August 19th, 2017

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Evaluation of the Presence and Persistence of Ovarian Cysts in Users of a New Low-Dose Levonorgestrel-Releasing Intrauterine Contraceptive System over 5 Years
Authors:  Gerard G. Nahum, M.D., FACOG, FACS, Andrew M. Kaunitz, M.D., FACOG, Eeva Lukkari-Lax, M.D., Ph.D., Thomas Schmelter, Ph.D., and Kimberly Rosen, M.D.
  OBJECTIVE: To assess presence and persistence of ovarian cysts in users of a new levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 12 [12 μg average daily release rate over 1 year, 19.5 mg total content]).

STUDY DESIGN: A phase 3 study assessed the efficacy and safety of LNG-IUS 12 use in healthy women requesting contraception. Ultrasonography was performed at screening, baseline, and periodically for up to 5 years. Ovarian cysts were defined as cystic structures >30 mm in diameter and/or not having the appearance of a follicle.

RESULTS: A total of 13,306 transvaginal ultrasounds were performed in 1,452 women (mean age, 27.1 years). Cysts were imaged in 1.6% of women at screening. Thereafter, the presence of cysts was 1.5–4.8%. In all, 170 incident cysts were imaged from baseline through month 9; 78% of those measured >30 to ≤50 mm. Persistence from one examination to the next during year 1 was 9.4% (15/159), with baseline to 3 months=16%, 3–6 months=12%, 6–9 months=9%, and 9–12 months= 4%. Persistence was higher for cysts >50 mm (17%).

CONCLUSION: Ovarian cysts were present in 1.6% of women at screening, 3.0–4.8% of LNG-IUS 12 users during year 1, and 1.9–3.4% during years 2–5. The majority were >30 to ≤50 mm. The small and diminishing number of persistent cysts suggests the majority were functional and not clinically relevant.
Keywords:  contraception; intrauterine contraception; intrauterine devices; intrauterine devices, medicated; intrauterine system; levonorgestrel; medicated intrauterine devices; ovarian cysts
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