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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
The investigators are proposing a randomized, double blind placebo-controlled clinical trial over a 30-day reference period for treatment of women experiencing bothersome bleeding while using the etonogestrel (ENG) contraceptive implant. The primary outcome of the study will be the total number of amenorrhea days in a 30-day reference period. The study has a number of secondary outcomes (see study objectives) focused around the efficacy of oral curcumin to stop bleeding/spotting and for how long.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding |
|
| Curcumin group | Experimental | Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Days Without Bleeding or Spotting | Total number of days without bleeding or spotting in the 30-day reference period | Day 1 to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Bleeding/Spotting Days | Total number of days with bleeding or spotting in the 30-day reference period | Day 1 to Day 30 |
| Total Number of Spotting Days | Total number of days with spotting in the 30-day reference period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS | Change in the level of patient satisfaction with bleeding pattern as measured by Visual Analog Scale (VAS) from Day 1 to Day 30. The scale ranges from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction). | Day 1 to Day 30 |
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 |
|---|---|---|---|
| 37116825 | Derived | Edelman A, Boniface E, Schrote K, Messerle-Forbes M, O'Donnell A, Jensen JT, Han L. Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin. Am J Obstet Gynecol. 2023 Aug;229(2):145.e1-145.e9. doi: 10.1016/j.ajog.2023.04.028. Epub 2023 Apr 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Placebo: Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
| FG001 | Curcumin Group | Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Curcumin: Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Placebo: Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
| BG001 | Curcumin Group |
| 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 Days Without Bleeding or Spotting | Total number of days without bleeding or spotting in the 30-day reference period | Posted | Mean | Standard Deviation | days | Day 1 to Day 30 |
|
Enrollment through 30 days of treatment
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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 | Placebo Group | Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Placebo: Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach cramps | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Edelman | Oregon Health & Science University | 503-494-3666 | edelmana@ohsu.edu |
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| 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 | Oct 15, 2019 | May 10, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2022 | May 10, 2023 | ICF_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 |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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Placebo-controlled Computer-generated randomization schema
| Curcumin | Drug | Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
|
| Day 1 to Day 30 |
| Total Number of Bleeding Days | Total number of days with bleeding in the 30-day reference period | Day 1 to Day 30 |
| Proportion of Participants Who Intend to Continue Use of Implant |
Percentage of participants who are continuing implant use or anticipate implant continuation, evaluated at the end of study |
| Day 30 |
Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Curcumin: Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Nulliparous | Count of Participants | Participants |
|
|
|
| Secondary | Total Number of Bleeding/Spotting Days | Total number of days with bleeding or spotting in the 30-day reference period | Posted | Mean | Standard Deviation | days | Day 1 to Day 30 |
|
|
|
| Secondary | Total Number of Spotting Days | Total number of days with spotting in the 30-day reference period | Posted | Mean | Standard Deviation | days | Day 1 to Day 30 |
|
|
|
| Secondary | Total Number of Bleeding Days | Total number of days with bleeding in the 30-day reference period | Posted | Mean | Standard Deviation | days | Day 1 to Day 30 |
|
|
|
| Other Pre-specified | Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS | Change in the level of patient satisfaction with bleeding pattern as measured by Visual Analog Scale (VAS) from Day 1 to Day 30. The scale ranges from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction). | Posted | Median | Inter-Quartile Range | units on a scale | Day 1 to Day 30 |
|
|
|
| Other Pre-specified | Proportion of Participants Who Intend to Continue Use of Implant | Percentage of participants who are continuing implant use or anticipate implant continuation, evaluated at the end of study | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Curcumin Group | Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Curcumin: Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding | 0 | 29 | 0 | 29 | 2 | 29 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Migraine headache | General 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |