A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975129
• Other study ID #: OXYPEP003
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2013
• Last updated: May 27, 2015
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: PeP-Tonic Medical AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• Vagitocin

Locations

Country	Name	City	State
Sweden	Women's health clinic	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
PeP-Tonic Medical AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxytocin plasma levels	Oxytocin plasma levels after intravaginal and intravenous administration	Day 1 to 26	No