Effect of Oxytocin Antagonist on Reduction of Uterine Contractions

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this clinical research trial was to evaluate the effects of barusiban compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte donors supplemented with progesterone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Oxytocin

Criteria

Participants eligible for this trial were oocyte donors 18-37 years of age, who had undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, had received hCG (10,000 IU urinary hCG or 250 μg recombinant hCG) for triggering of final follicular maturation and had undergone oocyte retrieval. Participants had given signed informed consent, were generally healthy and with a body mass index (BMI) of 18.5-29 kg/m2.

Participants were excluded in case of endometriosis stage I-IV or uterine pathology. Participants were willing to not have intake of alcoholic beverages during the trial, to not have sexual intercourse during the trial, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-trial till onset of next menses.