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A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

Sponsor
PepTonic Medical AB (Industry)
Overall Status
Completed
CT.gov ID
NCT01975129
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
5
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vagitocin (Oxytocin)

Drug: Vagitocin
Other Names:
  • Oxytocin gel 400 International Units

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oxytocin plasma levels [Day 1 to 26]

      Oxytocin plasma levels after intravaginal and intravenous administration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's health clinic Stockholm Huddinge Sweden SE-141 86

    Sponsors and Collaborators

    • PepTonic Medical AB

    Investigators

    • Principal Investigator: Aino Fianu Jonasson, MD Ass Prof, Karolinska University Hopsital, Womens Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PepTonic Medical AB
    ClinicalTrials.gov Identifier:
    NCT01975129
    Other Study ID Numbers:
    • OXYPEP003
    First Posted:
    Nov 3, 2013
    Last Update Posted:
    May 28, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Atrophy
    Oxytocin

    Study Results

    No Results Posted as of May 28, 2015