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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 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 129 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00789802
The ClinicalTrials.gov registry entry for NCT00789802 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which oral placebo is the first listed.
NCT00789802 reports 0 study locations.
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.
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