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Cycle control with oral contraceptives containing 20 μg of ethinyl estradiol

A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 μg/20 μg) and norethindrone/ethinyl estradiol (1000 μg/20 μg)

      Abstract

      A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 μg levonorgestrel (LNG)/20 μg ethinyl estradiol (EE) (Aless®/Loette®) and 1000 μg norethindrone acetate (NETA)/20 μg EE (Loestrin Fe 1/20®) on menstrual cycle control over four cycles of use. A total of 84 evaluable women provided 274 cycles of exposure in the LNG/EE group, and 89 women provided 289 cycles of exposure in the NETA/EE group. Overall, the LNG/EE group achieved a consistently higher percentage of normal menstrual cycles as well as a lower rate of intermenstrual bleeding and amenorrhea than the NETA/EE group. In cycle 4, 63.8% of cycles were normal in the LNG/EE group compared with 41.9% in the NETA/EE group (p < 0.005). Of the total cycles in the NETA/EE group, 10% were amenorrheic, compared with 1.1% in the LNG/EE group. The occurrence of bleeding and/or spotting was significantly lower in cycles 2 and 3 in the LNG/EE group (41.7% and 34.8%, respectively) compared with the NETA/EE group (62.3% and 56.3%; p < 0.05). Other cycle variables were generally similar between groups, as was the incidence of adverse events. These results demonstrate that good cycle control was achieved with an OC containing 20 μg EE and that 100 μg LNG/20 μg EE produces better cycle control than 1000 μg NETA/20 μg EE.

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      References

        • Spona J
        • Feichtinger W
        • Kindermann C
        • et al.
        Inhibition of ovulation by an oral contraceptive containing 100 μg levonorgestrel in combination with 20 μg ethinylestradiol.
        Contraception. 1996; 54: 299-304
        • Archer D.F
        • Maheux R
        • DelConte A
        • O’Brien F.B
        A new low-dose monophasic combination oral contraceptive (Alesse™) with levonorgestrel 100 μg and ethinyl estradiol 20 μg.
        Contraception. 1997; 55: 139-144
        • Bannemerschult R
        • Hanker J.P
        • Wunsch C
        • et al.
        A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low-dose oral contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel over six treatment cycles.
        Contraception. 1997; 56: 285-290
        • Belsey E.M
        • Machin D
        • d’Arcangues C
        The analysis of vaginal bleeding patterns induced by fertility regulating methods.
        Contraception. 1986; 34: 253-260
        • Preston S.N
        A report of a collaborative dose-response clinical study using decreasing doses of combination oral contraceptives.
        Contraception. 1972; 6: 17-35
        • Wilde M.I
        • Balfour J.A
        Gestodene.
        Drugs. 1995; 50: 364-395
        • Van der Vange N
        Ovarian activity during low dose oral contraceptives.
        in: Chamberlain G Contemporary Obstetrics and Gynecology. Butterworth, London1988: 315-326
        • Fotherby K
        Pharmacokinetics and metabolism of progestins in humans.
        in: Goldzieher J.W Pharmacology of the Contraceptive Steroids. Raven Press, New York1994: 99-126
        • Back D.J
        • Bates M
        • Breckenridge A.M
        • et al.
        The pharmacokinetics of levonorgestrel and ethinyl estradiol in women—studies with Ovral® and Ovranette.®.
        Contraception. 1981; 23: 229-239
        • Back D.J
        • Breckenridge A.M
        • Crawford F.E
        • et al.
        Kinetics of norethindrone in women.
        Clin Pharmacol Ther. 1978; 24: 448-453
        • Rosenberg M.J
        • Long S.C
        Oral contraceptives and cycle control.
        Adv Contracept. 1992; 8: 35-45
        • DelConte A
        • Martin D.J
        • Gast M.J
        A multicenter, randomized, comparative trial of the effects on cycle control of two 21-day oral contraceptive regimens.
        Eur J Contracept Reprod Health Care. 1998; 3 (abst): 49
        • Appel T.B
        • Kambi A.A
        • Birdsall C
        • et al.
        A comparison of a new graduated estrogen formulation with three-constant-dosed oral contraceptives.
        Contraceptives. 1987; 35: 523-532
        • Rosenberg M.J
        • Waugh M.S
        • Meehan T.E
        Use and misuse of oral contraceptives.
        Contraception. 1995; 51: 283-288
        • Rosenberg M.J
        • Waugh M.S
        • Long S
        Unintended pregnancies and use, misuse and discontinuation of oral contraceptives.
        J Reprod Med. 1995; 40: 355-360
        • WHO Scientific Group
        Steroid Contraception and the Risk of Neoplasia. Technical Report Series No. 619. World Health Organization, Geneva1978