NCT02309671

Brief Summary

This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 14, 2020

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 28, 2014

Last Update Submit

December 11, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes retrieved

    End of stimulation (max 16 days after investigational medicinal product (IMP) start)

Secondary Outcomes (8)

  • Number of follicles during stimulation

    Up to 16 days

  • Size of follicles during stimulation

    Up to 16 days

  • Endocrine profile measured by circulating levels of hormones

    Up to 16 days

  • Total IMP dose administered measured from first until last dose (end of stimulation)

    Up to 16 days

  • Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing

    5 days (from oocyte retrieval to embryo transfer)

  • +3 more secondary outcomes

Study Arms (4)

FE 999049 6 µg

EXPERIMENTAL
Drug: FE 999049

FE 999049 9 µg

EXPERIMENTAL
Drug: FE 999049

FE 999049 12 µg

EXPERIMENTAL
Drug: FE 999049

FOLLISTIM 150 IU

ACTIVE COMPARATOR

follitropin beta

Drug: follitropin beta

Interventions

FE 999049DRUG
FE 999049 12 µgFE 999049 6 µgFE 999049 9 µg
follitropin betaDRUG
Also known as: FOLLISTIM
FOLLISTIM 150 IU

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
  • Women eligible for IVF and/or ICSI treatment
  • Women aged 20-39 years
  • Women with body mass index (BMI) of 17.5-32.0 kg/m2

You may not qualify if:

  • Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
  • Women with history of recurrent miscarriage
  • Women with contraindications to controlled ovarian stimulation with gonadotropins
  • Women with three or more controlled ovarian stimulation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Location

Related Publications (1)

  • Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.

    PMID: 33272623RESULT

MeSH Terms

Conditions

Infertility

Interventions

FE 999049follitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

September 1, 2016

Last Updated

December 14, 2020

Record last verified: 2016-11

Locations

JP(1)