The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study

Abstract

A new contraceptive (LNG rod implants, Jadelle, Leiras Oy's registered trademark for rod implants) was prospectively evaluated in randomized 5 year comparison with Norplant (Population Council's registered trademark for contraceptive implants releasing levonorgestrel) capsule implants. The study involved 1198 women at seven centres. No pregnancies occurred in the first 4 years. At 5 years, the cumulative pregnancy rate was 1 per 100 users or less for each regimen. Annual discontinuation rates averaged 11-12 per 100 users (P > 0.05), corresponding to 5 year continuation rates of 55.1 for rods and 53.0 per 100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5 and 4.2 per 100 for rod and capsule implants respectively (P > 0.05), and mean annual removal rates for medical problems were 3.5 and 3.0 per 100 (P > 0.05) respectively. Apart from menstrual problems, headache, weight gain and acne were the principal medical reasons for removal. In proportional hazard analyses, family formation variables, age, parity and desire/non desire for another child, recorded at admission, significantly affected discontinuation rates for major decrement categories and for all reasons combined. Mean rod removal time was half that of Norplant (P < 0.01); complications of rod removal were at a lower rate. With these contraceptives indistinguishable in performance except for ease and speed of removal, LNG rod implants appear to be preferable to Norplant for use through 5 years by virtue of relative ease of removal.

New Zealand women’s experience during their first year of Jadelle® contraceptive implant

“…5,6 Study participants who continued to experience prolonged or irregular bleeding became increasingly dissatisfied over time. As with other studies, 5,7,8 bleeding problems were the most common reason for removal. Ten percent of participants stated that bleeding problems, either alone or with hormonal side effects, were the reason they sought removal of their implant.…”

“…5 At five years, 55% of women were still using the Jadelle® implant, giving a cumulative 5-year life table discontinuation rates for menstrual problems of 16.4/100. 7 More recent studies such as the Choice project had similar discontinuation rates to those of this study with 17% at 1 year for Implanon® users. 16 Total study discontinuation rates, made up of both known removals and loss to follow up rates, showed no difference between ethnicities and age.…”

Side effect profile of Jadelle implant in Nigerian women during the first 12 months of usage

“…4,23 However, studies in Asia showed significant weight gain in some clients warranting request for removal of the implant, while a study in Pakistan found significant increase in mean body weight of clients by the end of 2 years of usage. 23,28 There were a few non-menstrual side effects in Jadelle users in this study noted at 6months of usage, although the proportion of clients who had these side effects by the 12month of survey decreased, in agreement with similar studies elsewhere in the world. 4,25,26 Conversely, a different study found in addition more serious side effects like upper limb neuropathies, nervousness, visual disturbances, arthropathies, and non-clinical depression.…”

New technologies in contraception

“…54 Single-rod etonogestrel (3-keto desogestrel) in EVA polymer implants give an initial release rate of about 60 micrograms/day, which maintains serum levels well above those needed to inhibit ovulation (90 pg/ml) for 3 years. 55 They are inserted using a disposable applicator.…”