At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled Trial of Oral Naproxen and Transdermal Estradiol for Prevention of Unscheduled Bleeding in New Users of Levonorgestrel Intrauterine Contraception
In Brief
A clinical study evaluating transdermal estradiol, naproxen, and 1 other intervention for Contraception and Bleeding. Completed, enrolled 129 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks