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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bleeding; Breakthrough Bleeding; Implants
• Intervention / Treatment: Drug: Placebo; Drug: Curcumin

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 Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Women's Health Research Unit Department of Ob/Gyn; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding	Drug: Placebo; Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
Experimental: Curcumin group; Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding	Drug: Curcumin; Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of amenorrhea days	Total number of bleeding free days in the 30-day reference period	Day 1 to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of consecutive bleeding-free days	Number of consecutive days with no bleeding after beginning treatment	Day 1 to Day 30
Total number of spotting days	Total number of days with spotting in the 30-day reference period	Day 1 to Day 30
Total number of bleeding days	Total number of days with bleeding in the 30-day reference period	Day 1 to Day 30
Time (days) to stop bleeding	Number of days for bleeding to stop after beginning treatment	Day 1 to Day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): November 5, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Contraceptive implant; Irregular bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Uterine Hemorrhage; Hemorrhage; Metrorrhagia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: OHSU IRB 20645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No