Performance and Safety of Class IIb MD Celegyn® in VVA

NCT03823560 | Unknown

• 1 other identifier: CeleMD01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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)

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Assessment of Vaginal Health Index (VHI)

  comparison between groups, mean change from Day 0 to Day 21

  from Day 0 to Day 21

Secondary Outcomes (11)

• Assessment of vulvar signs of VVA assessed by means of vulvoscopy

  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)

  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

  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)

  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

  from Day 0 to 21

Study Arms (2)

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

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

Device: Matching placebo

Interventions

Celegyn® DEVICE

Medical device Celegyn® presents itself as a cream.

GROUP A: medical device Celegyn®

Matching placebo DEVICE

IP placebo presents itself as a cream.

GROUP B: matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Patients diagnosed with hypertension and in treatment with antihypertensive medications.
• Patients diagnosed with severe renal and/or hepatic insufficiency.
• Patients on systemic chronic oestrogen - progestin therapy (including contraceptive therapy (pill) or Substitutive Hormonal Therapy (SHT)).
• 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).

Sponsors & Collaborators

• Nathura S.p.A: lead
• Evidilya S.r.l.: collaborator

Study Sites (3)

Spedali Civili di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Central Study Contacts

Antonio Bertolino, PhD

CONTACT

+390249530065; antonio.bertolino@evidilya.com

Cesare Mutti

CONTACT

+390249530065; cesare.mutti@evidilya.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomised, double-blind, parallel groups, multicentric, placebo-controlled, prospective clinical study

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 30, 2019
• Study Start: September 24, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

IT (3)