Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT04245293
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant and in menopausal transition period (late peri-menopause) women following the STRAW criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years.
* Diagnosis of vaginal dryness by subjective dryness, any objective sign of VVA, pH\>5 as reported in the AGATA study and VHI \< 15.
* Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
* Females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
* Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
* Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion Criteria:
* Women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit).
* Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
* Genital bleeding.
* Estrogen vaginal treatment during the study period (permitted only if terminated at least 6 months before study).
* Systemic estrogen therapy (permitted only if terminated at least 6 months before study).
* Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
* Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
* Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
* Known allergy to tested IMDs or its excipients.
* Drug or alcohol abuse within 12 months of Day 0.
* Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
* Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
55 Years
Study:
NCT04245293
Study Brief:
Protocol Section:
NCT04245293