Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2019-09-24
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Celegyn®
Medical device Celegyn® presents itself as a cream.
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
Matching placebo
IP placebo presents itself as a cream.
Interventions
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Celegyn®
Medical device Celegyn® presents itself as a cream.
Matching placebo
IP placebo presents itself as a cream.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
65 Years
FEMALE
No
Sponsors
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Evidilya S.r.l.
INDUSTRY
Nathura S.p.A
INDUSTRY
Responsible Party
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Locations
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Spedali Civili di Brescia
Brescia, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CeleMD01
Identifier Type: -
Identifier Source: org_study_id
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