Skip to main content
Erschienen in: Clinical Drug Investigation 8/2011

01.08.2011 | Original Research Article

Cycle Control and Bleeding Pattern of a 24/4 Regimen of Drospirenone 3 mg/Ethinylestradiol 20 μg Compared with a 21/7 Regimen of Desogestrel 150 μg/Ethinylestradiol 20 μg

A Pooled Analysis

verfasst von: Dr Leena Anttila, Walter Neunteufel, Felice Petraglia, Joachim Marr, Michael Kunz

Erschienen in: Clinical Drug Investigation | Ausgabe 8/2011

Einloggen, um Zugang zu erhalten

Abstract

Background and Objective: The degree of cycle control achieved with a hormonal contraceptive method is an important determinant of its acceptance and continuation. This study set out to compare the cycle control and bleeding profile of drospirenone (DRSP) 3 mg/ethinylestradiol (EE) 20 μg in a 24-active pill/4-inert pill (24/4) regimen (YAZ®) with those of desogestrel (DSG) 150 ®g/EE 20 ®g in a 21/7 regimen (Mercilon®), an established European combined oral contraceptive (COC).
Methods: Bleeding data from women aged 17–36 years who received either DRSP 3 mg/EE 20 μg in a 24/4 regimen (n= 1285) or DSG 150 μg/EE 20 μg in a 21/7 regimen (n = 471) during four clinical studies were pooled and analysed over seven treatment cycles.
Results: The maximum intensity of scheduled withdrawal bleeding was ‘normal bleeding’ for >50% of subjects in cycles 1–6 in both treatment groups. Moreover, the incidence of unscheduled intracyclic bleeding during cycles 2–7 was comparable between treatment types (10.2–14.9% in women treated with DRSP 3 mg/EE 20 μg 24/4 vs 8.6–13.8% in women treated with DSG 150 μg/EE 20 μg 21/7). Overall, similar bleeding patterns were observed with both treatments.
Conclusion: DRSP 3 mg/EE 20 μg 24/4 is associated with a bleeding profile and cycle control that is comparable to that of an established, low-dose COC formulation.
Literatur
1.
Zurück zum Zitat Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol 1998; 179: 577–82CrossRefPubMed Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol 1998; 179: 577–82CrossRefPubMed
2.
Zurück zum Zitat Rosenberg MJ, Long SC. Oral contraceptives and cycle control: a critical review of the literature. Adv Contracept 1992; 8: 35–45CrossRefPubMed Rosenberg MJ, Long SC. Oral contraceptives and cycle control: a critical review of the literature. Adv Contracept 1992; 8: 35–45CrossRefPubMed
3.
Zurück zum Zitat Thorneycroft H, Gollnick H, Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 2004; 74: 123–30PubMed Thorneycroft H, Gollnick H, Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 2004; 74: 123–30PubMed
4.
Zurück zum Zitat Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of a unique progestogen. Contraception 2000; 62: 29–38CrossRefPubMed Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of a unique progestogen. Contraception 2000; 62: 29–38CrossRefPubMed
5.
Zurück zum Zitat Foidart JM, Wuttke W, Bouw GM, et al. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care 2000; 5: 124–34CrossRefPubMed Foidart JM, Wuttke W, Bouw GM, et al. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care 2000; 5: 124–34CrossRefPubMed
6.
Zurück zum Zitat Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care 2000; 5: 25–34CrossRefPubMed Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care 2000; 5: 25–34CrossRefPubMed
7.
Zurück zum Zitat Bachmann G, Sulak PJ, Sampson-Landers C, et al. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception 2004; 70: 191–8CrossRefPubMed Bachmann G, Sulak PJ, Sampson-Landers C, et al. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception 2004; 70: 191–8CrossRefPubMed
8.
Zurück zum Zitat Koltun W, Lucky AW, Thiboutot D, et al. Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebocontrolled trial. Contraception 2008; 77: 249–56CrossRefPubMed Koltun W, Lucky AW, Thiboutot D, et al. Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebocontrolled trial. Contraception 2008; 77: 249–56CrossRefPubMed
9.
