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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
The investigators will perform a 2 phase trial for treatment of women experiencing frequent or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day reference period and the second phase will allow both study arms to receive open-label treatment over an additional 90-day reference period. The primary outcome of the study will be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding |
|
| Placebo | Placebo Comparator | Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) | Bleeding free days in the first 30 days | Day 1 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1. | bleeding free days in the first 90 days | Day 1 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90 | bleeding free days in the second 90 days | Day 1 of treatment number 4 to Day 90 (second 90 day reference period) |
| Patient Satisfaction With Bleeding Pattern |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32649493 | Derived | Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) | Bleeding free days in the first 30 days | Posted | Mean | Standard Deviation | days | Day 1 to Day 30 |
|
180 day duration of study participation
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| 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 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramping, changes in menstrual fluid | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | 5034943666 | edelmana@ohsu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2019 | Jun 17, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
| Placebo | Drug | 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 |
|
| Tamoxifen (open label) | Drug | 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 |
|
|
Patient 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. |
| Day 1 of treatment 1 to day 180 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Days of implant use at study entry | Mean | Standard Deviation | Days |
|
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 |
|
|
| Secondary | Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1. | bleeding free days in the first 90 days | Posted | Median | Full Range | days | Day 1 to Day 90 |
|
|
|
| Other Pre-specified | Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90 | bleeding free days in the second 90 days | Posted | Median | Full Range | days | Day 1 of treatment number 4 to Day 90 (second 90 day reference period) |
|
|
|
| Other Pre-specified | Patient Satisfaction With Bleeding Pattern | Patient 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. | Posted | Median | Full Range | mm | Day 1 of treatment 1 to day 180 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 45 |
| 55 |
| EG001 | 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 | 0 | 52 | 0 | 52 | 12 | 52 |
| Fluid retention | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Headache, migraine | Nervous system disorders | Non-systematic Assessment |
|
| Hot flashes | Nervous system disorders | Non-systematic Assessment |
|
| Mood changes | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea, Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weakness, fatigue, dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Yeast infection, bacterial vaginosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |