Vaginal DrynessPhase 4GYNOMUNAL®NCT01948583
Humectant Activity of a New Formulation of Gynomunal® Vaginalgel
A Phase 4 study testing Hyaluronic Acid in people with Vaginal Dryness and Menopause, run by Derming SRL at 1 site in Italy.
Trial summary
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Dryness, Menopause
- What is being tested?
- Hyaluronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Caucasian healthy female subjects,
- complaining vaginal dryness,
- women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place,
- women who agree not to start a replacement therapy during the whole duration of the study,
- women who do not present any active cutaneous pathology of external and internal genitalia,
- women who did not receive any drug or cosmetic treatment on their genitalia during the 2 months preceding the trial,
Show all 12Show fewer
- women who did not apply vaginal products within at least 1 month before the inclusion in the study,
- women who accept to use only the products authorised by the protocol,
- women who accept not to undertake any treatment for internal and external genitalia during the trial,
- women who did not use, phytoestrogenes based products on treated areas less than 4 weeks before inclusion time,
- women accepting to sign the Informed consent form,
- women able to read the material dedicated to volunteers, to abide by the rules of the protocol and ready to accept its constraints
Who cannot join
- Volunteers not fulfilling inclusion criteria,
- severe symptoms of vaginal dryness, associated with mucosal signs
- history of intolerance to a vaginal product,
- concomitant participation to another trial,
- refusal to sign the Informed Consent form,
- known allergy to one or several ingredients of the product on trial,
Show all 11Show fewer
- change in the normal habits in the last 3 months,
- participation in a similar study during the previous 3 months,
- whose insufficient adhesion to the study protocol is foreseeable
- women who start a replacement therapy during the trial
- women who experience during the study the occurrence of any foreseeable risk to use daily the product on trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness
Read the detailed description
Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.
Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).
Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.
- Conditions
- Vaginal Dryness, Menopause
- Being tested
- Hyaluronic Acid
- Keywords
- vaginal dryness, hyaluronic acid, menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called Gynomunal® Vaginalgel (GYNOMUNAL®)
Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period)
| Study group | Role | What they receive |
|---|---|---|
| Arm I: vaginal gel new formulation | Active comparator | Application once a day at evening during the first study week of the vaginal gel new formulation (hyaluronic acid).
One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal gel on the market (hyaluronic acid). Receives: Drug: Hyaluronic Acid |
| Arm II: vaginal gel on the market | Active comparator | Application once a day at evening during the first study week of the vaginal gel on the market (hyaluronic acid).
One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal new formulation (hyluronic acid). Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Humidity determination
Measured: 2 weeks
Secondary outcomes (1)
Tolerability assessment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
- Investigators
- Adele Sparavigna, Physician, Principal investigator, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948583
- Sponsor's protocol ID
- E0513
- Acronym
- GYNOMUNAL®
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
- ClinicalTrials.gov ID
- NCT01948583
- Acronym / sponsor ID
- GYNOMUNAL® / E0513
- Conditions
- Vaginal Dryness, Menopause
- Keywords
- vaginal dryness, hyaluronic acid, menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Sep 2013 (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.
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness
Detailed description
Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.
Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).
Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: vaginal gel new formulation | Active comparator | Drug: Hyaluronic AcidApplication once a day at evening during the first study week of the vaginal gel new formulation (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal gel on the market (hyaluronic acid). |
| Arm II: vaginal gel on the market | Active comparator | Drug: Hyaluronic AcidApplication once a day at evening during the first study week of the vaginal gel on the market (hyaluronic acid). One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal new formulation (hyluronic acid). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Caucasian healthy female subjects,
- complaining vaginal dryness,
- women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place,
- women who agree not to start a replacement therapy during the whole duration of the study,
- women who do not present any active cutaneous pathology of external and internal genitalia,
Key exclusion criteria (11 listed)
- Volunteers not fulfilling inclusion criteria,
- severe symptoms of vaginal dryness, associated with mucosal signs
- history of intolerance to a vaginal product,
- concomitant participation to another trial,
- refusal to sign the Informed Consent form,
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 AcidAlso: Gynomunal® Vaginalgel (GYNOMUNAL®)Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period) | Drug | Arm I: vaginal gel new formulation, Arm II: vaginal gel on the market |
Primary outcome
Vaginal Humidity determination
Time frame: 2 weeks
1 secondary outcome
Tolerability assessment
Time frame: 2 weeks
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 23 Sep 2013.
Related trials for Vaginal Dryness
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Recruiting
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Vaginal Dryness, Menopause Symptoms
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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.
Adele Sparavigna, Physician principal investigator
Derming SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic Acid in people with Vaginal Dryness and Menopause, run by Derming SRL at 1 site in Italy.
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 12 inclusion and 11 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 23 Sep 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Vaginal Humidity determination (time frame: 2 weeks). 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 23 Sep 2013.