Trial Outcomes & Findings for A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC (NCT NCT00789802)
NCT ID: NCT00789802
Last Updated: 2018-03-20
Results Overview
The median number of bleeding and spotting days reported at 12 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-03-20
Participant Flow
129 participants were recruited from November 2008 to January 2010 and follow-up was conducted through May 2010.
Participant milestones
| Measure |
Oral Naproxen
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
oral placebo : 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
|
Transdermal Estradiol
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
43
|
|
Overall Study
COMPLETED
|
34
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Baseline characteristics by cohort
| Measure |
Oral Naproxen
n=44 Participants
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
n=42 Participants
oral placebo : 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
|
Transdermal Estradiol
n=43 Participants
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
129 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.7 • n=39 Participants
|
25 years
STANDARD_DEVIATION 4.2 • n=41 Participants
|
26.2 years
STANDARD_DEVIATION 5.1 • n=35 Participants
|
25.8 years
STANDARD_DEVIATION 4.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
129 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=39 Participants
|
42 participants
n=41 Participants
|
43 participants
n=35 Participants
|
129 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe median number of bleeding and spotting days reported at 12 weeks.
Outcome measures
| Measure |
Oral Naproxen
n=44 Participants
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
n=42 Participants
oral placebo : 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
|
Transdermal Estradiol
n=43 Participants
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
|---|---|---|---|
|
Number of Bleeding and Spotting Days
|
27.5 DAYS
Interval 5.0 to 83.0
|
32 DAYS
Interval 9.0 to 84.0
|
44 DAYS
Interval 2.0 to 82.0
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.
Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks.
Outcome measures
| Measure |
Oral Naproxen
n=42 Participants
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
n=44 Participants
oral placebo : 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
|
Transdermal Estradiol
n=43 Participants
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
|---|---|---|---|
|
Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.
|
35 days
Interval 11.0 to 111.0
|
53 days
Interval 2.0 to 106.0
|
38 days
Interval 10.0 to 102.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.
To compare the level of patient satisfaction with the LNG-IUC at the end of the 12 weeks between the 3 study groups.
Outcome measures
| Measure |
Oral Naproxen
n=36 Participants
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
n=39 Participants
oral placebo : 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
|
Transdermal Estradiol
n=37 Participants
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
|---|---|---|---|
|
Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.
Not satisfied
|
4 Participants
|
0 Participants
|
5 Participants
|
|
Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.
Satisfied
|
26 Participants
|
34 Participants
|
26 Participants
|
|
Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.
Somewhat satisfied
|
6 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksTo compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups
Outcome measures
| Measure |
Oral Naproxen
n=44 Participants
participants will be randomized to oral naproxen
naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks
|
Oral Placebo
n=42 Participants
oral placebo : 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
|
Transdermal Estradiol
n=43 Participants
participants will be randomized to transdermal estradiol
transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.
|
|---|---|---|---|
|
Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups
|
34 Participants
|
35 Participants
|
37 Participants
|
Adverse Events
Oral Naproxen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transdermal Estradiol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place