A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

NCT ID: NCT01975129

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-02-28

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.

Conditions

Vaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vagitocin (Oxytocin)

Group Type: EXPERIMENTAL

Vagitocin

Intervention Type: DRUG

Interventions

Vagitocin

Intervention Type: DRUG

Other Intervention Names

Oxytocin gel 400 International Units

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

PepTonic Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aino Fianu Jonasson, MD Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hopsital, Womens Health

Locations

Women's health clinic

Stockholm, Huddinge, Sweden

Countries

Sweden

Other Identifiers

OXYPEP003

Identifier Type: -

Identifier Source: org_study_id