Performance and Safety of Class IIb MD Celegyn® in VVA

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)

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Device: Celegyn®; Device: Matching placebo

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Bertolino, PhD; Phone Number: +390249530065; Email: antonio.bertolino@evidilya.com
• Study Contact Backup: Name: Cesare Mutti; Phone Number: +390249530065; Email: cesare.mutti@evidilya.com

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Not yet recruiting
    • Spedali Civili di Brescia
    • Contact: Franco Odicino, Prof; Phone Number: +390303995341; Email: franco.odicino@unibs.it
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo di Oncologia
    • Contact: Eleonora P Preti, MD; Phone Number: +390257489616; Email: eleonora.preti@ieo.it
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Rossella E Nappi, Prof; Email: r.nappi@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Vaginal Health Index (VHI)	comparison between groups, mean change from Day 0 to Day 21	from Day 0 to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of vulvar signs of VVA assessed by means of vulvoscopy	comparison between groups, mean change from Day 0 to Day 21	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	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	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	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	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	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	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	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	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	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	at Day 21

Collaborators and Investigators

• Sponsor: Nathura S.p.A
• Collaborators: Evidilya S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: CeleMD01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No