Vulvovaginal AtrophyNCT03823560
Performance and Safety of Class IIb MD Celegyn® in VVA
A study testing Celegyn® in people with Vulvovaginal Atrophy, run by Nathura S.p.A at 3 sites in Italy.
Trial summary
The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Celegyn®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 3 sitesItaly
- Study dates
- 24 Sep 2019to Sep 2021
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 65 years.
- Patients reporting vulvovaginal dryness associated with spontaneous pain and / or dyspareunia (minimum score of 30 on a 100 mm Visual Analogue Scale for both symptoms referable to vulvovaginal atrophy: dryness and spontaneous pain and / or dyspareunia).
- Patients sexually active (i.e. women who currently have intercourse or other sexual activity (masturbation, etc) at least once a month (with or without a partner), or who had intercourse or other sexual activity at least once a month in the past, but later decreased sexual activity due to excessive pain or vaginal dryness. Dyspareunia is defined (2nd International Consultation on Sexual Medicine) as "persistent or recurrent pain with attempted or complete vaginal entry and/or penile vaginal intercourse" that is not the result of other abnormalities).
- Patients agreeing not to use lubricants or other topically applied vaginal products during the study and not to modify their personal hygiene products.
- Patients of childbearing potential following a reliable (according to investigator's opinion) non-hormonal contraception therapy.
- Patients presenting body mass index between 18.5 and 29.9 kg/m2.
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- Patients with normal Papanicolaou test results (including inflammatory changes) within the past 12 months after specimen collection.
- Willingness to participate in the study and to sign an informed consent form.
- No past or present narcotic addiction or alcoholism.
Who cannot join
- Patients presenting vulvar or vaginal pathology other than vulvovaginal atrophy.
- Patients pregnant or breastfeeding.
- Patients presenting undiagnosed abnormal genital bleeding.
- Patients presenting endometrial pathology, such as hyperplasia (endometriosis) or endometrial polyps, cancer, palpable fibroids or grade 2 uterine prolapse (when the cervix reaches the labia minora) on gynaecologic examination.
- Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
- Patients diagnosed with clinically significant metabolic or endocrine disease or diabetes mellitus uncontrolled by medication.
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- Patients diagnosed with hypertension and in treatment with antihypertensive medications.
- Patients diagnosed with severe renal and/or hepatic insufficiency.
- Patients who have changed or started systemic oestrogen - progestin or hormone therapy in the 3 months prior to inclusion (including contraceptive therapy (pill) or Substitutive Hormonal Therapy (SHT)).
- Patients on systemic chronic oestrogen - progestin therapy (including contraceptive therapy (pill) or Substitutive Hormonal Therapy (SHT)).
- Patients in treatment with the following systemic drug: nonsteroidal anti-inflammatory drugs, antihistamines, corticosteroids in the 2 weeks prior to inclusion, immunosuppressants in the 3 months prior to inclusion, venotonic or diuretic agents in the month prior to inclusion.
- Patients using topic oestrogen - progestin or hormonal therapy, in the week prior to inclusion.
- Patients in treatment with topically applied vaginal products, including medications to promote healing, in the week prior to inclusion.
- Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
- Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
- Smoking patients.
- Patients who in the opinion of the principal investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
- Patients presenting contraindications to the rescue product, according to concerning Summary of Product Characteristics (SPC).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Not yet recruiting
Spedali Civili di Brescia
Brescia, 25123
Franco Odicino, Prof, +390303995341, franco.odicino@unibs.it
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Eleonora P Preti, MD, +390257489616, eleonora.preti@ieo.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Rossella E Nappi, Prof, r.nappi@smatteo.pv.it
About this study
Official title: Evaluation of Performance and Safety of the CE Marked Medical Device Class IIb Celegyn® in Vulvovaginal Atrophy (VVA): a Randomised, Double-blind, Parallel Groups, Multicentric, Placebo-Controlled, Prospective Clinical Study
The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Celegyn®, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celegyn®Device
Medical device Celegyn® presents itself as a cream.
Matching placeboDevice
IP placebo presents itself as a cream.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A: medical device Celegyn® | Experimental | Medical device Celegyn® presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
* for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;
* for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert Receives: Device: Celegyn® |
| GROUP B: matching placebo | Placebo comparator | Investigational Product (IP) placebo presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use.
Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following:
* for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage;
* for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert Receives: Device: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Vaginal Health Index (VHI)
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Secondary outcomes (11)
Assessment of vulvar signs of VVA assessed by means of vulvoscopy
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively)
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6)
comparison between groups, at Day 21
Measured: at Day 21
Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to 21
Assessment of global severity score for symptoms of VVA
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment of pain through the short form of McGill Pain questionnaire
comparison between groups, mean change from Day 0 to Day 21
Measured: from Day 0 to Day 21
Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10)
comparison between groups, at Day 21
Measured: at Day 21
Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4)
comparison between groups, at Day 21
Measured: at Day 21
Assessment of rescue product use (starting date and number of times the rescue product was used)
comparison among groups, at Day 21
Measured: at Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start24 Sep 2019
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathura S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823560
- Sponsor's protocol ID
- CeleMD01
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety of the CE Marked Medical Device Class IIb Celegyn® in Vulvovaginal Atrophy (VVA): a Randomised, Double-blind, Parallel Groups, Multicentric, Placebo-Controlled, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT03823560
- Acronym / sponsor ID
- CeleMD01
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Nathura S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 30 Jan 2019 (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 aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study
| Arm | Type | Receives |
|---|---|---|
| GROUP A: medical device Celegyn® | Experimental | Device: Celegyn®Medical device Celegyn® presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use. Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following: * for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage; * for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert |
| GROUP B: matching placebo | Placebo comparator | Device: Matching placeboInvestigational Product (IP) placebo presents itself as a white ivory cream (cream-like oil-in-water topical emulsion) with a typical smell; it is intended for topical use. Posology: It is to be applied preferably in the evening, once a day, for the first seven days, and every other day until the end of the study (i.e. during the second and third week) according to the following: * for external (vulvar) use: it should be applied as needed directly to the affected area with a gentle massage; * for internal (vaginal) use: use the vaginal applicators provided and follow the directions of use, according to package insert |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients aged between 18 and 65 years.
- Patients reporting vulvovaginal dryness associated with spontaneous pain and / or dyspareunia (minimum score of 30 on a 100 mm Visual Analogue Scale for both symptoms referable to vulvovaginal atrophy: dryness and spontaneous pain and / or dyspareunia).
- Patients sexually active (i.e. women who currently have intercourse or other sexual activity (masturbation, etc) at least once a month (with or without a partner), or who had intercourse or other sexual activity at least once a month in the past, but later decreased sexual activity due to excessive pain or vaginal dryness. Dyspareunia is defined (2nd International Consultation on Sexual Medicine) as "persistent or recurrent pain with attempted or complete vaginal entry and/or penile vaginal intercourse" that is not the result of other abnormalities).
- Patients agreeing not to use lubricants or other topically applied vaginal products during the study and not to modify their personal hygiene products.
- Patients of childbearing potential following a reliable (according to investigator's opinion) non-hormonal contraception therapy.
Key exclusion criteria (18 listed)
- Patients presenting vulvar or vaginal pathology other than vulvovaginal atrophy.
- Patients pregnant or breastfeeding.
- Patients presenting undiagnosed abnormal genital bleeding.
- Patients presenting endometrial pathology, such as hyperplasia (endometriosis) or endometrial polyps, cancer, palpable fibroids or grade 2 uterine prolapse (when the cervix reaches the labia minora) on gynaecologic examination.
- Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
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 |
|---|---|---|
| Celegyn®Medical device Celegyn® presents itself as a cream. | Device | GROUP A: medical device Celegyn® |
| Matching placeboIP placebo presents itself as a cream. | Device | GROUP B: matching placebo |
Primary outcome
Assessment of Vaginal Health Index (VHI)
Time frame: from Day 0 to Day 21
comparison between groups, mean change from Day 0 to Day 21
11 secondary outcomes
Assessment of vulvar signs of VVA assessed by means of vulvoscopy
Time frame: from Day 0 to Day 21
Assessment of vulvar signs of VVA (vaginal secretions, vaginal epithelial integrity, vaginal epithelial surface thickness and vaginal colour, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively)
Time frame: from Day 0 to Day 21
Assessment of visible skin signs of irritation such as redness, dryness, scaling, peeling, bumps, hives, categorized as none, mild, moderate, or severe corresponding to a score of 0, 1, 2 or 3, respectively
Time frame: from Day 0 to Day 21
Assessment done by Investigator of overall improvement by means of Global Assessment of Improvement (GAI - according to a 7-grade scoring system, 0-6)
Time frame: at Day 21
Assessment of subjective vaginal symptoms related to VVA and irritation (dryness, dyspareunia, burning, itching, stinging) by means of 100 mm Visual Analogue Scales
Time frame: from Day 0 to 21
Assessment of global severity score for symptoms of VVA
Time frame: from Day 0 to Day 21
Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale
Time frame: from Day 0 to Day 21
Assessment of pain through the short form of McGill Pain questionnaire
Time frame: from Day 0 to Day 21
Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10)
Time frame: at Day 21
Patient willingness to use the product in the future, assessed on 1 - 4 points scale (strongly disagree=1, disagree=2, agree=3, strongly agree=4)
Time frame: at Day 21
Assessment of rescue product use (starting date and number of times the rescue product was used)
Time frame: at Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celegyn® in people with Vulvovaginal Atrophy, run by Nathura S.p.A at 3 sites 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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Bertolino, PhD (+390249530065, antonio.bertolino@evidilya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Vaginal Health Index (VHI) (time frame: from Day 0 to Day 21). 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 6 Jan 2021.