A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin

NCT01975129 | Completed Phase 2

• 1 other identifier: OXYPEP003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oxytocin plasma levels

  Oxytocin plasma levels after intravaginal and intravenous administration

  Day 1 to 26

Study Arms (1)

Vagitocin (Oxytocin)

EXPERIMENTAL

Drug: Vagitocin

Interventions

Vagitocin DRUG

Also known as: Oxytocin gel 400 International Units

Vagitocin (Oxytocin)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PepTonic Medical AB: lead

Study Sites (1)

Women's health clinic

Stockholm, Huddinge, SE-141 86, Sweden

Location

Study Officials

• Aino Fianu Jonasson, MD Ass Prof

  Karolinska University Hopsital, Womens Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

SE (1)