Back to resultsA Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
Primary Purpose
Vaginal Atrophy
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Vagitocin
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy
Eligibility Criteria
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
Sites / Locations
- Women's health clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vagitocin (Oxytocin)
Arm Description
Outcomes
Primary Outcome Measures
Oxytocin plasma levels
Oxytocin plasma levels after intravaginal and intravenous administration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01975129
Brief Title
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
Official Title
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women With Vaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PepTonic Medical AB
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vagitocin (Oxytocin)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vagitocin
Other Intervention Name(s)
Oxytocin gel 400 International Units
Primary Outcome Measure Information:
Title
Oxytocin plasma levels
Description
Oxytocin plasma levels after intravaginal and intravenous administration
Time Frame
Day 1 to 26
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aino Fianu Jonasson, MD Ass Prof
Organizational Affiliation
Karolinska University Hopsital, Womens Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's health clinic
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
We'll reach out to this number within 24 hrs