Clinical Study of the Triphasic Oral Contraceptive PillContaining Norgestimat 180/215/250 m mg andEthinylestradiol 35 m mg in Population of the CzechWomen

Overview

Objective:
To assess the efficacy, acceptability and safety of triphasic oral contraceptive pillcontaining norgestimate 180/215/250 mg and ethinylestradiol 35 mg.Design and setting: Prospective, open-label, non-comparative, multicenter study in 409 centers inthe Czech Republic.Methods: Body weight, blood pressure, bleeding pattern, headaches, nausea, breast tenderness,acne, pregnancies and side effects were monitored before the start of the treatment, after threeand six cycles of oral contraceptive use. Liver function tests were carried out before and after thetreatment.Results: Evaluating 26.432 cycles in 4.720 women the theoretical Pearl index was 0.15. There wereno significant changes in body weight (61.45 kg before vs 61.58 kg after the treatment). Therewere clinically significant changes neither in the blood pressure nor in the liver function tests.Evaluating the bleeding pattern there were similar incidences of irregular bleeding/spotting befo-re the treatment and up to the third treatment cycle (16.15%, resp. 17.86%); then the incidencedropped down (8.41% after the third cycle). Amenorhea was very rare (0.41% resp. 0.35% up to,resp. after the third cycle). Decreasing incidences compared to pretreatment state were observedfor headache, breast tenderness and acne. The effect on acne was remarkable (28.3% of womencomplaining of acne before the treatment vs 6.51% after the six treatment cycles). There were noserious adverse events observed during this study.Conclusion: Triphasic oral contraceptive pill containing norgestimate and ethinylestradiol pro-ved in a large multicenter study high both efficacy and acceptability.

Key words:
oral contraceptives, Norgestimate, Ethinylestradiol, efficacy, acceptability, bleedingpattern