Management of Etonogestrel Subdermal Implant-related Bleeding
Condition: ESI-related Bleeding
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blinded, randomized, prospective placebo-controlled clinical trial to be
      conducted within the Mayo Clinic and the Mayo Clinic Health System.

      The goal of the research study is to gather information to determine whether Doxycycline is
      effective for the treatment of unacceptable bleeding associated with the etonogestrel
      subdermal implant (ESI), as compared to placebo.
    

Detailed description: 
      ESI is a long-acting reversible contraceptive. Though safety and efficacy have been
      established world wide, only about 1 % of women have been reported to use this method. Its
      use is limited by bleeding pattern changes which result in requests for early removal, most
      commonly within the first 8 months of use.

      Women ages 18-51 years, choosing ESI and who meet eligibility criteria, will be offered
      enrollment in the study at the time of ESI insertion. Every effort will be made to insert
      Implanon on the same day as consent unless medically contraindicated. Prospective diaries
      will be completed starting on the date of ESI insertion. All participants will be contacted
      by study personnel 13 weeks after enrollment and queried as to the presence of unacceptable
      bleeding. Bleeding concerns will be objectively assessed using a modification of the
      Pictorial Blood Loss Assessment Chart (PBLAC).

      Participants initiating contact with bleeding concerns at any time after 13 weeks post-ESI
      insertion will be offered treatment randomization at the time of contact. The basis for
      randomized treatment will be whether the bleeding is considered "unacceptable" to the
      participant. This is inherently subjective, but constitutes the basis for most removal
      requests. Participants that report unacceptable bleeding at 13 weeks post-ESI insertion, and
      those who call with bleeding concerns anytime after 13 weeks post-ESI insertion, will be
      randomized into one of two groups, Doxycycline or matching placebo.

      Participants that do not report unacceptable bleeding will continue to complete diaries and
      may be eligible for randomized treatment if unacceptable bleeding develops.
    

Intervention name(s): Doxycycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.; Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
Other intervention name(s): Adoxa, Alodox, Avidoxy, Bio-Tab, Doryx, Doxy Lemmon, Doxy-Caps, Monodox, Morgidox, Ocudox, Oracea, Oraxyl, Periostat, Vibra-Tabs, Vibramycin; Sugar pill
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Implanon; Etonogestrel subdermal implant; Nexplanon; Contraception; Irregular Bleeding; Menometrorrhagia