Zurück zum Zitat Lucky AW, Koltun W, Thiboutot D, et al. A combined oral contraceptive containing 3-mg drospirenone/20-microg ethinyl estradiol in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled study evaluating lesion counts and participant self-assessment. Cutis 2008; 82: 143–50PubMed Lucky AW, Koltun W, Thiboutot D, et al. A combined oral contraceptive containing 3-mg drospirenone/20-microg ethinyl estradiol in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled study evaluating lesion counts and participant self-assessment. Cutis 2008; 82: 143–50PubMed
10.
Zurück zum Zitat Maloney JM, Dietze P, Watson D, et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112: 773–81CrossRefPubMed Maloney JM, Dietze P, Watson D, et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112: 773–81CrossRefPubMed
11.
Zurück zum Zitat Pearlstein TB, Bachmann GA, Zacur HA, et al. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 2005; 72: 414–21CrossRefPubMed Pearlstein TB, Bachmann GA, Zacur HA, et al. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 2005; 72: 414–21CrossRefPubMed
12.
Zurück zum Zitat Yonkers KA, Brown C, Pearlstein TB, et al. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol 2005; 106: 492–501CrossRefPubMed Yonkers KA, Brown C, Pearlstein TB, et al. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol 2005; 106: 492–501CrossRefPubMed
13.
Zurück zum Zitat Anttila L, Kunz M, Marr J. Bleeding pattern with drospirenone 3 mg + ethinylestradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg + ethinylestradiol 20 mcg 21/7 combined oral contraceptive. Contraception 2009; 80: 445–51CrossRefPubMed Anttila L, Kunz M, Marr J. Bleeding pattern with drospirenone 3 mg + ethinylestradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg + ethinylestradiol 20 mcg 21/7 combined oral contraceptive. Contraception 2009; 80: 445–51CrossRefPubMed
14.
Zurück zum Zitat Gruber DM, Huber JC, Melis GB, et al. A comparison of the cycle control, safety, and efficacy profile of a 21-day regimen of ethinylestradiol 20 mcg and drospirenone 3 mg with a 21-day regimen of ethinylestradiol 20 mcg and desogestrel 150mcg. Treat Endocrinol 2006; 5: 115–21CrossRefPubMed Gruber DM, Huber JC, Melis GB, et al. A comparison of the cycle control, safety, and efficacy profile of a 21-day regimen of ethinylestradiol 20 mcg and drospirenone 3 mg with a 21-day regimen of ethinylestradiol 20 mcg and desogestrel 150mcg. Treat Endocrinol 2006; 5: 115–21CrossRefPubMed
15.
Zurück zum Zitat Klipping C, Marr J. Effects of two combined oral contraceptives containing ethinyl estradiol 20 microg combined with either drospirenone or desogestrel on lipids, hemostatic parameters and carbohydrate metabolism. Contraception 2005; 71: 409–16CrossRefPubMed Klipping C, Marr J. Effects of two combined oral contraceptives containing ethinyl estradiol 20 microg combined with either drospirenone or desogestrel on lipids, hemostatic parameters and carbohydrate metabolism. Contraception 2005; 71: 409–16CrossRefPubMed
16.
Zurück zum Zitat Belsey EM, Machin D, d’Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception 1986; 34: 253–60CrossRefPubMed Belsey EM, Machin D, d’Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception 1986; 34: 253–60CrossRefPubMed
17.
Zurück zum Zitat Kirkman RJ, Pederse JH, Fioretti P, et al. Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age. Contraception 1994; 49: 33–46CrossRefPubMed Kirkman RJ, Pederse JH, Fioretti P, et al. Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age. Contraception 1994; 49: 33–46CrossRefPubMed
18.
Zurück zum Zitat Lammers P, op ten Berg M: Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. Acta Obstet Gynecol Scand 1991; 70: 497–500CrossRefPubMed Lammers P, op ten Berg M: Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. Acta Obstet Gynecol Scand 1991; 70: 497–500CrossRefPubMed
19.
