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NCT00789802 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 129
- Enrollment target
NCT00789802: Completed NA study, sponsored by Washington University School of Medicine.
NCT00789802 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 129 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00789802, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
Study Summary
We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.
Primary Outcome
The median number of bleeding and spotting days reported at 12 weeks.
Interventions
- DRUG oral placebo
- DRUG naproxen
- DRUG transdermal estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT00789802 record still lists
NCT00789802 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which oral placebo is the first listed.
NCT00789802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00789802 about?
NCT00789802 is a clinical study titled "A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC". We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this ...
What is the current status of trial NCT00789802?
This trial is currently completed. It is a NA study. The enrollment target is 129 participants. The study started on 2008-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00789802?
The interventions under investigation include: oral placebo (DRUG), naproxen (DRUG), transdermal estradiol (DRUG).
Who is sponsoring clinical trial NCT00789802?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00789802's enrollment target sits among peer trials
129 744th of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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