Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Condition: Abnormal Uterine Bleeding, Unspecified; Uterine Bleeding Heavy
MeSH terms: Uterine Hemorrhage; Hemorrhage
Intervention: EE 30mcg/LNG 150mcg; Placebo
Intervention description: 1 pill per day; daily during study participation (up to 84 days); 1 pill per day; daily during study participation (up to 84 days)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: Female
Minimum age: 14 Years
Healthy volunteers: No
Keywords: etonogestrel implant; birth control; irregular bleeding; heavy bleeding

Summary:

      This double-blinded, placebo-controlled, randomized trial will compare the effects of the use
      of a combined oral contraceptive pill to a placebo pill for women who are experiencing
      irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.

      The hypothesis of the study is:

        -  Use of combined oral contraceptive will significantly improve bleeding patterns for
           users of ETG implant

        -  Continuation rate of ETG implant users will be increased by use of combined oral
           contraceptive in women desiring ETG implant removal because of the undesirable bleeding

        -  Adverse events will be uncommon and acceptable to women who use a combined oral
           contraceptive with the ETG implant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who have an ETG implant in place

          -  Women who subjectively experience the side effect of an undesirable bleeding profile
             such as bleeding irregularity or heavy flow after ETG implant was placed and who
             desire intervention for this side effect by either treatment of bleeding or removal of
             the implant

          -  Age 14 years an older, inclusive

        Exclusion Criteria:

          -  Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids,
             cervical polyp, or other organic cause of bleeding)

          -  Has attempted prescription treatment for menstrual side effects while using ETG
             implant

          -  Has one or more of the conditions considered Category 3 (risks outweigh benefits) or
             Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by
             the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:

               -  Current or history of heart or vascular diseases, including deep venous
                  thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum
                  cardiomyopathy, and complicated valvular heart disease

               -  Hypertension, even if adequately controlled

               -  Diabetes with vascular involvement

               -  Headaches with focal aura, or migraines in women age 35 and older even without
                  focal aura

               -  Major surgery with prolonged immobilization

               -  Breast cancer (current or past)

               -  Severe (decompensated) cirrhosis

               -  Acute or flare viral hepatitis

               -  Breastfeeding less than 1 month postpartum

               -  Post-partum less than 3 weeks

               -  35 years of age and older and smoking

               -  Multiple risk factors for arterial cardiovascular disease

               -  Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies

               -  Current symptomatic gallbladder disease or history of cholestasis related to past
                  combined oral contraceptive use

               -  On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone,
                  topiramate, oxcarbazepine, lamotrigine)

               -  On Ritonavir-boosted protease inhibitors for antiretroviral therapy

          -  Issues or concerns, in the judgment of the investigator, that may compromise the
             safety of the subject, impact the subject's adherence to the protocol requirements, or
             confound the reliability of the data acquired in this study