Medicated Intrauterine Devices, Menorrhagia, Metrorrhagia
Conditions
Keywords
levonorgestrel, breakthrough bleeding
Brief summary
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
Detailed description
New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.
Interventions
DRUGTamoxifen
10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course
DRUGPlacebo (for Tamoxifen)
Sugar pill manufactured to mimic the tamoxifen 10mg tablet
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes * access to reliable cell phone * willing to receive and respond to daily text or email message to assess bleeding
Exclusion criteria
* using IUD for indication other than contraception * postpartum within 6 months, pregnant, or breastfeeding * removal and replacement of IUD * undiagnosed abnormal uterine bleeding prior to placement of IUD * bleeding dyscrasia * anti-coagulation use * active cervicitis * allergy to tamoxifen * history of venous thromboembolism * personal history of breast or uterine malignancy * use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Bleeding and Spotting Days | 30 days after initiation of study drug | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Pattern Satisfaction | 30 days after initiation of study drug | 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied. |
| IUD Satisfaction | 30 days after initiation of study drug | 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied. |
| Adverse Events | 30 days after initiation of study drug | Descriptive reporting of adverse events for each arm |
Other
| Measure | Time frame |
|---|---|
| Number of Prolonged Bleeding Episodes (>8 Days) | 60 days after initiation of study drug |
| Longest Bleed-free Interval | 60 days after initiation of study drug |
| Total Number of Bleeding/Spotting Episodes | 60 days after initiation of study drug |
Countries
United States
Participant flow
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not show up for allocation visit | 2 | 0 |
| Overall Study | Discontinued, IUS expulsion | 0 | 1 |
Baseline characteristics
| Characteristic | Tamoxifen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Continuous | 30.6 years STANDARD_DEVIATION 7.6 | 28.8 years STANDARD_DEVIATION 6.1 | 29.8 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized Other | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 17 Participants | 13 Participants | 30 Participants |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 12 / 17 | 15 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Number of Bleeding and Spotting Days
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamoxifen | Number of Bleeding and Spotting Days | 16.8 days | Standard Deviation 9 |
| Placebo | Number of Bleeding and Spotting Days | 12.0 days | Standard Deviation 5 |
Secondary
Adverse Events
Descriptive reporting of adverse events for each arm
Time frame: 30 days after initiation of study drug
Population: Adverse event information is reported in Adverse Event section of record summary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamoxifen | Adverse Events | 12 Events |
| Placebo | Adverse Events | 15 Events |
Secondary
Bleeding Pattern Satisfaction
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
Population: Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamoxifen | Bleeding Pattern Satisfaction | 50.7 units on a scale | Standard Deviation 28.6 |
| Placebo | Bleeding Pattern Satisfaction | 58.6 units on a scale | Standard Deviation 31.8 |
Secondary
IUD Satisfaction
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
Population: Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamoxifen | IUD Satisfaction | 82.7 units on a scale | Standard Deviation 22 |
| Placebo | IUD Satisfaction | 75.3 units on a scale | Standard Deviation 21.3 |
Other Pre-specified
Longest Bleed-free Interval
Time frame: 60 days after initiation of study drug
Population: Study ended up only collecting 30-day follow up data
Other Pre-specified
Number of Prolonged Bleeding Episodes (>8 Days)
Time frame: 60 days after initiation of study drug
Population: Study ended up only collecting 30-day follow up data
Other Pre-specified
Total Number of Bleeding/Spotting Episodes
Time frame: 60 days after initiation of study drug
Population: Study ended up only collecting 30-day follow up data