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Two-year performance of a Nestorone®-releasing contraceptive implant: a three-center study of 300 women

      Abstract

      A 2-year trial of a single Nestorone® (NES) rod implant was conducted at three Latin American centers, each enrolling 100 women. We studied the safety, effectiveness and acceptability of this progestin-releasing contraceptive implant. Three pregnancies occurred, the last at 18 months of use. Because no pregnancies were expected in the first 18 months, the trial was halted. At that time, 224 women had completed at least 18 months of use, and 99 women had used the implant for more than 24 months. Few participants used adjunctive contraception between the time the study was halted and the time they had their implant removed. No additional pregnancies occurred before the removal of the last implant. The 2-year cumulative pregnancy rate was 1.7 per 100 with a Pearl index of 0.6 per 100 for the 2-year period. The 1-year and 2-year continuation rates were 80.5 and 66.7 per 100, respectively. Menstrual and medical disturbances were the principal reasons for discontinuation, followed by planned pregnancy. Headache and weight gain frequently led to discontinuation. The NES implant had little important effect on most clinical chemistry and lipid parameters. Over the study course, the mean change in hemoglobin was <1%. Slight modification of the design of this single 2-year implant, restoring features previously examined in clinical trials, is likely to improve its effectiveness. A single NES implant appears to provide acceptable contraception for women.

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      References

        • Coutinho E.M.
        • Da Silva A.R.
        • Kraft H.G.
        Fertility control with subdermal Silastic capsules containing a new progestin (ST-1435).
        Int J Fertil. 1976; 21: 103-108
        • Coutinho E.
        Clinical experience with implant contraception.
        Contraception. 1978; 18: 411-427
        • Coutinho E.M.
        • da Silva A.R.
        • Carreira C.M.
        • Sivin I.
        Long-term contraception with a single implant of the progestin ST-1435.
        Fertil Steril. 1981; 36: 737-740
        • Lahteenmaki P.
        • Weiner E.
        • Lahteenmaki P.
        • Johansson E.
        • Luukkainen T.
        Contraception with subcutaneous capsules containing ST-1435. Pituitary and ovarian function and plasma levels of ST-1435.
        Contraception. 1981; 23: 63-75
        • Odlind V.
        • Lithell H.
        • Selinus I.
        • Vessby B.
        Unaltered lipoprotein and carbohydrate metabolism during treatment with contraceptive subdermal implants containing ST-1435.
        Ups J Med Sci. 1984; 89: 151-158
        • Kurunmaki H.
        • Toivonen J.
        • Lahteenmaki P.
        • Luukkainen T.
        Contraception with subdermal ST-1435 capsules.
        Contraception. 1985; 31: 305-318
        • Haukkamaa M.
        • Laurikka-Routti M.
        • Heikinheimo O.
        • Moo-Young A.
        Contraception with subdermal implants releasing the progestin ST-1435.
        Contraception. 1992; 45: 49-55
        • Laurikka-Routti M.
        Serum lipids, blood pressure, body weight, and serum chemistry in women using subcutaneous contraceptive implants releasing the progestin ST 1435.
        Obstet Gynecol. 1992; 80: 855-859
        • Laurikka-Routti M.
        • Haukkamaa M.
        A contraceptive subdermal implant releasing the progestin ST-1435.
        Fertil Steril. 1992; 58: 1142-1147
        • Diaz S.
        • Schiappacasse V.
        • Pavez M.
        • et al.
        Clinical trial with Nestorone™ subdermal contraceptive implants.
        Contraception. 1995; 51: 33-38
        • Heikinheimo O.
        • Noe G.
        • Haukkamaa M.
        • Lahteenmaki P.
        The progestin ST 1435—rapid metabolism in man.
        Contraception. 1994; 50: 275-289
        • Coutinho E.M.
        • Athayde C.
        • Dantas C.
        • Hirsch C.
        • Barbosa I.
        Use of a single implant of elcometrine (ST-1435), a nonorally active progestin, as a long acting contraceptive for postpartum nursing women.
        Contraception. 1999; 59: 115-122
        • Faundes A.
        • Alvarez F.
        • Brache V.
        • Cochon L.
        • Tejada A.S.
        • Moo-Young A.
        Correlation of endocrine profiles with bleeding patterns during use of Nestorone contraceptive implants.
        Hum Reprod. 1999; 14: 3013-3017
        • Brache V.
        • Massai R.
        • Mishell D.R.
        • et al.
        Ovarian function during use of Nestorone® subdermal implants.
        Contraception. 2000; 61: 199-204
        • Fraser I.S.
        • Weisberg E.
        • Minehan E.
        • Johansson E.D.
        A detailed analysis of menstrual blood loss in women using Norplant and Nestorone progestogen-only contraceptive implants or vaginal rings.
        Contraception. 2000; 61: 241-251
        • Croxatto H.B.
        Progestin implants.
        Steroids. 2000; 65: 681-685
        • Massai M.R.
        • Diaz S.
        • Quinteros E.
        • et al.
        Contraceptive efficacy and clinical performance of Nestorone implants in postpartum women.
        Contraception. 2001; 64: 369-376
        • Sivin I.
        • Moo-Young A.
        Recent developments in contraceptive implants at the Population Council.
        Contraception. 2002; 65: 113-119
        • Diaz S.
        Contraceptive implants and lactation.
        Contraception. 2002; 65: 39-46
        • Laurikka-Routti M.
        • Haukkamaa M.
        • Heikinheimo O.
        A contraceptive vaginal ring releasing ethinyl estradiol and the progestin ST-1435.
        Contraception. 1990; 42: 111-120
        • Alvarez-Sanchez F.
        • Brache V.
        • Jackanicz T.
        • Faundes A.
        Evaluation of four different contraceptive vaginal rings.
        Contraception. 1992; 46: 387-398
        • Brache V.
        • Alvarez-Sanchez F.
        • Faundes A.
        • Jackanicz T.
        • Mishell D.R.
        • Lahteenmaki P.
        Progestin-only contraceptive rings.
        Steroids. 2000; 65: 687-691
        • Massai R.
        • Diaz S.
        • Jackanicz T.
        • Croxatto H.B.
        Vaginal rings for contraception in lactating women.
        Steroids. 2000; 65: 703-707
        • Brache V.
        • Mishell D.R.
        • Lahteenmaki P.
        • et al.
        Ovarian function during use of vaginal rings delivering three different doses of Nestorone.
        Contraception. 2001; 63: 257-261
        • Harwood B.
        • Mishell D.R.
        Contraceptive vaginal rings.
        Semin Reprod Med. 2001; 19: 381-390
        • Haukkamaa M.
        • Laurikka-Routti M.
        • Heikinheimo O.
        Transdermal absorption of the progestin ST-1435.
        Contraception. 1991; 44: 269-276
        • Suhonen S.
        • Haukkamaa M.
        • Lahteenmaki P.
        • Holmstrom T.
        Endometrial effect of transdermal estradiol and progestin ST-1435 in postmenopausal women.
        Fertil Steril. 1992; 57: 1211-1215
        • Sitruk-Ware R.
        Transdermal application of steroid hormones for contraception.
        J Steroid Biochem Mol Biol. 1995; 53: 247-251