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Trial record 35 of 2076 for:    ESTRADIOL

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

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ClinicalTrials.gov Identifier: NCT00789802
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : December 11, 2014
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Tessa Madden, MD, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Contraception
Bleeding
Interventions Drug: transdermal estradiol
Drug: naproxen
Drug: oral placebo
Enrollment 129
Recruitment Details 129 participants were recruited from November 2008 to January 2010 and follow-up was conducted through May 2010.
Pre-assignment Details  
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol
Hide Arm/Group Description

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Period Title: Overall Study
Started 44 42 43
Completed 34 35 37
Not Completed 10 7 6
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol Total
Hide Arm/Group Description

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 44 42 43 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 43 participants 129 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
 100.0%
42
 100.0%
43
 100.0%
129
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 42 participants 43 participants 129 participants
26.3  (4.7) 25  (4.2) 26.2  (5.1) 25.8  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 42 participants 43 participants 129 participants
Female
44
 100.0%
42
 100.0%
43
 100.0%
129
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 42 participants 43 participants 129 participants
44 42 43 129
1.Primary Outcome
Title Number of Bleeding and Spotting Days
Hide Description The median number of bleeding and spotting days reported at 12 weeks.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol
Hide Arm/Group Description:

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Overall Number of Participants Analyzed 44 42 43
Median (Full Range)
Unit of Measure: DAYS
27.5
(5 to 83)
32
(9 to 84)
44
(2 to 82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Naproxen, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Placebo, Transdermal Estradiol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.
Hide Description Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Transdermal Estradiol Oral Naproxen Oral Placebo
Hide Arm/Group Description:

participants will be randomized to transdermal estradiol

transdermal estradiol: transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
Overall Number of Participants Analyzed 42 44 43
Median (Full Range)
Unit of Measure: days
35
(11 to 111)
53
(2 to 106)
38
(10 to 102)
3.Secondary Outcome
Title Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.
Hide Description To compare the level of patient satisfaction with the LNG-IUC at the end of the 12 weeks between the 3 study groups.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol
Hide Arm/Group Description:

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Overall Number of Participants Analyzed 36 39 37
Measure Type: Count of Participants
Unit of Measure: Participants
Satisfied
26
  72.2%
34
  87.2%
26
  70.3%
Somewhat satisfied
6
  16.7%
5
  12.8%
6
  16.2%
Not satisfied
4
  11.1%
0
   0.0%
5
  13.5%
4.Secondary Outcome
Title Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups
Hide Description To compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol
Hide Arm/Group Description:

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

Overall Number of Participants Analyzed 44 42 43
Measure Type: Count of Participants
Unit of Measure: Participants
34
  77.3%
35
  83.3%
37
  86.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Naproxen Oral Placebo Transdermal Estradiol
Hide Arm/Group Description

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 to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks

participants will be randomized to transdermal estradiol

transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks.

All-Cause Mortality
Oral Naproxen Oral Placebo Transdermal Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Naproxen Oral Placebo Transdermal Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/42 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Naproxen Oral Placebo Transdermal Estradiol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/42 (0.00%)   0/43 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tessa Madden
Organization: Washington University
Phone: 3147471331
EMail: maddent@wustl.edu
Layout table for additonal information
Responsible Party: Tessa Madden, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00789802     History of Changes
Other Study ID Numbers: 07-1026
First Submitted: November 11, 2008
First Posted: November 13, 2008
Results First Submitted: June 27, 2013
Results First Posted: December 11, 2014
Last Update Posted: March 20, 2018