Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
Primary Purpose
Bleeding, Implants, Breakthrough Bleeding
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Curcumin
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding focused on measuring Contraceptive implant, Irregular bleeding
Eligibility Criteria
Inclusion Criteria:
- English speaking
- Women 15-45 years of age
- Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
- Willing to continue using the implant for at least 30 days from study enrollment
- >7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
- Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
- Negative gonorrhea/chlamydia screening performed at screening visit
Exclusion Criteria:
- Postpartum within six months
- Post-abortion within six weeks
- Currently pregnant
- Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
- Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
- Bleeding dyscrasia
- Anticoagulation use
- Active cervicitis
- Allergy to curcumin or turmeric
- History of venous thromboembolism
- Current or past breast or uterine malignancy
- Use of P450 pathway inducing drug
- Implant is due to be switched out in 2 months or less from enrollment
- Currently using oral contraceptives in addition to implant (to be eligible, needs to have a 4-6 week washout period)
- Prior pregnancy occurred while Nexplanon/Implanon was in place
Sites / Locations
- OHSU
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Curcumin group
Arm Description
Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Outcomes
Primary Outcome Measures
Total number of amenorrhea days
Total number of bleeding free days in the 30-day reference period
Secondary Outcome Measures
Total number of bleeding/spotting days
Total number of days with bleeding or spotting in the 30-day reference period
Number of consecutive bleeding-free days
Number of consecutive days with no bleeding after beginning treatment
Total number of spotting days
Total number of days with spotting in the 30-day reference period
Total number of bleeding days
Total number of days with bleeding in the 30-day reference period
Time (days) to stop bleeding
Number of days for bleeding to stop after beginning treatment
Full Information
NCT ID
NCT04205929
First Posted
December 16, 2019
Last Updated
December 20, 2022
Sponsor
Oregon Health and Science University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04205929
Brief Title
Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
Official Title
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Implants, Breakthrough Bleeding
Keywords
Contraceptive implant, Irregular bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Placebo-controlled Computer-generated randomization schema
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Arm Title
Curcumin group
Arm Type
Experimental
Arm Description
Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
Primary Outcome Measure Information:
Title
Total number of amenorrhea days
Description
Total number of bleeding free days in the 30-day reference period
Time Frame
Day 1 to Day 30
Secondary Outcome Measure Information:
Title
Total number of bleeding/spotting days
Description
Total number of days with bleeding or spotting in the 30-day reference period
Time Frame
Day 1 to Day 30
Title
Number of consecutive bleeding-free days
Description
Number of consecutive days with no bleeding after beginning treatment
Time Frame
Day 1 to Day 30
Title
Total number of spotting days
Description
Total number of days with spotting in the 30-day reference period
Time Frame
Day 1 to Day 30
Title
Total number of bleeding days
Description
Total number of days with bleeding in the 30-day reference period
Time Frame
Day 1 to Day 30
Title
Time (days) to stop bleeding
Description
Number of days for bleeding to stop after beginning treatment
Time Frame
Day 1 to Day 30
Other Pre-specified Outcome Measures:
Title
Patient satisfaction with bleeding pattern as assessed by VAS
Description
Level of patient satisfaction with bleeding pattern as measured by Visual Analog Scale (VAS). The scale ranges from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction).
Time Frame
Day 1 to Day 30
Title
Proportion of participants who intend to continue use of implant
Description
Percentage of participants who are continuing implant use or anticipate implant continuation, evaluated at the end of study
Time Frame
Day 30
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking
Women 15-45 years of age
Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
Willing to continue using the implant for at least 30 days from study enrollment
>7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
Negative gonorrhea/chlamydia screening performed at screening visit
Exclusion Criteria:
Postpartum within six months
Post-abortion within six weeks
Currently pregnant
Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
Bleeding dyscrasia
Anticoagulation use
Active cervicitis
Allergy to curcumin or turmeric
History of venous thromboembolism
Current or past breast or uterine malignancy
Use of P450 pathway inducing drug
Implant is due to be switched out in 2 months or less from enrollment
Currently using oral contraceptives in addition to implant (to be eligible, needs to have a 4-6 week washout period)
Prior pregnancy occurred while Nexplanon/Implanon was in place
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
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