OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
NCT ID: NCT02310802
Last Updated: 2017-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
247 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Detailed Description
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The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OBE001 dose 1
OBE001 dose 1
OBE001 dispersible tablets for single oral administration
OBE001 dose 2
OBE001 dose 2
OBE001 dispersible tablets for single oral administration
OBE001 dose 3
OBE001 dose 3
OBE001 dispersible tablets for single oral administration
Placebo
Placebo
Placebo dispersible tablets for single oral administration
Interventions
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OBE001 dose 1
OBE001 dispersible tablets for single oral administration
OBE001 dose 2
OBE001 dispersible tablets for single oral administration
OBE001 dose 3
OBE001 dispersible tablets for single oral administration
Placebo
Placebo dispersible tablets for single oral administration
Eligibility Criteria
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Inclusion Criteria
2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
3. Evidence of uterine contractions by transvaginal ultrasound at baseline.
Exclusion Criteria
2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome
18 Years
36 Years
FEMALE
No
Sponsors
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ObsEva SA
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Director
Role: STUDY_DIRECTOR
ObsEva SA
Locations
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Brussels, , Belgium
Hradev Kralove, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Zlín, , Czechia
Copenhagen, , Denmark
Hvidovre, , Denmark
Bialystok, , Poland
Katowice, , Poland
Szczecin, , Poland
Warsaw, , Poland
Alicante, , Spain
Barakaldo, , Spain
Barcelona, , Spain
Bilbao, , Spain
Seville, , Spain
Vigo, , Spain
London, , United Kingdom
Countries
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References
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Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.
Other Identifiers
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14-OBE001-013
Identifier Type: -
Identifier Source: org_study_id