Zurück zum Zitat Endrikat J, Cronin M, Gerlinger C, et al. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 75 microg gestodene and a 21-day regimen with 20 microg ethinyl estradiol and 150 microg desogestrel. Contraception 2001; 64: 201–7CrossRefPubMed Endrikat J, Cronin M, Gerlinger C, et al. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 75 microg gestodene and a 21-day regimen with 20 microg ethinyl estradiol and 150 microg desogestrel. Contraception 2001; 64: 201–7CrossRefPubMed
20.
Zurück zum Zitat Endrikat J, Cronin M, Gerlinger C, et al. Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day versus a 21-day low-dose oral contraceptive regimen containing 20 microg ethinyl estradiol and 75 microg gestodene. Contraception 2001; 64: 99–105CrossRefPubMed Endrikat J, Cronin M, Gerlinger C, et al. Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day versus a 21-day low-dose oral contraceptive regimen containing 20 microg ethinyl estradiol and 75 microg gestodene. Contraception 2001; 64: 99–105CrossRefPubMed
21.
Zurück zum Zitat Kaunitz AM, Burkman RT, Fisher AC, et al. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol 2009; 114: 1205–12CrossRefPubMed Kaunitz AM, Burkman RT, Fisher AC, et al. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol 2009; 114: 1205–12CrossRefPubMed
22.
Zurück zum Zitat Mishell Jr DR, Guillebaud J, Westhoff C, et al. Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception. Contraception 2007; 75: 4–10CrossRefPubMed Mishell Jr DR, Guillebaud J, Westhoff C, et al. Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception. Contraception 2007; 75: 4–10CrossRefPubMed
23.
Zurück zum Zitat Archer DF, Maheux R, DelConte A, et al. A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms. North American Levonorgestrel Study Group (NALSG). Contraception 1997; 55: 139–44CrossRefPubMed Archer DF, Maheux R, DelConte A, et al. A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms. North American Levonorgestrel Study Group (NALSG). Contraception 1997; 55: 139–44CrossRefPubMed
24.
Zurück zum Zitat Archer DF, Maheux R, DelConte A, et al. Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 microg levonorgestrel and 20 microg ethinyl estradiol (Alesse). North American Levonorgestrel Study Group (NALSG). Am J Obstet Gynecol 1999; 181: 39–44CrossRefPubMed Archer DF, Maheux R, DelConte A, et al. Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 microg levonorgestrel and 20 microg ethinyl estradiol (Alesse). North American Levonorgestrel Study Group (NALSG). Am J Obstet Gynecol 1999; 181: 39–44CrossRefPubMed
25.
Zurück zum Zitat Parsey KS, Pong A. An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception 2000; 61: 105–11CrossRefPubMed Parsey KS, Pong A. An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception 2000; 61: 105–11CrossRefPubMed
26.
Zurück zum Zitat Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception 1996; 54: 71–7CrossRefPubMed Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception 1996; 54: 71–7CrossRefPubMed
27.
Zurück zum Zitat Sullivan H, Furniss H, Spona J, et al. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microg) and ethinyl estradiol (15 microg) on ovarian activity. Fertil Steril 1999; 72: 115–20CrossRefPubMed Sullivan H, Furniss H, Spona J, et al. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 microg) and ethinyl estradiol (15 microg) on ovarian activity. Fertil Steril 1999; 72: 115–20CrossRefPubMed
Metadaten
Titel
Cycle Control and Bleeding Pattern of a 24/4 Regimen of Drospirenone 3 mg/Ethinylestradiol 20 μg Compared with a 21/7 Regimen of Desogestrel 150 μg/Ethinylestradiol 20 μg
A Pooled Analysis
verfasst von
Dr Leena Anttila
Walter Neunteufel
Felice Petraglia
Joachim Marr
Michael Kunz
Publikationsdatum
01.08.2011
Verlag
Springer International Publishing
Erschienen in
Clinical Drug Investigation / Ausgabe 8/2011
Print ISSN: 1173-2563
Elektronische ISSN: 1179-1918
DOI
https://doi.org/10.2165/11590260-000000000-00000

Weitere Artikel der Ausgabe 8/2011

Clinical Drug Investigation 8/2011 Zur Ausgabe