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

OHSU IRB 20645

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.

2020-04-15

2022-11-05

2023-08-01

Completed

Early phase I

58

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Placebo-controlled Computer-generated randomization schema', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}

2024-07-03