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

Study Overview
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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.

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.

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

Conditions
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Bleeding, Implants, Breakthrough Bleeding

Intervention / Treatment
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* Drug: Placebo
* Drug: Curcumin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraceptive implant, Irregular bleeding