Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
To insert the cream the patient must use the applicator provided in the way explained in the prospectus.
Instituto Palacios
Madrid, Spain
Vulvovaginal Symptoms
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit.
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of changes in ph.
Percentage of women with changes in pH at Visit 1 and Visit 2 compared to Screening Visit. Comparison with the two groups
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of vaginal maturation index by Pap smear.
Percentage of woman with changes in vaginal maturation index by Pap smear at Visit 2 compared to Screening Pap smear and comparison between groups.
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of changes in soreness and irritation.
Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit.
Time frame: Change from Baseline, at week 4 and at week 12
Occurrence of adverse events
Number of adverse events
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Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of endometrium thickness using vaginal ultrasound
Percentage of women with changes in endometrium thickness at Visit 2 compared to Screening Visit and comparison between groups
Time frame: Change from Baseline, at week 4 and at week 12