Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Condition: Bleeding; Implants; Breakthrough Bleeding
MeSH terms: Metrorrhagia; Hemorrhage
Intervention: Tamoxifen; Placebo; Tamoxifen (open label)
Intervention description: Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study; Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study; Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
Intervention MeSH terms: Tamoxifen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Unscheduled bleeding; Long acting contraception

Summary:

      The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective
      method of preventing pregnancy, but it has bleeding side effects that make it unappealing for
      many women. The only study to demonstrate a sustained reduction in bleeding lasting for two
      months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the
      levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary
      data of tamoxifen and ENG implant users, the investigators plan to perform additional studies
      on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking

          -  women aged 15-45 years of age

          -  Currently using the ENG-implant for at least 1 month and use proven on exam (palpation
             of implant at screening visit)

          -  Willing to continue using the implant for at least 6 months

          -  >7 days of continuous bleeding/spotting, or 2 or more episodes of bleeding/spotting in
             the last 30 days.

          -  Cellphone that is able to receive and respond to a daily text or email message .

        Exclusion Criteria:

          -  Postpartum within six months

          -  post-abortion within six weeks

          -  currently pregnant

          -  currently breast-feeding

          -  undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant

          -  bleeding dyscrasia

          -  anticoagulation use

          -  active cervicitis

          -  allergy to tamoxifen

          -  history of venous thromboembolism

          -  current or past breast or uterine malignancy

          -  use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine,
             rifampicin, aminoglutethimide, phenobarbital).