Trial Outcomes & Findings for Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users (NCT NCT02903121)
NCT ID: NCT02903121
Last Updated: 2020-07-15
Results Overview
Bleeding free days in the first 30 days
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
109 participants
Primary outcome timeframe
Day 1 to Day 30
Results posted on
2020-07-15
Participant Flow
Participant milestones
| Measure |
Tamoxifen
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
52
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
23
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Baseline characteristics by cohort
| Measure |
Tamoxifen
n=55 Participants
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=52 Participants
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
23.4 Years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
23.9 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 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
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or unspecified
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Single or divorced
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Marital Status
Partnered or Married
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Education
High school or less
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
College (any or more)
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Days of implant use at study entry
|
370.8 Days
STANDARD_DEVIATION 267.7 • n=5 Participants
|
469.1 Days
STANDARD_DEVIATION 274.5 • n=7 Participants
|
418.6 Days
STANDARD_DEVIATION 274.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 30Bleeding free days in the first 30 days
Outcome measures
| Measure |
Tamoxifen
n=55 Participants
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=52 Participants
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
|
18.5 days
Standard Deviation 17
|
8.7 days
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Day 1 to Day 90bleeding free days in the first 90 days
Outcome measures
| Measure |
Tamoxifen
n=46 Participants
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=42 Participants
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.
|
60 days
Interval 18.0 to 84.0
|
52 days
Interval 11.0 to 67.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 of treatment number 4 to Day 90 (second 90 day reference period)bleeding free days in the second 90 days
Outcome measures
| Measure |
Tamoxifen
n=39 Participants
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=42 Participants
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90
|
56 days
Interval 6.0 to 81.0
|
67.5 days
Interval 7.0 to 83.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 of treatment 1 to day 180Patient satisfaction with bleeding pattern. Assessed by visual analog scale to determine satisfaction with bleeding patterns on a scale of 0-100 mm, where 0 mm represents not satisfied at all and 100 mm is totally satisfied.
Outcome measures
| Measure |
Tamoxifen
n=38 Participants
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=40 Participants
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Patient Satisfaction With Bleeding Pattern
|
67.5 mm
Interval 0.0 to 100.0
|
54.25 mm
Interval 0.5 to 98.0
|
Adverse Events
Tamoxifen
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tamoxifen
n=55 participants at risk
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Tamoxifen: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
Tamoxifen (open label): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
|
Placebo
n=52 participants at risk
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Placebo: Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
|
|---|---|---|
|
Reproductive system and breast disorders
Cramping, changes in menstrual fluid
|
5.5%
3/55 • 180 day duration of study participation
|
0.00%
0/52 • 180 day duration of study participation
|
|
Blood and lymphatic system disorders
Fluid retention
|
18.2%
10/55 • 180 day duration of study participation
|
1.9%
1/52 • 180 day duration of study participation
|
|
Nervous system disorders
Headache, migraine
|
29.1%
16/55 • 180 day duration of study participation
|
1.9%
1/52 • 180 day duration of study participation
|
|
Nervous system disorders
Hot flashes
|
10.9%
6/55 • 180 day duration of study participation
|
5.8%
3/52 • 180 day duration of study participation
|
|
Psychiatric disorders
Mood changes
|
20.0%
11/55 • 180 day duration of study participation
|
3.8%
2/52 • 180 day duration of study participation
|
|
Gastrointestinal disorders
Nausea, Vomiting
|
9.1%
5/55 • 180 day duration of study participation
|
3.8%
2/52 • 180 day duration of study participation
|
|
Nervous system disorders
Weakness, fatigue, dizziness
|
10.9%
6/55 • 180 day duration of study participation
|
1.9%
1/52 • 180 day duration of study participation
|
|
Reproductive system and breast disorders
Yeast infection, bacterial vaginosis
|
9.1%
5/55 • 180 day duration of study participation
|
0.00%
0/52 • 180 day duration of study participation
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/55 • 180 day duration of study participation
|
5.8%
3/52 • 180 day duration of study participation
|
Additional Information
Alison Edelman, MD, MPH
Oregon Health and Science University
Phone: 5034943666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place