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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2023-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bleeding Implants Breakthrough Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Placebo-controlled Computer-generated randomization schema

Study Groups

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Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Curcumin group

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

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type DRUG

Curcumin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes