CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 173 enrolled
Drug / intervention
Menotropin +4 moredrug
Likely dose
Menotropin 225 IUfrom 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/NCT00802360
NCT00802360Phase 4Completed

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles

Ferring Pharmaceuticals·interventional·Posted Dec 4, 2008·Updated Nov 2, 2011

In Brief

A Phase 4 clinical trial evaluating Menotropin, Progestrone vaginal insert, and 3 other interventions for Infertility. Completed, enrolled 173 participants across 7 sites.

Detailed Summary

To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2008
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.6 years ago

Interventions

Menotropindrug

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Progestrone vaginal insertdrug

100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.

follitropin betadrug

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oildrug

50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.

Ganirelixdrug

Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.