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

Bleeding Clinical Trial

Official title:

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04205929
• Other study ID #: OHSU IRB 20645
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 15, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: December 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 30, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Breakthrough Bleeding
• Hemorrhage
• Implants
• Metrorrhagia

Intervention

Drug:
• Placebo
Placebo (oral) once daily for 30 days. Treatment to be started after 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

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction with bleeding pattern as assessed by VAS	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).	Day 1 to Day 30
Other	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
Primary	Total number of amenorrhea days	Total number of bleeding free days in the 30-day reference period	Day 1 to Day 30
Secondary	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
Secondary	Number of consecutive bleeding-free days	Number of consecutive days with no bleeding after beginning treatment	Day 1 to Day 30
Secondary	Total number of spotting days	Total number of days with spotting in the 30-day reference period	Day 1 to Day 30
Secondary	Total number of bleeding days	Total number of days with bleeding in the 30-day reference period	Day 1 to Day 30
Secondary	Time (days) to stop bleeding	Number of days for bleeding to stop after beginning treatment	Day 1 to Day 30