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A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance.

Abstract

The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation.

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  • Authors+Show Affiliations

    ,

    Schering AG, Berlin, Germany.

    , , , ,

    Source

    Contraception 52:4 1995 Oct pg 229-35

    MeSH

    Adolescent
    Adult
    Amenorrhea
    Austria
    Body Weight
    Contraceptives, Oral
    Desogestrel
    Dose-Response Relationship, Drug
    Drug Combinations
    Drug Tolerance
    Dysmenorrhea
    Ethinyl Estradiol
    Female
    France
    Headache
    Humans
    Longitudinal Studies
    Menstrual Cycle
    Nausea
    Norpregnenes
    Progesterone Congeners
    Time Factors

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Controlled Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    8605781

    Citation

    Endrikat, J, et al. "A Twelve-month Comparative Clinical Investigation of Two Low-dose Oral Contraceptives Containing 20 Micrograms Ethinylestradiol/75 Micrograms Gestodene and 20 Micrograms Ethinylestradiol/150 Micrograms Desogestrel, With Respect to Efficacy, Cycle Control and Tolerance." Contraception, vol. 52, no. 4, 1995, pp. 229-35.
    Endrikat J, Jaques MA, Mayerhofer M, et al. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance. Contraception. 1995;52(4):229-35.
    Endrikat, J., Jaques, M. A., Mayerhofer, M., Pelissier, C., Müller, U., & Düsterberg, B. (1995). A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance. Contraception, 52(4), pp. 229-35.
    Endrikat J, et al. A Twelve-month Comparative Clinical Investigation of Two Low-dose Oral Contraceptives Containing 20 Micrograms Ethinylestradiol/75 Micrograms Gestodene and 20 Micrograms Ethinylestradiol/150 Micrograms Desogestrel, With Respect to Efficacy, Cycle Control and Tolerance. Contraception. 1995;52(4):229-35. PubMed PMID: 8605781.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance. AU - Endrikat,J, AU - Jaques,M A, AU - Mayerhofer,M, AU - Pelissier,C, AU - Müller,U, AU - Düsterberg,B, PY - 1995/10/1/pubmed PY - 1995/10/1/medline PY - 1995/10/1/entrez SP - 229 EP - 35 JF - Contraception JO - Contraception VL - 52 IS - 4 N2 - The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/8605781/A_twelve_month_comparative_clinical_investigation_of_two_low_dose_oral_contraceptives_containing_20_micrograms_ethinylestradiol/75_micrograms_gestodene_and_20_micrograms_ethinylestradiol/150_micrograms_desogestrel_with_respect_to_efficacy_cycle_control_and_tolerance_ L2 - https://linkinghub.elsevier.com/retrieve/pii/001078249500191C DB - PRIME DP - Unbound Medicine ER -