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Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women

NCT03296527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2023-08-24

Study results available
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Summary

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.

Conditions

  • Controlled Ovarian Simulation

Interventions

DRUG

Follitropin alfa

GONAL-F dose was fixed for the first 5 stimulation days.

DRUG

Follitropin delta

REKOVELLE (FE 999049) was fixed throughout the stimulation period.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-01-03
Completion
2020-07-26

Countries

  • China
  • South Korea
  • Taiwan
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296527 on ClinicalTrials.gov