NCT01043120

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

January 5, 2010

Last Update Submit

June 20, 2017

Conditions

In Vitro Fertilisation (IVF) Treatment

Outcome Measures

Primary Outcomes (2)

  • Frequency of uterine contractions, Intention-To-Treat (ITT) Analysis Set

    Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.

    30 minutes after start of dosing

  • Frequency of uterine contractions, Per-Protocol (PP) Analysis Set

    Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.

    30 minutes after start of dosing

Secondary Outcomes (5)

  • Uterine contractile measures

    During and after dosing (one day)

  • Inter-endometrial space

    30 minutes after start of dosing

  • Direction of Wave Propagation

  • Direction of Wave Propagation, Post-hoc analysis

    30 min after start of dosing and MET

  • Dispersion, Location, Distance from Point of Release and Velocity of Ultrasound Contrast Agent

Study Arms (2)

Barusiban

EXPERIMENTAL
Drug: Barusiban

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BarusibanDRUG

IV bolus of 20 mg for 1 minute followed by an IV infusion of 19 mg for up to 59 minutes. The maximum total duration of administration was 60 minutes.

Barusiban
PlaceboDRUG

IV bolus of saline (sodium chloride 0.9%) for 1 minute followed by an IV infusion of saline (sodium chloride 0.9%) for up to 59 minutes. Details on injection volume, infusion rates and doses are tabulated below.

Placebo

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

UZ Brussel

Brussels, Belgium

Location

IVF Institute

Pilsen, Czechia

Location

ISCARE IVF a.s.

Prague, Czechia

Location

IU Dexeus

Barcelona, Spain

Location

IVI Madrid

Madrid, Spain

Location

MeSH Terms

Interventions

barusiban

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

CZ(2)ES(2)BE(1)