Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oregon Health and Science University
With
Merck Sharp & Dohme LLC
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.
Age
15–45
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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
Clareo Health | Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
