A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

Peptonic Medical

Status and phase

Completed

Phase 2

Conditions

Vaginal Atrophy

Treatments

Drug: Vagitocin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01975129

OXYPEP003

Details and patient eligibility

About

This study aims to evaluate the uptake of oxytocin following intravaginal administration of Vagitocin 400IU over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer Vagitocin intravaginally on day 2-14 (day 1 and 15 Vagitocin is given in the clinic). On day 22 a single intravenous dose of oxytocin 10 IU Syntocinon® will be given. Oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. Based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. The % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.

Enrollment

12 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Post-menopausal women with vaginal atrophy as judged by the investigator
Willing to participate in the study as indicated by signing the informed consent
Healthy post-menopausal women between the ages of 40 and 70 years, inclusive
Body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
Judged by the Investigator to be healthy on the basis of medical evaluation

Exclusion criteria

Hospitalized subjects
Symptoms of any significant acute illnesses at the screening visit
History of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
Known history of sensitivity to oxytocin or related derivatives
Follicle-stimulating hormone level < 40 pmol/mL
Known history of narcotic addiction, drug abuse or alcoholism
Simultaneously participate in another clinical study
Use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
Uncontrolled hypertension and/or hypercholesterolemia