A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-01
- Completion
- 2011-01
Outcome
Mixed primary results
registry MEDIAN Oral Naproxen: 27.5 (5 to 83) DAYS NCT00789802 ↗
registry MEDIAN Oral Placebo: 32 (9 to 84) DAYS NCT00789802 ↗
registry analysis (superiority or other test); Oral Naproxen vs Oral Placebo; p = .03; Wilcoxon (Mann-Whitney) NCT00789802 ↗
registry MEDIAN Transdermal Estradiol: 44 (2 to 82) DAYS NCT00789802 ↗
registry analysis (superiority or other test); Oral Placebo vs Transdermal Estradiol; p = .02; Wilcoxon (Mann-Whitney) NCT00789802 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.1 mg | Other |
| Subject | Naproxen | Small molecule | 500 mg | Oral |