A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Drug: Vagitocin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, SE-141 86
      • Women's health clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vagitocin (Oxytocin)	Drug: Vagitocin; Other Names: Oxytocin gel 400 International Units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxytocin plasma levels	Oxytocin plasma levels after intravaginal and intravenous administration	Day 1 to 26

Collaborators and Investigators

• Sponsor: PepTonic Medical AB
• Investigators: Principal Investigator: Aino Fianu Jonasson, MD Ass Prof, Karolinska University Hopsital, Womens Health

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (ESTIMATE): November 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: OXYPEP003