CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL +3 moredrug
Likely dose
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04163458
NCT04163458Phase 3Completed

A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program

Ferring Pharmaceuticals·interventional·Posted Nov 14, 2019·Updated Nov 7, 2023

In Brief

A Phase 3 clinical trial evaluating MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL, MENOPUR powder and solvent for solution for injection, 75 IU, and 2 other interventions for Infertility. Completed, enrolled 405 participants across 20 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 14, 2019
Enrollment StartOct 25, 2019
Primary CompletionMay 28, 2021
Study CompletionJul 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.6 years ago

Interventions

MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mLdrug

Solution for injection in pre-filled pen, subcutaneous administration

MENOPUR powder and solvent for solution for injection, 75 IUdrug

Solution for injection in vials (powder and diluent), subcutaneous administration

Placebo (for MENOPUR solution for injection in pre-filled pen)other

Solution for injection in pre-filled pen, subcutaneous administration

Placebo (for MENOPUR powder and solvent for solution for injection)other

Solution for injection in vials (powder and diluent); subcutaneous administration