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

Pivotal Trial

Summary

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

Eligible Conditions

Infertility

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of screening until the end-of-trial (up to approximately 6 months)

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Do I qualify?Apply below to find out