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Performance and Safety of Class IIb MD Celegyn® in VVA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823560
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Evidilya S.r.l.
Information provided by (Responsible Party):
Nathura S.p.A

Brief 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 atrophic vulvovaginitis)

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Device: Celegyn® Device: Matching placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: GROUP A: medical 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
Device: Celegyn®
Medical device Celegyn® presents itself as a cream.

Placebo Comparator: GROUP B: matching placebo

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
Device: Matching placebo
IP placebo presents itself as a cream.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assessment of vulvar signs of VVA assessed by means of vulvoscopy [ Time Frame: from Day 0 to Day 21 ]
    comparison between groups, mean change from Day 0 to Day 21

  2. 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 ]
    comparison between groups, mean change from Day 0 to Day 21

  3. 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 ]
    comparison between groups, mean change from Day 0 to Day 21

  4. 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 ]
    comparison between groups, at Day 21

  5. 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 ]
    comparison between groups, mean change from Day 0 to Day 21

  6. Assessment of global severity score for symptoms of VVA [ Time Frame: from Day 0 to Day 21 ]
    comparison between groups, mean change from Day 0 to Day 21

  7. Assessment of dyspareunia by means of the Marinoff Dyspareunia Scale [ Time Frame: from Day 0 to Day 21 ]
    comparison between groups, mean change from Day 0 to Day 21

  8. Assessment of pain through the short form of McGill Pain questionnaire [ Time Frame: from Day 0 to Day 21 ]
    comparison between groups, mean change from Day 0 to Day 21

  9. Assessment of patient satisfaction, assessed on 0 to 10 points scale (extremely dissatisfied = 0; extremely satisfied = 10) [ Time Frame: at Day 21 ]
    comparison between groups, at Day 21

  10. 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 ]
    comparison between groups, at Day 21

  11. Assessment of rescue product use (starting date and number of times the rescue product was used) [ Time Frame: at Day 21 ]
    comparison among groups, at Day 21



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients aged between 18 and 65 years.
  2. 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).
  3. 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).
  4. Patients agreeing not to use lubricants or other topically applied vaginal products during the study and not to modify their personal hygiene products.
  5. Patients of childbearing potential following a reliable (according to investigator's opinion) non-hormonal contraception therapy.
  6. Patients presenting body mass index between 18.5 and 29.9 kg/m2.
  7. Patients with normal Papanicolaou test results (including inflammatory changes) within the past 12 months after specimen collection.
  8. Willingness to participate in the study and to sign an informed consent form.
  9. No past or present narcotic addiction or alcoholism.

Exclusion Criteria:

  1. Patients presenting vulvar or vaginal pathology other than vulvovaginal atrophy.
  2. Patients pregnant or breastfeeding.
  3. Patients presenting undiagnosed abnormal genital bleeding.
  4. 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.
  5. Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
  6. Patients diagnosed with clinically significant metabolic or endocrine disease or diabetes mellitus uncontrolled by medication.
  7. Patients diagnosed with hypertension and in treatment with antihypertensive medications.
  8. Patients diagnosed with severe renal and/or hepatic insufficiency.
  9. 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)).
  10. Patients on systemic chronic oestrogen - progestin therapy (including contraceptive therapy (pill) or Substitutive Hormonal Therapy (SHT)).
  11. 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.
  12. Patients using topic oestrogen - progestin or hormonal therapy, in the week prior to inclusion.
  13. Patients in treatment with topically applied vaginal products, including medications to promote healing, in the week prior to inclusion.
  14. Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
  15. Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
  16. Smoking patients.
  17. 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.
  18. Patients presenting contraindications to the rescue product, according to concerning Summary of Product Characteristics (SPC).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823560


Contacts
Layout table for location contacts
Contact: Antonio Bertolino, PhD +390249530065 antonio.bertolino@evidilya.com
Contact: Cesare Mutti +390249530065 cesare.mutti@evidilya.com

Locations
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Italy
Spedali Civili di Brescia Not yet recruiting
Brescia, Italy, 25123
Contact: Franco Odicino, Prof    +390303995341    franco.odicino@unibs.it   
Istituto Europeo di Oncologia Recruiting
Milan, Italy, 20141
Contact: Eleonora P Preti, MD    +390257489616    eleonora.preti@ieo.it   
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Rossella E Nappi, Prof       r.nappi@smatteo.pv.it   
Sponsors and Collaborators
Nathura S.p.A
Evidilya S.r.l.
Layout table for additonal information
Responsible Party: Nathura S.p.A
ClinicalTrials.gov Identifier: NCT03823560    
Other Study ID Numbers: CeleMD01
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrophy
Pathological Conditions, Anatomical