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.
The ENG contraceptive implant (Implanon/Nexplanon®), is a silicone- free, single rod subdermal contraceptive implant that contains 68 mg of etonogestrel, is approved for use for three years, and is one of the most effective forms of contraception available (1). ENG contraceptive implants are easily inserted and removed (1,2), offer quick return to fertility (2), are cost-effective and cost-saving (3,4) and offer non-contraceptive benefits such as improvement in pain for patients with complaints of dysmenorrhea (5). Hypothesis: Women using ENG contraceptive implants who report a bleeding-spotting episode of at least seven days will be more likely to stop bleeding within 3 days of beginning a 14-day course of combined oral hormonal steroids compared to women receiving 14 days of placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
Placebo Sugar Pill
University of Colorado
Aurora, Colorado, United States
Cessation of Vaginal Bleeding
Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.
Time frame: At day 3 of 14 day course of study drug
Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred
Time frame: over the 14 day course of study drug
Number of Days Without Bleeding During Therapy
Time frame: Over the 14 day course of study drug
Number of Days to Recurrence of Bleeding After Discontinuation of Therapy
Time frame: Up to six months
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