A pharmacokinetic study of vaginally and intravenously administered oxytocin in postmenopausal women with vaginal atrophy

Conditions: Vaginal atrophy in postmenopausal women
MedDRA version: 14.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophySystem Organ Class: 100000004872
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-002690-22-SE

Lead Sponsor: PeP-Tonic Medical AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>- To evaluate bioavailability of intravaginally administered oxytocin compared to intravenous administration <br>;Timepoint(s) of evaluation of this end point: Day 1, 5, 8, 12, 15, 16, 19, 22, 23, 26

Secondary Outcome Measures