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A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance.
Contraception. 1997 Mar; 55(3):131-7.C

Abstract

The aim of this study was to compare contraceptive reliability, cycle control, and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol (EE2) and 75 micrograms gestodene (GSD), with a reference preparation containing a similar dose of gestodene but in combination with 30 micrograms ethinylestradiol. A higher incidence of intermenstrual bleeding was apparent under the 20 micrograms EE2 oral contraceptive. For the 20 micrograms EE2 preparation, 47.4% of all women reported spotting at least once over a period of 12 treatment cycles, whereas this figure was 35.5% for the 30 micrograms EE2 pill (p < 0.05). However, the incidence was within a range that corresponds to that of other OCs. The cumulative breakthrough bleeding rates (at least once during the one year of treatment) of 14.5% (20 micrograms EE2) and 11.8% (30 micrograms EE2) of women were not significantly different. In relation to all cycles, the intermenstrual bleeding rates were remarkably lower, indicating that the majority of the volunteers experienced such events only in few cycles under treatment: the spotting rate was 11.5% (20 micrograms EE2) and 7.2% (30 micrograms EE2) of all cycles, and the breakthrough bleeding rate was 2.6% and 1.6% of all cycles, respectively. Three pregnancies were recorded during the study (one in the 20 micrograms EE2 + 75 micrograms GSD group, two in the 30 micrograms EE2 + 75 micrograms GSD group). All three could be explained either by intake irregularities or by circumstances impairing the contraceptive effect. The influence of both treatments on the blood pressure and body weight proved to be extremely slight. Adverse events in both groups were rare and differences in the frequency of adverse events were not apparent. The discontinuation rate due to adverse events, including intermenstrual bleeding, was low (9.8% for 20 micrograms EE2 + 75 micrograms GSD, and 7.2% for 30 micrograms EE2 + 75 micrograms GSD) and was in the lower range known for other oral contraceptives. Both preparations were well accepted by the volunteers. The data obtained demonstrate clinically acceptable cycle control, good tolerance, and a high standard of contraceptive reliability for both drugs. Prescription of the 20 micrograms EE2 preparation could be the first-line therapy in order to provide the lowest amount of EE2 possible. In case of persistent cycle control problems, a switch to the 30 micrograms EE2 drug should be considered.

Authors+Show Affiliations

Schering AG, Berlin, Germany.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9115000

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 30 Micrograms Ethinylestradiol/75 Micrograms Gestodene, With Respect to Efficacy, Cycle Control, and Tolerance." Contraception, vol. 55, no. 3, 1997, pp. 131-7.
Endrikat J, Müller U, Düsterberg B. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance. Contraception. 1997;55(3):131-7.
Endrikat, J., Müller, U., & Düsterberg, B. (1997). A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance. Contraception, 55(3), 131-7.
Endrikat J, Müller U, Düsterberg B. A Twelve-month Comparative Clinical Investigation of Two Low-dose Oral Contraceptives Containing 20 Micrograms Ethinylestradiol/75 Micrograms Gestodene and 30 Micrograms Ethinylestradiol/75 Micrograms Gestodene, With Respect to Efficacy, Cycle Control, and Tolerance. Contraception. 1997;55(3):131-7. PubMed PMID: 9115000.
* 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 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance. AU - Endrikat,J, AU - Müller,U, AU - Düsterberg,B, PY - 1997/3/1/pubmed PY - 1997/3/1/medline PY - 1997/3/1/entrez KW - Clinical Research KW - Contraception KW - Contraceptive Agents, Estrogen--administraction and dosage KW - Contraceptive Agents, Female--administraction and dosage KW - Contraceptive Agents, Progestin KW - Contraceptive Agents--administraction and dosage KW - Contraceptive Effectiveness KW - Contraceptive Methods KW - Contraceptive Usage KW - Developed Countries KW - Diseases KW - Ethinyl Estradiol--administraction and dosage KW - Europe KW - Family Planning KW - Germany KW - Gestodene KW - Menstruation Disorders KW - Method Acceptability KW - Oral Contraceptives KW - Oral Contraceptives, Low-dose KW - Research Methodology KW - Western Europe SP - 131 EP - 7 JF - Contraception JO - Contraception VL - 55 IS - 3 N2 - The aim of this study was to compare contraceptive reliability, cycle control, and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol (EE2) and 75 micrograms gestodene (GSD), with a reference preparation containing a similar dose of gestodene but in combination with 30 micrograms ethinylestradiol. A higher incidence of intermenstrual bleeding was apparent under the 20 micrograms EE2 oral contraceptive. For the 20 micrograms EE2 preparation, 47.4% of all women reported spotting at least once over a period of 12 treatment cycles, whereas this figure was 35.5% for the 30 micrograms EE2 pill (p < 0.05). However, the incidence was within a range that corresponds to that of other OCs. The cumulative breakthrough bleeding rates (at least once during the one year of treatment) of 14.5% (20 micrograms EE2) and 11.8% (30 micrograms EE2) of women were not significantly different. In relation to all cycles, the intermenstrual bleeding rates were remarkably lower, indicating that the majority of the volunteers experienced such events only in few cycles under treatment: the spotting rate was 11.5% (20 micrograms EE2) and 7.2% (30 micrograms EE2) of all cycles, and the breakthrough bleeding rate was 2.6% and 1.6% of all cycles, respectively. Three pregnancies were recorded during the study (one in the 20 micrograms EE2 + 75 micrograms GSD group, two in the 30 micrograms EE2 + 75 micrograms GSD group). All three could be explained either by intake irregularities or by circumstances impairing the contraceptive effect. The influence of both treatments on the blood pressure and body weight proved to be extremely slight. Adverse events in both groups were rare and differences in the frequency of adverse events were not apparent. The discontinuation rate due to adverse events, including intermenstrual bleeding, was low (9.8% for 20 micrograms EE2 + 75 micrograms GSD, and 7.2% for 30 micrograms EE2 + 75 micrograms GSD) and was in the lower range known for other oral contraceptives. Both preparations were well accepted by the volunteers. The data obtained demonstrate clinically acceptable cycle control, good tolerance, and a high standard of contraceptive reliability for both drugs. Prescription of the 20 micrograms EE2 preparation could be the first-line therapy in order to provide the lowest amount of EE2 possible. In case of persistent cycle control problems, a switch to the 30 micrograms EE2 drug should be considered. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/9115000/A_twelve_month_comparative_clinical_investigation_of_two_low_dose_oral_contraceptives_containing_20_micrograms_ethinylestradiol/75_micrograms_gestodene_and_30_micrograms_ethinylestradiol/75_micrograms_gestodene_with_respect_to_efficacy_cycle_control_and_tolerance_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010782497000255 DB - PRIME DP - Unbound Medicine ER -