Trial Outcomes & Findings for Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) (NCT NCT02824224)
NCT ID: NCT02824224
Last Updated: 2019-06-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
30 days after initiation of study drug
Results posted on
2019-06-04
Participant Flow
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)
Participant milestones
| Measure |
Tamoxifen
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
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 Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tamoxifen
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
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 Study
Discontinued, IUS expulsion
|
0
|
1
|
|
Overall Study
Did not show up for allocation visit
|
2
|
0
|
Baseline Characteristics
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Baseline characteristics by cohort
| Measure |
Tamoxifen
n=17 Participants
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
n=17 Participants
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
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.6 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after initiation of study drugMean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group
Outcome measures
| Measure |
Tamoxifen
n=17 Participants
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
n=17 Participants
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
|
|---|---|---|
|
Number of Bleeding and Spotting Days
|
16.8 days
Standard Deviation 9.0
|
12.0 days
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 30 days after initiation of study drugPopulation: Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.
Outcome measures
| Measure |
Tamoxifen
n=15 Participants
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
n=15 Participants
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
|
|---|---|---|
|
Bleeding Pattern Satisfaction
|
50.7 units on a scale
Standard Deviation 28.6
|
58.6 units on a scale
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: 30 days after initiation of study drugPopulation: Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.
Outcome measures
| Measure |
Tamoxifen
n=15 Participants
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
n=15 Participants
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
|
|---|---|---|
|
IUD Satisfaction
|
82.7 units on a scale
Standard Deviation 22.0
|
75.3 units on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 30 days after initiation of study drugPopulation: Adverse event information is reported in "Adverse Event" section of record summary.
Descriptive reporting of adverse events for each arm
Outcome measures
| Measure |
Tamoxifen
n=17 Participants
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
n=17 Participants
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
|
|---|---|---|
|
Adverse Events
|
12 Events
|
15 Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days after initiation of study drugPopulation: Study ended up only collecting 30-day follow up data
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days after initiation of study drugPopulation: Study ended up only collecting 30-day follow up data
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 days after initiation of study drugPopulation: Study ended up only collecting 30-day follow up data
Outcome measures
Outcome data not reported
Adverse Events
Tamoxifen
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tamoxifen
n=17 participants at risk
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
n=17 participants at risk
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
|
|---|---|---|
|
General disorders
Hot flashes
|
5.9%
1/17 • 30 days after initiating study medication.
|
5.9%
1/17 • 30 days after initiating study medication.
|
|
General disorders
Mood changes
|
11.8%
2/17 • 30 days after initiating study medication.
|
29.4%
5/17 • 30 days after initiating study medication.
|
|
General disorders
Headache
|
35.3%
6/17 • 30 days after initiating study medication.
|
29.4%
5/17 • 30 days after initiating study medication.
|
|
General disorders
Nausea
|
5.9%
1/17 • 30 days after initiating study medication.
|
17.6%
3/17 • 30 days after initiating study medication.
|
|
General disorders
Weight loss
|
5.9%
1/17 • 30 days after initiating study medication.
|
0.00%
0/17 • 30 days after initiating study medication.
|
|
General disorders
Fluid retention
|
5.9%
1/17 • 30 days after initiating study medication.
|
11.8%
2/17 • 30 days after initiating study medication.
|
Additional Information
Ob/Gyn Regulatory Specialist
Oregon Health & Science University
Phone: 5034940757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place