NCT02310802

Brief Summary

The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2014

Geographic Reach
6 countries

18 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

November 19, 2014

Last Update Submit

October 20, 2017

Conditions

Infertility

Keywords

IVFICSI

Outcome Measures

Primary Outcomes (1)

  • EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat

    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.

    about 6 weeks post ET day

Secondary Outcomes (4)

  • EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test

    14 days post OPU day

  • EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat

    10 weeks post OPU day

  • EFFICACY ENDPOINTS The embryo-implantation rate

    6 weeks post ET day

  • EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions

    at 3.5 hours after dose administration

Other Outcomes (4)

  • SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity

    up to 10 weeks post OPU day

  • SAFETY ENDPOINTS (Haematology and biochemistry assessments)

    14 days post OPU day

  • PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001

    at 3.5 hours after dose administration

  • +1 more other outcomes

Study Arms (4)

OBE001 dose 1

EXPERIMENTAL
Drug: OBE001 dose 1

OBE001 dose 2

EXPERIMENTAL
Drug: OBE001 dose 2

OBE001 dose 3

EXPERIMENTAL
Drug: OBE001 dose 3

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OBE001 dose 1DRUG

OBE001 dispersible tablets for single oral administration

OBE001 dose 1
OBE001 dose 2DRUG

OBE001 dispersible tablets for single oral administration

OBE001 dose 2
OBE001 dose 3DRUG

OBE001 dispersible tablets for single oral administration

OBE001 dose 3
PlaceboDRUG

Placebo dispersible tablets for single oral administration

Placebo

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with medically indicated IVF or ICSI using her own oocytes.
  • GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
  • Evidence of uterine contractions by transvaginal ultrasound at baseline.

You may not qualify if:

  • Blastocyst stage or frozen-thaw transfers
  • Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
  • Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Hradev Kralove, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Zlín, Czechia

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Hvidovre, Denmark

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Alicante, Spain

Location

Unknown Facility

Barakaldo, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Bilbao, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Vigo, Spain

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33534895DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Clinical Study Director

    ObsEva SA

    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

November 19, 2014

First Posted

December 8, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2016

Last Updated

October 23, 2017

Record last verified: 2017-10

Locations

DK(2)PL(4)ES(6)GB(1)BE(1)CZ(4)