Performance and Safety of Class IIb MD Celegyn® in VVA

Inclusion Criteria:

1. Female patients aged between 18 and 65 years.
2. Patients reporting vulvovaginal dryness associated with spontaneous pain and / ordyspareunia (minimum score of 30 on a 100 mm Visual Analogue Scale for both symptomsreferable to vulvovaginal atrophy: dryness and spontaneous pain and / or dyspareunia).
3. Patients sexually active (i.e. women who currently have intercourse or other sexualactivity (masturbation, etc) at least once a month (with or without a partner), or whohad intercourse or other sexual activity at least once a month in the past, but laterdecreased sexual activity due to excessive pain or vaginal dryness. Dyspareunia isdefined (2nd International Consultation on Sexual Medicine) as "persistent orrecurrent pain with attempted or complete vaginal entry and/or penile vaginalintercourse" that is not the result of other abnormalities).
4. Patients agreeing not to use lubricants or other topically applied vaginal productsduring the study and not to modify their personal hygiene products.
5. Patients of childbearing potential following a reliable (according to investigator'sopinion) 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) withinthe 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) orendometrial polyps, cancer, palpable fibroids or grade 2 uterine prolapse (when thecervix reaches the labia minora) on gynaecologic examination.
5. Patients presenting coagulation disorders or on anticoagulant drug therapy (exceptclopidogrel or acetylsalicylic acid).
6. Patients diagnosed with clinically significant metabolic or endocrine disease ordiabetes mellitus uncontrolled by medication.
7. Patients diagnosed with hypertension and in treatment with antihypertensivemedications.
8. Patients diagnosed with severe renal and/or hepatic insufficiency.
9. Patients who have changed or started systemic oestrogen - progestin or hormone therapyin the 3 months prior to inclusion (including contraceptive therapy (pill) orSubstitutive Hormonal Therapy (SHT)).
10. Patients on systemic chronic oestrogen - progestin therapy (including contraceptivetherapy (pill) or Substitutive Hormonal Therapy (SHT)).
11. Patients in treatment with the following systemic drug: nonsteroidal anti-inflammatorydrugs, antihistamines, corticosteroids in the 2 weeks prior to inclusion,immunosuppressants in the 3 months prior to inclusion, venotonic or diuretic agents inthe month prior to inclusion.
12. Patients using topic oestrogen - progestin or hormonal therapy, in the week prior toinclusion.
13. Patients in treatment with topically applied vaginal products, including medicationsto promote healing, in the week prior to inclusion.
14. Patients that participated in any other clinical trial during the last month orparticipating in any clinical trial while participating in this trial.
15. Patients reporting allergy or intolerance to any component of test product, placebo orrescue product.
16. Smoking patients.
17. Patients who in the opinion of the principal investigator are at risk ofnon-compliance to the study procedures or who are otherwise not appropriate to includein this clinical trial.
18. Patients presenting contraindications to the rescue product, according to concerningSummary of Product Characteristics (SPC).