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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Curcumin

Criteria

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