Aim: We assessed bleeding
pattern, tolerance and patient satisfaction of an oral contraceptive
containing 3 mg drospirenone and 30 mcg ethinyl
estradiol (DRSP/EE) under real-life conditions. Study Design: We performed a multicenter, prospective,
6-cycle, observational study in Canada, Europe and the Middle East. Detailed
analyses of the three Middle East countries, Jordan, Lebanon andSyriawere
presented here. The efficacy variables included an assessment of bleeding
patterns, premenstrual symptoms of water retention and patient satisfaction,
as determined by a visual analogue scale. Results:
A total of914 women were enrolled. The percentage of women with intermenstrual
bleeding decreased from 37.4%,
48.7% and 32.2% at baseline to 9.7%, 6.1% and 10.9% at the end of cycle6 inJordan, Lebanon and Syria, respectively
(<0.0001). Also, the percentage of women with dysmenorrea decreased sharply in all three countries (p < 0.0001). Amenorrhea decreased significantly in Lebanon and Syria (p < 0.005).
In addition, signs of water retention like abdominal bloating, breast tenderness
and swelling of extremities decreased significantly over the course of 6
treatment cycles (p < 0.001). Patient satisfaction increased for all
investigated items. Upon completion of the study, 82.7% of women answered “Yes”
to continue treatment with this oral contraceptive. Conclusion: The oral contraceptive
containing 3 mg drospirenone and 30 mcg ethinyl estradiol has beneficial
effects on bleeding pattern, symptoms of water retention and patient satisfaction.
Cite this paper
Finan, R. , Annab, A. , Abdalla, S. , Bedran, F. , El-Zibdeh, M. , Shahen, L. , Gerlinger, C. , Solomayer, E. , Ertan, K. and Endrikat, J. (2013) A drospirenone-containing oral contraceptive improved bleeding pattern and personal satisfaction in 914 women from Jordan, Lebanon and Syria. Health, 5, 39-44. doi: 10.4236/health.2013.57A4006.
 Huber, J., Foidart, J.M., Wuttke, W., et al. (2000) Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. The European Journal of Contraception and Reproductive Health Care, 5, 25-34.
 Parsey, K.S. and Pong, A. (2000) An open-label, multi-centered study to evaluate Yasmin, a low-dose combination oral contraceptive containing drospirenone, a new progestogen. Contraception, 61, 105-111.
 Dinger, J.C., Heinemann, L.A. and Kühl-Habich, D. (2007) The safety of a drospirenone-containing oral contraceptive: Final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception, 75, 344-354.
 Muhn, P., Krattenmacher, R., Beier, S., et al. (1995) Drospirenone: A novel progestogen with antimineralocorticoid and antiandrogenic activity. Pharmacological characterization in animal models. Contraception, 51, 99-110.
 Foidart, J.M., Oelkers, W. and Heithecker, R. (1995) Drospirenone: A novel progestogen with antimineralocorticoid and antiandrogenic activity: A major breakthrough in tomorrow’s oral contraception. Gynecol Snapshot, 3, 13-17.
 Fuhrmann, U., Krattenmacher, R., Slater, E.P. and Fritzemeier, K.-H. (1996) The novel progestin drospirenone and its natural counterpart progesterone: Biochemical profile and antiandrogenic potential. Contraception, 54, 243-251.
 Oelkers, W., Foidart, J.-M., Dombrovicz, N., et al. (1995) Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the reninaldosterone system, body weight, blood pressure, glucose tolerance and lipid metabolism. The Journal of Clinical Endocrinology & Metabolism, 80, 1816-1821.
 Oelkers, W., Helmerhorst, F.M., Wuttke, W., et al. (2000) Effect of an oral contraceptive containing drospirenone on the renin-aldosterone system in healthy female volunteers. Gynecological Endocrinology, 14, 204-213.
 Endrikat, J., Milchev, N.P., Kapamadzija, A., Georgievska, J., Gerlinger, C., Schmidt, W. and Feroze, S. (2009) Bleeding pattern, tolerance and patient satisfaction with a drospirenone-containing oral contraceptive evaluated in 3488 women in Europe, the Middle East and Canada. Contraception, 79, 428-432.
 Foidart, J.M., Wuttke, W., Bouw, G.M., Gerlinger, C. and Heithecker, R. (2000) A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. The European Journal of Contraception and Reproductive Health Care, 5, 124-134.
 Moos, R.H. (1968) The development of a menstrual distress questionnaire. Psychosomatic Medicine, 30, 843-867.
 Moos, R.H. (1991) Menstrual distress questionnaire. Western Psychological Services. 12031 Wilshire Boulevard, Los Angeles.
 Endrikat, J., Sandri, M., Gerlinger, C., et al. (2007) A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 mcg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight. The European Journal of Contraception and Reproductive Health Care, 12, 220-228.
 Brown, C., Ling, F. and Wan, J. (2002) A new monophasic oral contraceptive containing drospirenone. Effect on premenstrual symptoms. The Journal of Reproductive Medicine, 47, 14-22.
 Fruzzetti, F., Lazzarini, V., Ricci, C., et al. (2007) Effect of an oral contraceptive containing 30 microg ethinylestradiol plus 3 mg drospirenone on body composition of young women affected by premenstrual syndrome with symptoms of water retention. Contraception, 76, 190-194. doi:10.1016/j.contraception.2007.05.080
 Fruzzetti, F., Lello, S., Lazzarini, V., et al. (2007) The oral contraceptive containing 30 microg of ethinylestradiol plus 3 mg of drospirenone is able to antagonize the increase of extracellular water occurring in healthy young women during the luteal phase of the menstrual cycle: An observational study. Contraception, 75, 199-203.
 Apter, D., Borsos, A., Baumgärtner, W., et al. (2003) Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms. The European Journal of Contraception and Reproductive Health Care, 8, 37-51.
 Borges, L.E., Andrade, R.P., Aldrighi, J.M., et al. (2006) Effect of a combination of ethinylestradiol 30 microg and drospirenone 3 mg on tolerance, cycle control, general wellbeing and fluid-related symptoms in women with premenstrual disorders requesting contraception. Contraception, 74, 446-450.