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NCT00360490 · ClinicalTrials.gov registry record · Phase 3
Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
A Phase 3 study of Menorrhagia, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT00360490: Completed Phase 3 study of Menorrhagia, sponsored by Bayer.
NCT00360490 is a Phase 3 study of Menorrhagia that has completed, run by Bayer. The registered enrollment target is 165 participants, below the 212-participant average among 10 other Menorrhagia trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00360490, a Phase 3 study of Menorrhagia, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Primary Outcome
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
Conditions Studied
Interventions
- DRUG Medroxyprogesterone acetate
- DRUG Levonorgestrel IUS (Mirena, BAY86-5028)
Study Locations (20)
California
- - Beverly Hills
- - Carmichael
- - San Diego
- - San Diego
- - Santa Monica
- - Torrance
Florida
- - Boynton Beach
- - Jacksonville
- - West Palm Beach
Indiana
- - Newburgh
- - South Bend
Louisiana
- - Amite
- - Marrero
Arizona
- - Tucson
Colorado
- - Littleton
Idaho
- - Boise
Illinois
- - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00360490 record still lists
NCT00360490 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 212-participant average among 10 other Menorrhagia trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Menorrhagia appearing as the primary indexed condition, and to 2 interventions - of which Medroxyprogesterone acetate is the first listed.
NCT00360490 names 20 study sites across 11 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00360490 about?
NCT00360490 is a clinical study titled "Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)". The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
What is the current status of trial NCT00360490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2006-07. Estimated completion is 2008-06.
What conditions does trial NCT00360490 study?
This clinical trial studies the following conditions: Menorrhagia.
What interventions are being tested in trial NCT00360490?
The interventions under investigation include: Medroxyprogesterone acetate (DRUG), Levonorgestrel IUS (Mirena, BAY86-5028) (DRUG).
Who is sponsoring clinical trial NCT00360490?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00360490 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00360490's enrollment target sits among peer trials
165 6th of 10 higher than 5 of 10 other Menorrhagia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menorrhagia 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.
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