title: Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial.
abstract: OBJECTIVE
  Estimate symptom improvement rate of women with bleeding complaints using the etonogestrel contraceptive implant when started on continuous combined oral contraceptives (COC).
  
  
  METHODS
  We conducted a double-blinded randomised controlled trial of women reporting troublesome bleeding related to their etonogestrel contraceptive implant and desiring intervention. Participants received continuous COCs or placebo for four weeks to evaluate self-reported bleeding improvement at four weeks. Participants could continue study treatment or prescribed COCs for another eight weeks if desired. We planned to enroll 130 participants between two sites (80% power to detect a 20% effect size at a 0.05 significance level, with 10% loss to follow up).
  
  
  RESULTS
  We closed the study after enrolling 26 participants due to recruitment futility. All women on COCs and 75% of placebo users reported bleeding improvement at four weeks (p = 0.09), with 92% and 42%, respectively, reporting significant improvement (p = 0.03). The median number of days until bleeding stopped for at least four days in COC and placebo users was 1 day (range 1-9) and 4.5 days (range 1-28), respectively (p = 0.63). Eight (75%) COC and five (42%) placebo users opted to continue study treatment (p = 0.41). Despite bleeding improvement, women who desired implant removal at enrollment were more likely to re-request removal than those who initially considered other interventions (3 of 5 [60%] vs 1 of 17 [6%], p = 0.03).
  
  
  CONCLUSIONS
  Although women who have troublesome bleeding while using the contraceptive implant may experience improvement with no treatment over 4 weeks, women using COCs are more likely to report significant improvement. Clinicaltrials.gov registration number: NCT01963403.
authors.affiliation: a Department of Obstetrics and Gynecology , University of California, Davis , Sacramento , CA , USA ;
authors.forename: Melody Y
authors.initials: MY
authors.lastname: Hou
authors.affiliation: b Department of Obstetrics and Gynecology , Washington University in St. Louis School of Medicine , St. Louis , MO , USA.
authors.forename: Colleen
authors.initials: C
authors.lastname: McNicholas
authors.affiliation: a Department of Obstetrics and Gynecology , University of California, Davis , Sacramento , CA , USA ;
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Creinin
mesh_terms: D000293:Adolescent; D000328:Adult; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D003277:Contraceptives, Oral, Combined / Q000627:therapeutic use*; D017135:Desogestrel / Q000009:adverse effects*; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000139:chemically induced / Q000188:drug therapy*; D008796:Metrorrhagia / Q000139:chemically induced / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D004343:Drug Implants; C044815:etonogestrel; D017135:Desogestrel
keywords: Contraception; bleeding; combined oral contraceptive; etonogestrel; implant