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

Phase 4

Completed

• Conditions: Bleeding; Implants; Breakthrough Bleeding
• Interventions: Drug: Placebo; Drug: Curcumin

• Registration Number: NCT04205929
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-20
• Study Start: 2020-04-15
• Primary Completion: 2022-11-05
• Results First Submitted: 2023-05-12
• Study Completion: 2023-08-01
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding
Curcumin group	Curcumin	Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding

Primary Outcome Measures

Name	Time	Method
Total Number of Days Without Bleeding or Spotting	Day 1 to Day 30	Total number of days without bleeding or spotting in the 30-day reference period

Secondary Outcome Measures

Name	Time	Method
Total Number of Bleeding Days	Day 1 to Day 30	Total number of days with bleeding in the 30-day reference period
Total Number of Bleeding/Spotting Days	Day 1 to Day 30	Total number of days with bleeding or spotting in the 30-day reference period
Total Number of Spotting Days	Day 1 to Day 30	Total number of days with spotting in the 30-day reference period

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States