A randomized, double-blind, placebo controlled Phase 2b study, divided in 2 parts: * The main part of the study investigates the efficacy and safety of the Investigational Medicinal Product (IMP), intravaginally administered in glass syringes, on postmenopausal women with vulvovaginal atrophy symptoms. * The exploratory part of the study investigates the efficacy and safety of the IMP, intravaginally administered in a laminate tube, on postmenopausal women with vulvovaginal atrophy symptoms. A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients. In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes. In the exploratory part of the study, 40 patients will be enrolled and randomized to 2 different groups; 30 subjects receiving IMP and 10 patients receiving placebo, in laminate tubes. The study is conducted at 3 sites in Sweden, and comprises 5 visits: screening visit (Visit 0), randomization visit (Visit 1; Day 0), treatment follow-up visit (Visit 2; Week 4), end of treatment visit (Visit 3; Week 12) and a telephone follow-up visit (Visit 4; Week 14). All patients self-administer the IMP once daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Matching placebo gel with identical appearance to the test product, used as reference treatment.
Kvinnoforskningsenheten K59, Karolinska Universitetssjukhuset
Huddinge, Sweden
Kvinnokliniken, Norrlands Universitetssjukhus
Umeå, Sweden
Kvinnokliniken, Akademiska sjukhuset
Uppsala, Sweden
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity \[yes/no\]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Time frame: Baseline and after 12 weeks of treatment.
Change in vaginal pH
Change in vaginal pH (decrease is positive).
Time frame: Baseline and 12 weeks of treatment.
Change in % superficial cells
Change in % superficial cells in vaginal smear (increase is positive).
Time frame: Baseline and 12 weeks of treatment.
Change in maturation value
Change in maturation value (MV) (increase is positive). Maturation value is calculated using the percentage of parabasal cells, intermediate cells, and superficial cells in vaginal smear.
Time frame: Baseline and 12 weeks of treatment.
Change in summary score for the vulvovaginal atrophy symptoms.
Change in summary score for the VVA symptoms vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness and dysuria (decrease is positive).
Time frame: Baseline and 12 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity \[yes/no\]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Time frame: Baseline and 4 weeks of treatment.
Change in % superficial cells
Change in % superficial cells in vaginal smear (increase is positive).
Time frame: Baseline and 4 weeks of treatment.
Change in vaginal pH
Change in vaginal pH (decrease is positive).
Time frame: Baseline and 4 weeks of treatment.
Change in % parabasal cells
Change in % parabasal cells (decrease is positive).
Time frame: Baseline and 4 and 12 weeks of treatment.
Change in maturation value
Change in maturation value (MV) (increase is positive). Maturation value is calculated using the percentage of parabasal cells, intermediate cells, and superficial cells in vaginal smear.
Time frame: Baseline and 4 weeks of treatment.
Change in severity of the most bothersome VVA symptom.
Change in severity of the VVA symptom (vulvar/vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or the absence or presence of vaginal bleeding associated with vaginal sexual activity \[yes/no\]) that has been self-identified by the subject as being the most bothersome to her at baseline.
Time frame: Baseline and 4 and 12 weeks of treatment.
Change in Quality of Life evaluation parameters.
Change in Quality of Life evaluation parameters.
Time frame: Baseline and 12 weeks of treatment
Change in body weight.
Change in body weight.
Time frame: Baseline and 12 weeks of treatment
Change over time of clinical safety data.
Change over time of clinical safety data (adverse events, vital signs, physical, gynecological and breast examination findings, laboratory tests, transvaginal ultrasound and pap smear).
Time frame: Baseline and up to 14 weeks after first dose.
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