Vaginal atrophy in postmenopausal women MedDRA version: 14.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 100000004872
Conditions
Interventions
Product Name: Vagitocin (oxytocin gel)
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Concentration unit: IU international unit(s)
Concentration type: equal
Concent
Sponsors
PeP-Tonic Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who are postmenopausal women with vaginal atrophy as judged by the investigator - Subjects who are willing to participate in the study as indicated by signing the informed consent - Subjects who are healthy post-menopausal women between the ages of 40 and 70 years, inclusive - Subjects who have body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2 - Subjects who are judged by the Investigator to be healthy on the basis of medical evaluation 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Hospitalized subjects - Subject who have symptoms of any significant acute illnesses at the screening visit - Subjects who have a history of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product) - Subjects who have a known history of sensitivity to oxytocin or related derivatives - Subjects with FSH level < 40 pmol/mL - Subjects who have a known history of narcotic addiction, drug abuse or alcoholism - Subjects who simultaneously participate in another clinical study - Subjects who use any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline - Subjects who have uncontrolled hypertension and/or hypercholesterolemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 14 days and also to compare oxytocin bioavailability after vaginal and intravenous administration;Secondary Objective: Not applicable;Primary end point(s): - To determine the oxytocin plasma levels after intra-vaginal and intravenous administration and also pharmacokinetic parameters - To evaluate bioavailability of intravaginally administered oxytocin compared to intravenous administration ;Timepoint(s) of evaluation of this end point: Day 1, 5, 8, 12, 15, 16, 19, 22, 23, 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Recording of AE/SAE throughout the study ;Timepoint(s) of evaluation of this end point: Day 1, 15 and 22 | — |
Countries
Sweden
Contacts
Public ContactDan Markusson
PeP-Tonic Medical AB
Outcome results
None listed