Clinical trial NCT04205929: Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
Official title: Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Implants
Breakthrough Bleeding
Keywords: Contraceptive implant
Irregular bleeding
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-12-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Total Number of Days Without Bleeding or Spotting
timeFrame: Day 1 to Day 30
Secondary outcomes:
measure: Total Number of Bleeding/Spotting Days
timeFrame: Day 1 to Day 30
measure: Total Number of Spotting Days
timeFrame: Day 1 to Day 30
measure: Total Number of Bleeding Days
timeFrame: Day 1 to Day 30
Other outcomes:
measure: Change in Patient Satisfaction With Bleeding Pattern as Assessed by VAS
timeFrame: Day 1 to Day 30
measure: Proportion of Participants Who Intend to Continue Use of Implant
timeFrame: Day 30
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References: