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Curcumin for Breakthrough Bleeding
Phase 4
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 30
Awards & highlights
Study Summary
This trial will study the effects of curcumin on women who experience irregular bleeding while using the contraceptive implant.
Who is the study for?
This trial is for English-speaking women aged 15-45 who have been using a contraceptive implant for at least 30 days and are experiencing irregular bleeding. They must not be pregnant, breastfeeding, or have had certain cancers, and should not be on other conflicting medications.Check my eligibility
What is being tested?
The study is testing if curcumin (from turmeric) can help manage irregular bleeding in women using contraceptive implants compared to a placebo. Participants will report their bleeding patterns daily via text or email.See study design
What are the potential side effects?
While the trial's description doesn't list specific side effects of curcumin, common ones may include stomach upset, nausea, dizziness, or diarrhea. The placebo is unlikely to cause any side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of amenorrhea days
Secondary outcome measures
Number of consecutive bleeding-free days
Time (days) to stop bleeding
Total number of bleeding days
+2 moreOther outcome measures
Patient satisfaction with bleeding pattern as assessed by VAS
Proportion of participants who intend to continue use of implant
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Curcumin groupExperimental Treatment1 Intervention
Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Group II: Placebo groupPlacebo Group1 Intervention
Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
FDA approved
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
979 Previous Clinical Trials
7,386,403 Total Patients Enrolled
3 Trials studying Bleeding
167 Patients Enrolled for Bleeding
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,066,038 Total Patients Enrolled
1 Trials studying Bleeding
90 Patients Enrolled for Bleeding
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medications to prevent blood from clotting.You are allergic to curcumin or turmeric.You are taking a medication that affects the way other drugs are processed in your body.You have unexplained and ongoing heavy bleeding before getting the contraceptive implant.You have experienced heavy or frequent bleeding/spotting for more than a week in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: Curcumin group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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