A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

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.

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Key information

Conditions

Vaginal Atrophy

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women's health clinic

Stockholm, Huddinge, SE-141 86, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagitocin

Drug

Other names: Oxytocin gel 400 International Units

Primary outcomes

Oxytocin plasma levels

Time frame: Day 1 to 26

Oxytocin plasma levels after intravaginal and intravenous administration

Sponsors and collaborators

Lead sponsor

PepTonic Medical AB

Industry

Registry information

Official study title

A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Nov 4, 2013
Registry last updated: May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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