Trial Outcomes & Findings for Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users (NCT NCT04205929)

NCT ID: NCT04205929

Last Updated: 2024-07-03

Results Overview

Total number of days without bleeding or spotting in the 30-day reference period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: Day 1 to Day 30
• Results posted on: 2024-07-03

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	29	29
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users

Baseline characteristics by cohort

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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	Total n=54 Participants Total of all reporting groups
Age, Continuous	24 years STANDARD_DEVIATION 3.7 • n=5 Participants	24 years STANDARD_DEVIATION 5.3 • n=7 Participants	24 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Hispanic/Latina	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · White	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Body mass index	24 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	25 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	24 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants
Nulliparous	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 30

Total number of days without bleeding or spotting in the 30-day reference period

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Total Number of Days Without Bleeding or Spotting	17.5 days Standard Deviation 4.8	16.7 days Standard Deviation 6.9

SECONDARY outcome

Timeframe: Day 1 to Day 30

Total number of days with bleeding or spotting in the 30-day reference period

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Total Number of Bleeding/Spotting Days	12.5 days Standard Deviation 4.8	13.3 days Standard Deviation 6.9

SECONDARY outcome

Timeframe: Day 1 to Day 30

Total number of days with spotting in the 30-day reference period

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Total Number of Spotting Days	4.9 days Standard Deviation 3.1	6.7 days Standard Deviation 4.3

SECONDARY outcome

Timeframe: Day 1 to Day 30

Total number of days with bleeding in the 30-day reference period

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Total Number of Bleeding Days	7.6 days Standard Deviation 4.5	6.6 days Standard Deviation 4.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 30

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).

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS	9.5 units on a scale Interval 0.8 to 53.0	42 units on a scale Interval 18.0 to 64.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 30

Percentage of participants who are continuing implant use or anticipate implant continuation, evaluated at the end of study

Outcome measures

Measure	Placebo Group n=28 Participants 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	Curcumin Group n=26 Participants 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
Proportion of Participants Who Intend to Continue Use of Implant	23 Participants	16 Participants

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Curcumin Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Group n=29 participants at risk 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	Curcumin Group n=29 participants at risk 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
Gastrointestinal disorders Stomach cramps	— 0/0 • Enrollment through 30 days of treatment	3.4% 1/29 • Number of events 1 • Enrollment through 30 days of treatment
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 1 • Enrollment through 30 days of treatment	0.00% 0/29 • Enrollment through 30 days of treatment
General disorders Migraine headache	0.00% 0/29 • Enrollment through 30 days of treatment	3.4% 1/29 • Number of events 1 • Enrollment through 30 days of treatment

Additional Information

Dr. Alison Edelman

Oregon Health & Science University

Phone: 503-494-3666

Email: edelmana@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place