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NCT00805935 · ClinicalTrials.gov registry record · Phase 4
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
A Phase 4 study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT00805935: Completed Phase 4 study, sponsored by Ferring Pharmaceuticals.
NCT00805935 is a Phase 4 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00805935, a Phase 4 study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study Summary
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
Primary Outcome
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Interventions
- DRUG leuprolide acetate
- DRUG Menotropin
- DRUG Progesterone vaginal insert
- DRUG Follitropin beta
- DRUG Progesterone in oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
What the finished NCT00805935 record still lists
NCT00805935 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 5 interventions - of which leuprolide acetate is the first listed.
NCT00805935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00805935 about?
NCT00805935 is a clinical study titled "Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)". This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the st...
What is the current status of trial NCT00805935?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2009-01. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00805935?
The interventions under investigation include: leuprolide acetate (DRUG), Menotropin (DRUG), Progesterone vaginal insert (DRUG), Follitropin beta (DRUG), Progesterone in oil (DRUG).
Who is sponsoring clinical trial NCT00805935?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00805935's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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