Efficacy, safety and sustainability of treatment continuation and results of an oral contraceptive containing 30 mcg ethinyl estradiol and 2 mg chlormadinone acetate, in long-term usage (up to 45 cycles) - an open-label, prospective, noncontrolled, office-based Phase III study

Contraception

Volumn 77, Issue 5, 2008, Pages 337-343

  Zahradnik, Hans Peter ^a   Hanjalic Beck, Aida ^a  

^a UNIVERSITY OF FREIBURG   (Germany)

Author keywords

Antiandrogenic efficacy; Cardiovascular safety; Cervical cancer risk; Cycle control; EE 30 mcg+CMA 2 mg; Oral contraception

Indexed keywords

CHLORMADINONE ACETATE PLUS ETHINYLESTRADIOL;

ACNE; ADULT; ALOPECIA; AMENORRHEA; ARTICLE; ATHEROSCLEROSIS; BREAKTHROUGH BLEEDING; CARBOHYDRATE METABOLISM; CLINICAL TRIAL; DEPRESSION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EXCITABILITY; FATIGUE; FEMALE; FLU LIKE SYNDROME; FLUOR; HEADACHE; HEMOSTASIS; HIRSUTISM; HUMAN; INCIDENCE; LONG TERM CARE; MAJOR CLINICAL STUDY; MASTALGIA; MEAN ARTERIAL PRESSURE; NAUSEA; OPEN STUDY; ORAL CONTRACEPTION; OVARY CYST; PHASE 3 CLINICAL TRIAL; PULSE RATE; SEBORRHEA; SIDE EFFECT; THROMBOEMBOLISM; UTERINE CERVIX CANCER; VAGINA DISCHARGE; VERTIGO; VIRILIZATION; VOMITING; WITHDRAWAL BLEEDING;

ADULT; CHLORMADINONE ACETATE; CONTRACEPTIVES, ORAL, COMBINED; CONTRACEPTIVES, ORAL, SYNTHETIC; ETHINYL ESTRADIOL; FEMALE; HUMANS; TIME FACTORS; TREATMENT OUTCOME;

EID: 41549091883     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2007.12.007     Document Type: Article

References (24)

1. Bettendorf G., Breckwoldtt M., Keller P.J., Kuhl H., and Runnebaum B. Recommendations on oral contraception. Der Frauenarzt 38 (1997) 1058-1062
2. Mall-Haefeli M. In: Loch E.G., and Schramm G. (Eds). Die Wirkung der androgene auf das zyklusgeschehen chlormadinonacetat bei androgenisierungserscheinungen (1995), Schattauer, Stuttgart 43-55
3. Breckwoldt M., Zahradnik H., and Wieacker P. Hirsutism its pathogenesis. Hum Reprod 4 (1989) 601-604
4. Breckwoldtt M., Zahradnik H., and Wieacker P. In: Orfanos C., and Happle R. (Eds). Hirsutism (1990), Springer-Verlag, Berlin 777-789
5. Kaiser E. Effect of a new hormonal contraceptive (Neo-eunomin) in females with androgenization symptoms. Geburtshilfe Frauenheilkd 44 (1984) 651-655
6. Kuhl H. In: Loch E.G.S.G. (Ed). Chemie und pharmakologie von chlormadinonacetat chlormadinonacetat bei androgenisierungserscheinungen (1995), Schattauer, Stuttgart 1-16
7. Basdevant A., Conard J., Pelissier C., et al. Hemostatic and metabolic effects of lowering the ethinyl-estradiol dose from 30 mcg to 20 mcg in oral contraceptives containing desogestrel. Contraception 48 (1993) 193-204
8. Schramm G., and Steffens D. Contraceptive efficacy and tolerability of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (Belara®). Results of a post-marketing surveillance study. Clin Drug Invest 22 (2002) 221-231
9. Schramm G., and Steffens D. A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties. Contraception 67 (2003) 305-312
10. Zahradnik H., Goldberg J., and Andreas J. Efficacy and safety of the new antiandrogenic oral contraceptive Belara. Contraception 57 (1998) 103-109
11. Worret I., Arp W., Zahradnik H., Andreas J., and Binder N. Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon). Dermatology 203 (2001) 38-44
12. Pearl R. Contraception and fertility in 2000 women. Hum Biol 4 (1932) 263-407
13. Runnebaum B., and Rabe T. Gynäkologische endokrinologie (1994), Springer-Verlag, Berlin
14. Huber J., Foidart J., Wuttke W., et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care 5 (2000) 25-34
15. Parsey K., and Pong A. An open-label, multicenter study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception 61 (2000) 105-111
16. Endrikat J., Cronin M., Gerlinger C., Ruebig A., Schmidt W., and Dusterberg B. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 mcg ethinyl estradiol and 75 mcg gestodene and a 21-day regimen with 20 mcg ethinyl estradiol and 150 mcg desogestrel. Contraception 64 (2001) 201-207
17. Speroff L., and DeCherney A. Evaluation of a new generation of oral contraceptives. The Advisory Board for the New Progestins. Obstet Gynecol 81 (1993) 1034-1047
18. Stone S. Clinical review of a monophasic oral contraceptive containing desogestrel and ethinyl estradiol. Int J Fertil Menopausal Stud 38 Suppl 3 (1993) 117-121
19. Fotherby K. Twelve years of clinical experience with an oral contraceptive containing 30 micrograms ethinylestradiol and 150 micrograms desogestrel. Contraception 51 (1995) 3-12
20. Foidart J., Wuttke W., Bouw G., Gerlinger C., and Heithecker R. 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 5 (2000) 124-134
21. Aznar-Ramos R., Ginger-Velazquez J., Lara-Ricalde R., and Martinez-Manautou J. Incidence of side effects with contraceptive placebo. Am J Obstet Gynecol 105 (1969) 1144-1149
22. Gaspard U. Clinical relevance of plasma lipid changes during use of new low-dose oral contraceptives. Adv Contracept 7 (1991) 180-194
23. Rosenberg M., and Waugh M. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol 179 3 Pt 1 (1998) 577-582
24. Schramm G., and Heckes B. Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study. Contraception 76 (2007) 84-90