An open-label study in healthy postpartum women investigating the transfer of the oxytocin receptor agonist FE 202767 from blood to breast milk after a single intravenous dose

• Research type

  Research Study

• Full title

  An open-label study in healthy postpartum women investigating the transfer of the oxytocin receptor agonist FE 202767 from blood to breast milk after a single intravenous dose.

• IRAS ID

  109004

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2012-001354-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  We are conducting a clinical trial sponsored by Ferring Pharmaceuticals A/S at our research centre with an investigational medicine called FE 202767 which is a drug which may help breast milk production after women have given birth. Voluteers taking part in the study must be multi-para females which means they must have given birth previously so that the childbirth associated with this study is not their first childbirth. Volunteers will be enrolled in the study if they are 18??40 years of age and have a normal pregnancy. Volunteers will attend our clinical unit for 1 screening visit before they give birth and 1 residential visit after they have given birth; when they will stay at our research unit over 3 days (2 nights) but will be involved in the study for 6 weeks in total while we assess their suitability for the study. In order to be included in the study, the enrolled volunteers must have given birth by vaginal delivery to a single child without complications, no more than 4 days before they are given FE 202767. Volunteers must have decided independently not to breast feed but must be able to express milk and their baby must be full-term, healthy and bottle-fed. During the study, volunteers will receive a single intravenous infusion of FE 202767 by gradual injection into the veins on 1 occasion after their breasts have been emptied of milk. The study procedures will include physical examination, medical history, blood and urine tests, alcohol breath test, ECGs, vital signs assessments and collection of breast milk and blood samples for analysis of FE 202767. The study is sponsored by Ferring Pharmaceuticals A/S., who are the manufacturers of FE 202767.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0274

• Date of REC Opinion

  4 Jul 2012

• REC opinion

  Further Information Favourable Opinion