Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
Summary
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active management of the third stage of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin.
Timeline
- Start
- 2016-11-23
- Primary completion
- 2019-03-01
- Completion
- 2019-03-04
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped: “Inability to reliably measure plasma oxytocin levels during third stage labour, regardless of administration method (intramuscular or inhaled).”
paper the primary endpoint being PK profiles of oxytocin IH and secondary endpoint of safety. PMID 37485589 ↗
paper PK profiles could not be established for oxytocin IH or IM in women in TSL PMID 37485589 ↗
Publications
- Oliver VL, Siederer S, Cahn A, Gajewska-Knapik K, Gibson RA, Goodall C, Kirkpatrick C, Murray J, Nguyen TH, Schneider I, Lambert P, McIntosh MP, Parry S. Exploring the role of ex vivo metabolism on blood and plasma measurements of oxytocin among women in the third stage of labour: A post hoc study. Br J Clin Pharmacol. 2023 Dec;89(12):3669-3680. doi: 10.1111/bcp.15865. Epub 2023 Aug 24.
- Gajewska-Knapik K, Kumar S, Sutton-Cole A, Palmer KR, Cahn A, Gibson RA, Kirkpatrick C, Parry S, Schneider I, Siederer S, Stylianou A, Hacquoil K, Powell M, Ellis M, McIntosh MP, Lambert P. Pharmacokinetics and safety of inhaled oxytocin compared with intramuscular oxytocin in women in the third stage of labour: A randomized open-label study. Br J Clin Pharmacol. 2023 Dec;89(12):3681-3689. doi: 10.1111/bcp.15860. Epub 2023 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 400 ug | Inhaled |
| Subject | Oxytocin | Peptide | 5 iu | Inhaled |
| Subject | Oxytocin | Peptide | 10 iu | Inhaled |
Indications
No indication recorded.