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An open-label randomized comparative study of oral contraceptives between medications containing 3 mg drospirenone/30 microg ethinylestradiol and 150 microg levonogestrel/30 microg ethinylestradiol in Thai women.

Abstract

This study was conducted to compare the cycle control, efficacy and adverse events of a new low-dose oral contraceptive pill regimen containing 3 mg drospirenone (DRSP)/30 microg ethinylestradiol (EE), with a widely prescribed 150 microg levonogestrel (LNG)/30 microg EE. The results of this comparative trial demonstrated that the two preparations had no statistically significant difference in terms of cycle control, efficacy and adverse events. The occurrence of spotting and breakthrough bleeding was low and was not different between the two regimens. There was neither amenorrhea nor pregnancies reported in either group. The most common adverse events in both groups were nausea, headache and breast tenderness. Also statistically significant changes were found in body weight and blood pressure in both groups at the end of the study. In conclusion, the 3 mg DRSP/30 microg EE regimen provides good cycle control with reliable contraceptive efficacy and a low incidence of adverse events equal to the 150 microg LNG/30 microg EE preparation. Compared with the 150 microg LNG/30 microg EE preparation, the 3 mg DRSP/30 microg EE preparation demonstrated a more favorable effect on body weight and blood pressure, with the mean body weight and mean blood pressure remaining lower than baseline mean. The new formulation may be especially beneficial for women susceptible to body weight gain and rise in blood pressure.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Obstetrics and Gynecology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand.

    Source

    Contraception 69:1 2004 Jan pg 23-6

    MeSH

    Adolescent
    Adult
    Androstenes
    Blood Pressure
    Body Weight
    Contraceptives, Oral, Combined
    Ethinyl Estradiol
    Female
    Humans
    Levonorgestrel
    Menstrual Cycle
    Thailand

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    14720615

    Citation

    Suthipongse, Wichit, and Surasak Taneepanichskul. "An Open-label Randomized Comparative Study of Oral Contraceptives Between Medications Containing 3 Mg Drospirenone/30 Microg Ethinylestradiol and 150 Microg Levonogestrel/30 Microg Ethinylestradiol in Thai Women." Contraception, vol. 69, no. 1, 2004, pp. 23-6.
    Suthipongse W, Taneepanichskul S. An open-label randomized comparative study of oral contraceptives between medications containing 3 mg drospirenone/30 microg ethinylestradiol and 150 microg levonogestrel/30 microg ethinylestradiol in Thai women. Contraception. 2004;69(1):23-6.
    Suthipongse, W., & Taneepanichskul, S. (2004). An open-label randomized comparative study of oral contraceptives between medications containing 3 mg drospirenone/30 microg ethinylestradiol and 150 microg levonogestrel/30 microg ethinylestradiol in Thai women. Contraception, 69(1), pp. 23-6.
    Suthipongse W, Taneepanichskul S. An Open-label Randomized Comparative Study of Oral Contraceptives Between Medications Containing 3 Mg Drospirenone/30 Microg Ethinylestradiol and 150 Microg Levonogestrel/30 Microg Ethinylestradiol in Thai Women. Contraception. 2004;69(1):23-6. PubMed PMID: 14720615.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - An open-label randomized comparative study of oral contraceptives between medications containing 3 mg drospirenone/30 microg ethinylestradiol and 150 microg levonogestrel/30 microg ethinylestradiol in Thai women. AU - Suthipongse,Wichit, AU - Taneepanichskul,Surasak, PY - 2004/1/15/pubmed PY - 2004/5/11/medline PY - 2004/1/15/entrez SP - 23 EP - 6 JF - Contraception JO - Contraception VL - 69 IS - 1 N2 - This study was conducted to compare the cycle control, efficacy and adverse events of a new low-dose oral contraceptive pill regimen containing 3 mg drospirenone (DRSP)/30 microg ethinylestradiol (EE), with a widely prescribed 150 microg levonogestrel (LNG)/30 microg EE. The results of this comparative trial demonstrated that the two preparations had no statistically significant difference in terms of cycle control, efficacy and adverse events. The occurrence of spotting and breakthrough bleeding was low and was not different between the two regimens. There was neither amenorrhea nor pregnancies reported in either group. The most common adverse events in both groups were nausea, headache and breast tenderness. Also statistically significant changes were found in body weight and blood pressure in both groups at the end of the study. In conclusion, the 3 mg DRSP/30 microg EE regimen provides good cycle control with reliable contraceptive efficacy and a low incidence of adverse events equal to the 150 microg LNG/30 microg EE preparation. Compared with the 150 microg LNG/30 microg EE preparation, the 3 mg DRSP/30 microg EE preparation demonstrated a more favorable effect on body weight and blood pressure, with the mean body weight and mean blood pressure remaining lower than baseline mean. The new formulation may be especially beneficial for women susceptible to body weight gain and rise in blood pressure. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/14720615/An_open_label_randomized_comparative_study_of_oral_contraceptives_between_medications_containing_3_mg_drospirenone/30_microg_ethinylestradiol_and_150_microg_levonogestrel/30_microg_ethinylestradiol_in_Thai_women_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010782403002300 DB - PRIME DP - Unbound Medicine ER -