A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
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.