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The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg.
Eur J Contracept Reprod Health Care. 1999 Nov; 4 Suppl 2:9-15.EJ

Abstract

OBJECTIVE

The safety and contraceptive efficacy of a new 24-day regimen of an oral contraceptive combination containing gestodene (GTD) 60 microg and ethinylestradiol (EE) 15 microg was evaluated in an open-label, multicenter study.

METHODS

Adult women received GTD 60 microg/EE 15 microg from day 1 to 24 and 4 days of placebo during a 28-day cycle for either 13 or 19 cycles.

RESULTS

Of the 1515 subjects enrolled, 1496 were included in the intent-to-treat analysis. A total of three pregnancies were reported during the 18 194 treatment cycles of the study, yielding a Pearl index of 0.21. Life-table analysis, based on 16 954 cycles, gave an accidental pregnancy rate of 0.0033. The most frequent adverse events were headache (reported in 35% of subjects), absence of bleeding (16%), flu-like syndrome (15%), pharyngitis (15%) and abdominal pain (15%). The most frequent reasons for withdrawal from the study were metrorrhagia, flu syndrome and absence of bleeding. Analyses of withdrawal and intermenstrual bleeding and spotting indicated acceptable cycle control.

CONCLUSIONS

The 24-day GTD 60 microg/EE 15 microg regimen appears to be a well-tolerated and effective method for low-dose oral contraception. The current formulation offers an ultra-low steroidal dosage combined with a reduced pill-free interval to improve contraceptive efficacy.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

14677620

Citation

"The Safety and Contraceptive Efficacy of a 24-day Low-dose Oral Contraceptive Regimen Containing Gestodene 60 Microg and Ethinylestradiol 15 Microg." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 4 Suppl 2, 1999, pp. 9-15.
The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:9-15.
(1999). The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 4 Suppl 2, 9-15.
The Safety and Contraceptive Efficacy of a 24-day Low-dose Oral Contraceptive Regimen Containing Gestodene 60 Microg and Ethinylestradiol 15 Microg. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:9-15. PubMed PMID: 14677620.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 microg and ethinylestradiol 15 microg. PY - 2003/12/18/pubmed PY - 2004/1/22/medline PY - 2003/12/18/entrez SP - 9 EP - 15 JF - The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception JO - Eur J Contracept Reprod Health Care VL - 4 Suppl 2 N2 - OBJECTIVE: The safety and contraceptive efficacy of a new 24-day regimen of an oral contraceptive combination containing gestodene (GTD) 60 microg and ethinylestradiol (EE) 15 microg was evaluated in an open-label, multicenter study. METHODS: Adult women received GTD 60 microg/EE 15 microg from day 1 to 24 and 4 days of placebo during a 28-day cycle for either 13 or 19 cycles. RESULTS: Of the 1515 subjects enrolled, 1496 were included in the intent-to-treat analysis. A total of three pregnancies were reported during the 18 194 treatment cycles of the study, yielding a Pearl index of 0.21. Life-table analysis, based on 16 954 cycles, gave an accidental pregnancy rate of 0.0033. The most frequent adverse events were headache (reported in 35% of subjects), absence of bleeding (16%), flu-like syndrome (15%), pharyngitis (15%) and abdominal pain (15%). The most frequent reasons for withdrawal from the study were metrorrhagia, flu syndrome and absence of bleeding. Analyses of withdrawal and intermenstrual bleeding and spotting indicated acceptable cycle control. CONCLUSIONS: The 24-day GTD 60 microg/EE 15 microg regimen appears to be a well-tolerated and effective method for low-dose oral contraception. The current formulation offers an ultra-low steroidal dosage combined with a reduced pill-free interval to improve contraceptive efficacy. SN - 1362-5187 UR - https://www.unboundmedicine.com/medline/citation/14677620/The_safety_and_contraceptive_efficacy_of_a_24_day_low_dose_oral_contraceptive_regimen_containing_gestodene_60_microg_and_ethinylestradiol_15_microg_ L2 - http://www.tandfonline.com/doi/full/10.3109/13625189909085265 DB - PRIME DP - Unbound Medicine ER -