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A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles.
Contraception. 1997 Nov; 56(5):285-90.C

Abstract

The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

9437556

Citation

Bannemerschult, R, et al. "A Multicenter, Uncontrolled Clinical Investigation of the Contraceptive Efficacy, Cycle Control, and Safety of a New Low Dose Oral Contraceptive Containing 20 Micrograms Ethinyl Estradiol and 100 Micrograms Levonorgestrel Over Six Treatment Cycles." Contraception, vol. 56, no. 5, 1997, pp. 285-90.
Bannemerschult R, Hanker JP, Wünsch C, et al. A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. Contraception. 1997;56(5):285-90.
Bannemerschult, R., Hanker, J. P., Wünsch, C., Fox, P., Albring, M., & Brill, K. (1997). A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. Contraception, 56(5), 285-90.
Bannemerschult R, et al. A Multicenter, Uncontrolled Clinical Investigation of the Contraceptive Efficacy, Cycle Control, and Safety of a New Low Dose Oral Contraceptive Containing 20 Micrograms Ethinyl Estradiol and 100 Micrograms Levonorgestrel Over Six Treatment Cycles. Contraception. 1997;56(5):285-90. PubMed PMID: 9437556.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. AU - Bannemerschult,R, AU - Hanker,J P, AU - Wünsch,C, AU - Fox,P, AU - Albring,M, AU - Brill,K, PY - 1998/1/23/pubmed PY - 1998/1/23/medline PY - 1998/1/23/entrez KW - Clinical Research KW - Contraception KW - Contraceptive Agents, Estrogen--pharmacodynamics KW - Contraceptive Agents, Female--pharmacodynamics KW - Contraceptive Agents, Progestin--pharmacodynamics KW - Contraceptive Agents--pharmacodynamics KW - Contraceptive Effectiveness KW - Contraceptive Methods--side effects KW - Developed Countries KW - Diseases KW - Ethinyl Estradiol--pharmacodynamics KW - Europe KW - Family Planning KW - Germany KW - Levonorgestrel--pharmacodynamics KW - Menstrual Cycle KW - Menstruation KW - Menstruation Disorders KW - Oral Contraceptives, Low-dose--side effects KW - Oral Contraceptives--side effects KW - Reproduction KW - Research Methodology KW - Research Report KW - Western Europe SP - 285 EP - 90 JF - Contraception JO - Contraception VL - 56 IS - 5 N2 - The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events. SN - 0010-7824 UR - https://www.unboundmedicine.com/medline/citation/9437556/A_multicenter_uncontrolled_clinical_investigation_of_the_contraceptive_efficacy_cycle_control_and_safety_of_a_new_low_dose_oral_contraceptive_containing_20_micrograms_ethinyl_estradiol_and_100_micrograms_levonorgestrel_over_six_treatment_cycles_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010782497001571 DB - PRIME DP - Unbound Medicine ER -