Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 10mg tablet by mouth twice daily for 7 days |
|
| Placebo | Placebo Comparator | Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after initiation of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after initiation of study drug |
| IUD Satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Bleeding/Spotting Episodes | 60 days after initiation of study drug | |
| Number of Prolonged Bleeding Episodes (>8 Days) | 60 days after initiation of study drug | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Megan A Cohen, MD, MPH | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Center For Women's Health | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31226322 | Derived | Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial. Contraception. 2019 Nov;100(5):391-396. doi: 10.1016/j.contraception.2019.06.009. Epub 2019 Jun 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for Tamoxifen) | Drug | Sugar pill manufactured to mimic the tamoxifen 10mg tablet |
|
0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.
| 30 days after initiation of study drug |
| Adverse Events | Descriptive reporting of adverse events for each arm | 30 days after initiation of study drug |
| Longest Bleed-free Interval |
| 60 days after initiation of study drug |
Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days
Placebo (for Tamoxifen): Sugar pill manufactured to mimic the tamoxifen 10mg tablet
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | days | 30 days after initiation of study drug |
|
|
| |||||||||||||||||||||||||||||
| 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. | Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen). | Posted | Mean | Standard Deviation | units on a scale | 30 days after initiation of study drug |
|
| |||||||||||||||||||||||||||||
| 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. | Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen). | Posted | Mean | Standard Deviation | units on a scale | 30 days after initiation of study drug |
|
| |||||||||||||||||||||||||||||
| Secondary | Adverse Events | Descriptive reporting of adverse events for each arm | Adverse event information is reported in "Adverse Event" section of record summary. | Posted | Number | Events | 30 days after initiation of study drug |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Total Number of Bleeding/Spotting Episodes | Study ended up only collecting 30-day follow up data | Posted | 60 days after initiation of study drug |
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Prolonged Bleeding Episodes (>8 Days) | Study ended up only collecting 30-day follow up data | Posted | 60 days after initiation of study drug |
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Longest Bleed-free Interval | Study ended up only collecting 30-day follow up data | Posted | 60 days after initiation of study drug |
|
|
30 days after initiating study medication.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 17 | 0 | 17 | 12 | 17 |
| EG001 | 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 | 0 | 17 | 0 | 17 | 15 | 17 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flashes | General disorders | Systematic Assessment |
| ||
| Mood changes | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Weight loss | General disorders | Systematic Assessment |
| ||
| Fluid retention | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ob/Gyn Regulatory Specialist | Oregon Health & Science University | 5034940757 | mccrimmo@ohsu.edu |
| Apr 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
Not provided
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Other |
|
|
|
|