturally or surgically postmenopausal for more than 6 months,
- had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen
Who cannot join
- unmarried, pregnant and breast-feeding women,
- patients with vaginal infections such as trichomonas,
- candida and bacterial vaginosis,
- patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
- genital bleeding of unknown origin,
- patients with acute hepatopathy, embolic disorders,
- severe primary disease of the kidney and hematopoietic system
- recent malignant tumors
About this study
Official title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial
This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.
- Being tested
- Hyalofemme, Estriol cream (Ovestin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalofemmeDevice
The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g
Estriol cream (Ovestin)Device
The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid vaginal gel (Hyalofemme) | Experimental | The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g Receives: Device: Hyalofemme |
| Estriol cream (Ovestin) | Active comparator | The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g Receives: Device: Estriol cream (Ovestin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of improvement of vaginal dryness symptoms
percentage of improvement of vaginal dryness symptoms at the baseline and after treatment
Measured: 30 days
Secondary outcomes (1)
percentage of improvement of itching, dyspareunia and burning sensation
percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal DrynessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fidia Farmaceutici s.p.a.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557179
- Sponsor's protocol ID
- LEES_Hyalofemme_1
- Other IDs
- Hyalofemme
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial
- ClinicalTrials.gov ID
- NCT01557179
- Acronym / sponsor ID
- LEES_Hyalofemme_1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Fidia Farmaceutici s.p.a.
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Mar 2012 (estimated)
- 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.
This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid vaginal gel (Hyalofemme) | Experimental | Device: HyalofemmeThe treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g |
| Estriol cream (Ovestin) | Active comparator | Device: Estriol cream (Ovestin)The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- under 70 years old,
- had been naturally or surgically postmenopausal for more than 6 months,
- had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen
Key exclusion criteria (8 listed)
- unmarried, pregnant and breast-feeding women,
- patients with vaginal infections such as trichomonas,
- candida and bacterial vaginosis,
- patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
- genital bleeding of unknown origin,
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 |
|---|---|---|
| HyalofemmeThe treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g | Device | Hyaluronic acid vaginal gel (Hyalofemme) |
| Estriol cream (Ovestin)The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g | Device | Estriol cream (Ovestin) |
Primary outcome
percentage of improvement of vaginal dryness symptoms
Time frame: 30 days
percentage of improvement of vaginal dryness symptoms at the baseline and after treatment
1 secondary outcome
percentage of improvement of itching, dyspareunia and burning sensation
Time frame: 30 days
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 19 Mar 2012.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyalofemme and Estriol cream (Ovestin) in people with The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness, run by Lee's Pharmaceutical Limited.
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 3 inclusion and 8 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percentage of improvement of vaginal dryness symptoms (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2012.