Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
Condition: Uterine Hemorrhage; Contraception
MeSH terms: Uterine Hemorrhage; Hemorrhage
Intervention: Combined Oral Contraceptive Pill; Placebo Sugar Pill
Intervention description: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill; Placebo Sugar Pill
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive
      implants who report a bleeding-spotting episode of at least seven days will stop bleeding
      within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to
      women receiving 14 days of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All female

          -  English or Spanish speaking women

          -  between the ages of 18-44

          -  using an ENG contraceptive implant who complain of bothersome bleeding and have a
             current bleeding episode of at least seven days will be invited to participate.

        Exclusion Criteria:

          -  Category 3 or 4 contraindications to estrogen therapy according to the Centers for
             Disease Control 2010 Medical Eligibility Criteria.

          -  Category 3 contraindications: less than 1 month postpartum if breastfeeding, less than
             21 days postpartum if not breastfeeding, history of Deep Vein Thrombosis (DVT)
             /Pulmonary Embolism (PE) not on anticoagulant therapy and no risk factors, Deep venous
             thrombosis/Pulmonary Embolus on established anticoagulant therapy and no risk factors,
             history of malabsorptive bariatric surgery, greater than or equal to months post
             peripartum cardiomyopathy with normal to mildly impaired cardiac function, greater
             than or equal to 35 years old with less than 15 cigarettes smoked per day, multiple
             risk factors for arterial cardiovascular disease, adequately controlled hypertension,
             blood pressure 140-159/90-99 mm Hg, migraines without aura less than 35 years old,
             past breast cancer and no evidence of recurrent disease for 5 years, diabetes with
             retinopathy, neuropathy, nephropathy (category 3 or 4 depending on severity), diabetes
             greater than 20 years duration or associated with other vascular disease, medically
             treated symptomatic gallbladder disease or current symptomatic gallbladder disease,
             past combined oral contraceptive pill related cholestasis, acute viral hepatitis,
             hepatocellular adenoma, hepatoma, use of ritonavir-boosted protease inhibitors,
             anticonvulsant therapy use including phenytoin, carbamazepine, barbiturates,
             primidone, topiramate, oxcarbazepine, and lamotrigine, use of Rifampicin,

          -  Category 4 contraindications: less than 6 months post peripartum cardiomyopathy with
             normal to mildly impaired cardiac function, any time following peripartum
             cardiomyopathy with moderately to severely impaired cardiac function, greater than or
             equal to 35 years old with greater than 15 cigarettes smoked per day, multiple risk
             factors for arterial cardiovascular disease, blood pressure greater than or equal to
             160/100 mm Hg, high risk for recurrent DVT/PE, acute DVT/PE, DVT/PE and on established
             anticoagulant therapy with greater than or equal to 1 risk factor for recurrent
             DVT/PE, major surgery/prolonged immobilization, known thrombogenic mutations, current
             and history of ischemic heart disease, history of stroke, complicated valvular heart
             disease, systemic lupus erythematosus (SLE) with positive or unknown antiphospholipid
             antibodies, migraines without aura greater than or equal to 35 years old, migraines
             with aura at any age, current breast cancer, complicated solid organ transplantation

          -  Body mass index (BMI) greater than 35.

          -  A systolic blood pressure greater than 135 on more than 2 occasions. assuring the
             measurements are separated by an interval of at least 15 minutes.

          -  A diastolic blood pressure greater than 85 on more than 2 occasions. assuring the
             measurement are separated by an interval of at least 15 minutes.

          -  A positive pregnancy test.

          -  A positive chlamydia test.

          -  Unable or unwilling to swallow pills.

          -  A medical condition deemed severed by a physician investigator.

          -  A participant taking a liver enzyme inducing drug.

          -  A known allergy to levonorgestrel or ethinyl estradiol.

          -  An abnormal speculum exam (i.e. bleeding ectropion or cervical mass).

          -  Does not meet appropriate cervical cytology screening guidelines.

          -  Cervical procedure done in the past 3 months.

          -  On a concurrent hormonal contraceptive and unwilling to discontinue.

          -  Breast lesions