Contraception Clinical Trial
Official title:
Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
The investigators' specific aims are to determine if more women using 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 etonogestrel (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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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