Menstrual cycle control, the efficacy and safety of a micro-dose monophasic combined oral contraceptive pill

Balan V.E., Tikhomirova E.V.

Moscow Regional Research Institute of Obstetrics and Gynecology, Moscow 101000, Pokrovka str. 22a, Russia
Objective. To determine the efficacy, safety, and control cycle of a low-dose monophasic combined oral contraceptive pill containing 20 µg ethinyl estradiol and 3 mg drospirenone, which is taken daily for 24 days, followed by a four-day hormone-free interval.
Subjects and methods. The investigation covered 40 women. In the first 2 months of taking the birth-control pill, only one (2.5%) woman was observed to have irregular intermenstrual bleeding that was not seen in the third cycle of its use.
Results. A dimia pill containing 20 µg of ethinyl estradiol plus 3 mg drospirenone in a 24+4 regimen has an excellent tolerability and high values of safety and acceptability. Most (92.5%) women reported that they would like to continue to use the test drug for the treatment of menstrual irregularities and for contraception.
Conclusion. The combination of 20 µg ethinyl estradiol and 3 mg drospirenone (dimia) taken daily for 24 days, followed by a four-day hormone-free interval (a 24+4 regimen) provides effective contraception and good cycle control.

Keywords

drospirenone
combined oral contraceptives
intermenstrual bleeding
dimia

Supplementary Materials

  1. Table 1. Extragenital diseases of the examined patients
  2. Table 2. General characteristics of the examined patients
  3. Table 3. Gynecological history of women in the study group
  4. Table 4. Dynamics of biochemical parameters of blood on the eve and against the background of reception of dimium
  5. Table 5. Adaptation effects recorded during the reception of dimia
  6. Table 6. Average duration of MNR on the background of reception of dimium

References

1. Kuznetsova I.V. Metabolic effects of combined hormonal contraception and a risk for thrombotic events. Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016; (6): 108-114. http://dx.doi.org/10.18565/aig.2016.6.108-114 (in Russian)

2. Tverdikova M.A., Gavisova A.A. Drospirenone – reliable contraception and non-contraceptive effects. RMJ. 2012; 20(1): 1-5. (in Russian)

3. Hatcher R.A., Trussell J., Stewart F., Cates W., Stewart G.K., Guest F. et al. eds. Contraceptive technology. 17th ed. NewYork: Ardent Media; 1998.

4. Shvarts S., Besinque K., Atkinson R., Gill M. New advances in contraception. Insights. 2002: 11-22.

5. Rosenberg M.J., Waugh M.S. Oral contraceptive discontinuation: a prospective evaluation off requency and reasons. Am. J. Obstet. Gynecol. 1998; 179(3, Pt 1): 577-82.

6. van Vloten W.A., van Haselen C.W., van Zuuren E.J., Gerlinger C., Heithecker R. The effect of 2 combined oral contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea. Cutis. 2002; 69(Suppl. 4): 2-15.

7. Sulak P.J., Scow R.D., Preece C., Riggs M.W., Kuehl T.J. Hormone withdrawal symptoms in oral contraceptive users. Obstet. Gynecol. 2000;95(2): 261-6.

8. Sulak P.J., Kuehl T.J., Ortiz M., Shull B.L. Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms. Am. J. Obstet. Gynecol. 2002; 186(6): 1142-9.

9. Akerlund M., Rode A., Westergaard J. Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. Br. J. Obstet. Gynaecol. 1993; 100(9): 832-8.

10. The Mircette Study Group. An open-label, multicenter, noncomparative safety and efficacy study of Mircette, a low-dose estrogen-progestin oral contraceptive. Am. J. Obstet. Gynecol. 1998; 179(1): S2-8.

11. Endrikat J., Düsterberg B., Ruebig A., Gerlinger C., Strowitzki T. Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. Contraception. 1999; 60(5): 269–74.

12. Anderson F.D., Hait H. A multicenter, randomized study of an extended cycle oral contraceptive. Contraception. 2003; 68(2): 89-96.

13. Boschitsch E., Skarabis H., Wuttke W., Heithecker R. The acceptability of a novel oral contraceptive containing drospirenone and its effect on well-being. Eur. J. Contracept. Reprod. Health Care. 2000; 5(Suppl. 3): 34-40.

14. Apter D., Borsos A., Baumgärtner W., Melis G.B., Vexiau-Robert D., Colligs-Hakert A. et al. Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms. Eur. J. Contracept. Reprod. Health Care. 2003; 8(1): 37-51.

15. Spona J., Elstein M., Feichtinger W., Sullivan H., Lüdicke F., Müller U., Düsterberg B. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996;54(2): 71-7.

16. Belsey E.M., Farley T.M. The analysis of menstrual bleeding patterns: a review. Contraception. 1988; 38(2): 129-56.

17. Bounds W., Vessey M., Wiggins P. A randomized double-blind trial of two low dose combined oral contraceptives. Br. J. Obstet. Gynaecol. 1979; 86(4): 325-9.

18. Archer D.F., Maheux R., DelConte A., O’Brien F.B. Efficacy and safety of a low-dosemonophasic combination oral contraceptive containing 100 microglevonorgestrel and 20 microgethinyl estradiol (Alesse). North American Levonorgestrel Study Group (NALSG). Am. J. Obstet. Gynecol. 1999;181(5, Pt 2): S39-44.

19. Borenstein J., Yu H.T., Wade S., Chiou C.F., Rapkin A. Effect of an oral contraceptive containing ethinyl estradiol and drospirenone on premenstrual symptomatology and health-related quality of life. J. Reprod. Med. 2003; 48(2): 79-83.

Received 07.02.2017

Accepted 17.02.2017

About the Authors

Balan Vera Efimovna, MD, professor, director of the outpatient department, Moscow Regional Research Institute of Obstetrics and Gynecology.
101000, Russia, Moscow, Pokrovka str. 22a
Tikhomirova Elena Vladislavovna, PhD, the highest category doctor, researcher of Moscow Regional Research Institute of Obstetrics and Gynecology.
101000, Russia, Moscow, Pokrovka str. 22a. E-mail: heltik03@gmail.com

For citations: Balan V.E., Tikhomirova E.V. Menstrual cycle control, the efficacy
and safety of a micro-dose monophasic combined oral contraceptive pill.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2017; (3): 124-9. (in Russian)
http://dx.doi.org/10.18565/aig.2017.3.124-9

Similar Articles

By continuing to use our site, you consent to the processing of cookies that ensure the proper functioning of the site.