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

NCT04205929 | Completed Phase 4 Results DMC

• 1 other identifier: OHSU IRB 20645
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Implants; Breakthrough Bleeding

Keywords

Contraceptive implant; Irregular bleeding

Outcome Measures

Primary Outcomes (1)

• Total Number of Days Without Bleeding or Spotting

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

  Day 1 to Day 30

Secondary Outcomes (3)

• Total Number of Bleeding/Spotting Days

  Day 1 to Day 30

• Total Number of Spotting Days

  Day 1 to Day 30

• Total Number of Bleeding Days

  Day 1 to Day 30

Other Outcomes (2)

• Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS

  Day 1 to Day 30

• Proportion of Participants Who Intend to Continue Use of Implant

  Day 30

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding

Drug: Placebo

Curcumin group

EXPERIMENTAL

Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding

Drug: Curcumin

Interventions

Placebo DRUG

Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding

Placebo group

Curcumin DRUG

Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding

Curcumin group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Edelman A, Boniface E, Schrote K, Messerle-Forbes M, O'Donnell A, Jensen JT, Han L. Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin. Am J Obstet Gynecol. 2023 Aug;229(2):145.e1-145.e9. doi: 10.1016/j.ajog.2023.04.028. Epub 2023 Apr 26.

  PMID: 37116825 DERIVED

MeSH Terms

Conditions

Hemorrhage; Metrorrhagia

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Dr. Alison Edelman
• Organization: Oregon Health & Science University

edelmana@ohsu.edu

503-494-3666

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo-controlled Computer-generated randomization schema
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor OB/Gyn

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: April 15, 2020
• Primary Completion: November 5, 2022
• Study Completion: August 1, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)