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Trial record 90 of 404 for:    LEVONORGESTREL

Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

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ClinicalTrials.gov Identifier: NCT02824224
Recruitment Status : Completed
First Posted : July 6, 2016
Results First Posted : May 21, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Menorrhagia
Metrorrhagia
Medicated Intrauterine Devices
Interventions Drug: Tamoxifen
Drug: Placebo (for Tamoxifen)
Enrollment 42
Recruitment Details  
Pre-assignment Details Excluded (n=5) from participation after signing informed consent form. Discontinued IUD (n=1) Declined to participate (n=2) Non-compliant with diaries (n=2)
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Period Title: Overall Study
Started 19 18
Completed 17 17
Not Completed 2 1
Reason Not Completed
Discontinued, IUS expulsion             0             1
Did not show up for allocation visit             2             0
Arm/Group Title Tamoxifen Placebo Total
Hide Arm/Group Description

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
1
   5.9%
0
   0.0%
1
   2.9%
Between 18 and 65 years
16
  94.1%
17
 100.0%
33
  97.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
30.6  (7.6) 28.8  (6.1) 29.8  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
17
 100.0%
17
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
White, non-Hispanic
17
 100.0%
13
  76.5%
30
  88.2%
Other
0
   0.0%
4
  23.5%
4
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title Number of Bleeding and Spotting Days
Hide Description Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group
Time Frame 30 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: days
16.8  (9.0) 12.0  (5.0)
2.Secondary Outcome
Title Bleeding Pattern Satisfaction
Hide Description 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.
Time Frame 30 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.7  (28.6) 58.6  (31.8)
3.Secondary Outcome
Title IUD Satisfaction
Hide Description 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.
Time Frame 30 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.7  (22.0) 75.3  (21.3)
4.Secondary Outcome
Title Adverse Events
Hide Description Descriptive reporting of adverse events for each arm
Time Frame 30 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event information is reported in "Adverse Event" section of record summary.
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: Events
12 15
5.Other Pre-specified Outcome
Title Total Number of Bleeding/Spotting Episodes
Hide Description [Not Specified]
Time Frame 60 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Study ended up only collecting 30-day follow up data
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Number of Prolonged Bleeding Episodes (>8 Days)
Hide Description [Not Specified]
Time Frame 60 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Study ended up only collecting 30-day follow up data
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Longest Bleed-free Interval
Hide Description [Not Specified]
Time Frame 60 days after initiation of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Study ended up only collecting 30-day follow up data
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description:

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 30 days after initiating study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tamoxifen Placebo
Hide Arm/Group Description

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Tamoxifen: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet

All-Cause Mortality
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamoxifen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/17 (70.59%)   15/17 (88.24%) 
General disorders     
Hot flashes   1/17 (5.88%)  1/17 (5.88%) 
Mood changes   2/17 (11.76%)  5/17 (29.41%) 
Headache   6/17 (35.29%)  5/17 (29.41%) 
Nausea   1/17 (5.88%)  3/17 (17.65%) 
Weight loss   1/17 (5.88%)  0/17 (0.00%) 
Fluid retention   1/17 (5.88%)  2/17 (11.76%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ob/Gyn Regulatory Specialist
Organization: Oregon Health & Science University
Phone: 5034940757
EMail: mccrimmo@ohsu.edu
Layout table for additonal information
Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02824224     History of Changes
Other Study ID Numbers: STUDY00015881
First Submitted: July 2, 2016
First Posted: July 6, 2016
Results First Submitted: April 8, 2019
Results First Posted: May 21, 2019
Last Update Posted: June 4, 2019