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Completed

NCT Number: NCT04205929

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

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.

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Key information

Conditions

Bleeding Breakthrough Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Implants Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OHSU

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

curcumin

Drug

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

Primary outcomes

  1. Total Number of Days Without Bleeding or Spotting

    Time frame: Day 1 to Day 30

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

Secondary outcomes

  1. Total Number of Bleeding/Spotting Days

    Time frame: Day 1 to Day 30

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

  2. Total Number of Spotting Days

    Time frame: Day 1 to Day 30

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

  3. Total Number of Bleeding Days

    Time frame: Day 1 to Day 30

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

Other outcomes

  1. Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS

    Time frame: 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).

  2. Proportion of Participants Who Intend to Continue Use of Implant

    Time frame: Day 30

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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 20, 2019
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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