Vaginal atrophy in postmenopausal women MedDRA version: 12.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy
Conditions
Interventions
Product Name: Vagitocin
Product Code: Not applicable
Pharmaceutical Form: Vaginal gel
Pharmaceutical form of the placebo: Vaginal gel
Route of administration of the placebo: Vaginal use
Sponsors
PeP-Tonic Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Signed informed consent -= 40 years of age -Naturally postmenopausal women, completely without menstrual bleedings for at least 4 years prior to screening. -FSH plasma levels = 40IU/L and 17-beta-estradiol levels 5.0 -BMI = 29 kg/m2 -Vaginal atrophy verified by cytological assessment of the vaginal mucosal epithelium. Vaginal atrophy is defined as = 5% superficial cells. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effect within 3 months prior to screening -Any condition that is a contraindication to treatment with sex steroids -Vaginal bleeding of unknown origin -Any untreated urogenital infection within 7 days prior to inclusion -Any prior or concurrent malignant disease or endometrial hyperplasia -Cervical cytology = CIN 1 assessed during screening -Systolic Blood Pressure = 140 mmHg or diastolic Blood Pressure = 90 mmHg at screening -Concurrent and diagnosed nephrologic or hepatic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if topical oxytocin can reverse vaginal atrophy, assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.;Secondary Objective: If topical oxytocin reverses vaginal atrophy, by cytological examination after 2 weeks of treatment as compared to placebo Effects of topical oxytocin on vaginal atrophy, by histological examination Effects of topical oxytocin on vaginal pH Effects of topical oxytocin on visual appearance of the vaginal mucosa Effects of topical oxytocin on subject quality of life Investigate systemic exposure of oxytocin after topical administration Effects of topical oxytocin on 17ß-estradiol plasma concentrations Investigate safety and tolerability of topical oxytocin treatment Investigate subject treatment compliance with topical oxytocin;Primary end point(s): -Cytological assessment (pap smear) of vaginal atrophy assessed as percentage of superficial, parabasal and intermediary cells and measured after 12 weeks of treatment with oxytocin/placebo. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed