| December 21, 2007 |
| April 16, 2009 |
| November 2007 |
| September 2008 (final data collection date for primary outcome measure) |
| Frequency of uterine contractions at 3 hours after start of dosing. [ Time Frame: 3h after start of dosing ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00587327 on ClinicalTrials.gov Archive Site |
| Period, external, internal, and total contractile measure of uterine contractions.
Frequency, period, external, internal, and total contractile measure [ Time Frame: 3h after start of dosing ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions |
| A Randomised, Double-Blind, Parallel Groups, Placebo-Controlled, Multi-Centre Study Assessing the Effects of a Selective Oxytocin Antagonist (Barusiban) and a Mixed Oxytocin Antagonist - Vasopressin V1a Antagonist (Atosiban) Administered Intravenously on Luteal Phase Uterine Contractions in Oocyte Donors Supplemented With Vaginal Progesterone |
The main purpose of this clinical research study is to investigate if barusiban and/or atosiban can reduce the frequency of contractions in the womb at a time when fertilised eggs would be placed in the womb in patients undergoing IVF |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| In Vitro Fertilisation (IVF) Treatment. |
- Drug: Barusiban
- Drug: Atosiban
- Drug: Placebo
|
| |
| |
| |
| Completed |
| 125 |
| September 2008 |
| September 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Oocyte donors 18-35 years of age, who have undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, have received hCG (≥ 5,000 IU urinary hCG or 250 μg recombinant hCG) for triggering final follicular maturation and have underwent oocyte retrieval with a yield of ≥ 6 cumulus-oocyte-complexes.
- Generally healthy subjects and with a BMI of 18.5-29.9 kg/m2.
Exclusion Criteria:
- Subjects are excluded in case of endometriosis stage I-IV or uterine pathology. Subjects must be willing to not have intake of alcoholic beverages during the study, to not have sexual intercourse during the study, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-study till onset of next menses.
|
| Female |
| 18 Years to 35 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Czech Republic, Spain |
| |
| NCT00587327 |
| Hjort, Director, Ferring Pharmaceuticals |
| FE200440 CS09 |
| Ferring Pharmaceuticals |
|
| Study Director: |
Clinical Development Support |
Ferring Pharmaceuticals |
|
|
| Ferring Pharmaceuticals |
| April 2009 |
