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Gonadotropin

MENOPUR liquid for Infertility (CLARA Trial)

Phase 3
Waitlist Available
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of screening until the end-of-trial (up to approximately 6 months)
Awards & highlights

Summary

Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of screening until the end-of-trial (up to approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of screening until the end-of-trial (up to approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Fertilized (2 Pronuclei [2PN]) Oocytes
Secondary study objectives
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen
+50 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MENOPUR liquidExperimental Treatment2 Interventions
MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
Group II: MENOPUR powderActive Control2 Interventions
MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL
2019
Completed Phase 3
~410

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor
321 Previous Clinical Trials
1,242,735 Total Patients Enrolled
62 Trials studying Infertility
34,017 Patients Enrolled for Infertility
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
69 Previous Clinical Trials
1,159,052 Total Patients Enrolled
17 Trials studying Infertility
18,154 Patients Enrolled for Infertility
~68 spots leftby Oct 2025
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