A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
American College of Obstetricians and Gynecologists