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NCT00328926 · ClinicalTrials.gov registry record · Phase 4
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
A Phase 4 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT00328926: Clinical Trial Phase 4 study, sponsored by EMD Serono.
NCT00328926 is a Phase 4 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00328926, a Phase 4 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
Primary Outcome
Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Interventions
- DRUG Placebo
- DRUG Recombinant human chorionic gonadotropin (r-hCG)
- DRUG Luveris® 75 IU
- DRUG Luveris® 25 IU
- DRUG Recombinant human follicle stimulating hormone (r-hFSH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
Why NCT00328926 stopped before completion
NCT00328926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00328926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00328926 about?
NCT00328926 is a clinical study titled "Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])". Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
What is the current status of trial NCT00328926?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2006-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00328926?
The interventions under investigation include: Placebo (DRUG), Recombinant human chorionic gonadotropin (r-hCG) (DRUG), Luveris® 75 IU (DRUG), Luveris® 25 IU (DRUG), Recombinant human follicle stimulating hormone (r-hFSH) (DRUG).
Who is sponsoring clinical trial NCT00328926?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00328926's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 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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