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Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study.

Abstract

This study compares the contraceptive reliability, cycle control, and tolerability of two oral contraceptive preparations containing 20 micrograms of ethinyl estradiol combined with either 75 micrograms of gestodene (EE/GSD) or 150 micrograms of desogestrel (EE/DSG). Women received the trial preparations daily for 21 days, followed by a 7-day pill-free interval. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of 12 cycles. Efficacy data of 14,700 treatment cycles (EE/GSD: 7299; EE/DSG: 7401) were obtained from 1476 women (EE/GSD, n = 740; EE/DSG, n = 736). Both preparations provided effective contraception and good cycle control with a similarly low incidence of both spotting and breakthrough bleeding. The spotting rates in both treatment groups decreased from 35.1% (EE/GSD) and 37.5% (EE/DSG) in the first treatment cycle to approximately 10% in the fourth treatment cycle. The spotting incidence as percent of the total number of cycles was 12.7% for EE/GSD and 14.3% for EE/DSG. The breakthrough bleeding incidence was 5.2% of all cycles for EE/GSD and 6.0% of all cycles for EE/DSG. For 84.7% of the cycles in the gestodene group and for 82.5% of the cycles in the desogestrel group, neither spotting nor breakthrough bleeding were recorded. Overall, the spotting and breakthrough bleeding incidence tended to be lower with EE/GSD than with EE/DSG. However, the difference was not statistically significant. Amenorrhea was recorded in 2.7% of the cycles with EE/GSD and in 2.9% with EE/DSG. Both preparations were well tolerated and showed a similar pattern of adverse events. More than 83% of the women in both groups either did not gain weight or lost more than 2 kg. Both preparations had a beneficial effect on dysmenorrhea. Both regimens provided reliable contraception and good cycle control. The incidence of adverse events was relatively low and both preparations were well tolerated.

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  • Authors+Show Affiliations

    ,

    Department for Gynecology and Obstetrics, University of Heidelberg, Germany. jan.endrikat@schering,de

    , , ,

    Source

    Contraception 60:5 1999 Nov pg 269-74

    MeSH

    Adolescent
    Adult
    Contraceptives, Oral, Combined
    Desogestrel
    Estradiol Congeners
    Ethinyl Estradiol
    Female
    Humans
    Menstrual Cycle
    Norpregnenes
    Pregnancy
    Progesterone Congeners
    Prospective Studies
    Uterine Hemorrhage

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    10717778

    Citation

    Endrikat, J, et al. "Comparison of Efficacy, Cycle Control, and Tolerability of Two Low-dose Oral Contraceptives in a Multicenter Clinical Study." Contraception, vol. 60, no. 5, 1999, pp. 269-74.
    Endrikat J, Düsterberg B, Ruebig A, et al. Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. Contraception. 1999;60(5):269-74.
    Endrikat, J., Düsterberg, B., Ruebig, A., Gerlinger, C., & Strowitzki, T. (1999). Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. Contraception, 60(5), pp. 269-74.
    Endrikat J, et al. Comparison of Efficacy, Cycle Control, and Tolerability of Two Low-dose Oral Contraceptives in a Multicenter Clinical Study. Contraception. 1999;60(5):269-74. PubMed PMID: 10717778.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. AU - Endrikat,J, AU - Düsterberg,B, AU - Ruebig,A, AU - Gerlinger,C, AU - Strowitzki,T, PY - 2000/3/16/pubmed PY - 2000/3/16/medline PY - 2000/3/16/entrez KW - Austria KW - Comparative Studies KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Effectiveness KW - Contraceptive Methods KW - Contraceptive Usage KW - Desogestrel KW - Developed Countries KW - Ethinyl Estradiol KW - Europe KW - Family Planning KW - France KW - Gestodene KW - Italy KW - Mediterranean Countries KW - Method Acceptability KW - Netherlands KW - Northern Europe KW - Oral Contraceptives KW - Research Methodology KW - Research Report KW - Southern Europe KW - Studies KW - Switzerland KW - United Kingdom KW - Western Europe SP - 269 EP - 74 JF - Contraception JO - Contraception VL - 60 IS - 5 N2 - This study compares the contraceptive reliability, cycle control, and tolerability of two oral contraceptive preparations containing 20 micrograms of ethinyl estradiol combined with either 75 micrograms of gestodene (EE/GSD) or 150 micrograms of desogestrel (EE/DSG). Women received the trial preparations daily for 21 days, followed by a 7-day pill-free interval. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of 12 cycles. Efficacy data of 14,700 treatment cycles (EE/GSD: 7299; EE/DSG: 7401) were obtained from 1476 women (EE/GSD, n = 740; EE/DSG, n = 736). Both preparations provided effective contraception and good cycle control with a similarly low incidence of both spotting and breakthrough bleeding. The spotting rates in both treatment groups decreased from 35.1% (EE/GSD) and 37.5% (EE/DSG) in the first treatment cycle to approximately 10% in the fourth treatment cycle. The spotting incidence as percent of the total number of cycles was 12.7% for EE/GSD and 14.3% for EE/DSG. The breakthrough bleeding incidence was 5.2% of all cycles for EE/GSD and 6.0% of all cycles for EE/DSG. For 84.7% of the cycles in the gestodene group and for 82.5% of the cycles in the desogestrel group, neither spotting nor breakthrough bleeding were recorded. Overall, the spotting and breakthrough bleeding incidence tended to be lower with EE/GSD than with EE/DSG. However, the difference was not statistically significant. Amenorrhea was recorded in 2.7% of the cycles with EE/GSD and in 2.9% with EE/DSG. Both preparations were well tolerated and showed a similar pattern of adverse events. More than 83% of the women in both groups either did not gain weight or lost more than 2 kg. Both preparations had a beneficial effect on dysmenorrhea. Both regimens provided reliable contraception and good cycle control. The incidence of adverse events was relatively low and both preparations were well tolerated. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/10717778/Comparison_of_efficacy_cycle_control_and_tolerability_of_two_low_dose_oral_contraceptives_in_a_multicenter_clinical_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(99)00097-9 DB - PRIME DP - Unbound Medicine ER -