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Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 microg/ ethinylestradiol 15 microg and a 21-day regimen of desogestrel 150 microg/ethinylestradiol 20 microg.
Eur J Contracept Reprod Health Care. 1999 Nov; 4 Suppl 2:17-25.EJ

Abstract

OBJECTIVE

This multicenter, open-label study was conducted to compare the cycle control, efficacy and safety of a 24-day regimen of a new ultra-low-dose oral contraceptive containing gestodene (GTD) 60 microg/ethinylestradiol (EE) 15 microg and a 21-day regimen of desogestrel (DSG) 150 microg/EE 20 microg.

METHODS

Healthy women at least 18 years of age who had had regular menstrual cycles for the prior 3 months were randomly assigned to treatment for six cycles.

RESULTS

Data from 1074 women were included in the analyses. Overall, 65% of cycles were normal with GTD/EE and 78% with DSG/EE. The overall incidence of breakthrough bleeding and/or spotting was 29% with GTD/EE and 20% with DSG/EE, with absence of bleeding occurring in 6% of cycles in the GTD/EE group and 1% of cycles in the DSG/EE group. The GTD/EE group had a significantly shorter length of bleeding episodes (4 vs. 5 days, p < 0.001), a significantly lower intensity of bleeding (p < 0.01) and a significantly shorter time for onset of withdrawal bleeding than the DSG/EE group (p < 0.001). Safety profiles for the two treatment groups were similar. Significantly more subjects in the DSG/ EE group withdrew because of breast pain (p = 0.03) and nausea or vomiting (p = 0.05). One pregnancy occurred in each treatment group.

CONCLUSIONS

The 24-day regimen of GTD 60 microg/EE 15 microg provided good efficacy, acceptable cycle control and a favorable safety profile compared with DSG/EE. This ultra-low-dose formulation offers unique advantages in efficacy and safety for oral contraception.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

14677621

Citation

"Cycle Control, Safety and Efficacy of a 24-day Regimen of Gestodene 60 Microg/ Ethinylestradiol 15 Microg and a 21-day Regimen of Desogestrel 150 Microg/ethinylestradiol 20 Microg." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 4 Suppl 2, 1999, pp. 17-25.
Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 microg/ ethinylestradiol 15 microg and a 21-day regimen of desogestrel 150 microg/ethinylestradiol 20 microg. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:17-25.
(1999). Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 microg/ ethinylestradiol 15 microg and a 21-day regimen of desogestrel 150 microg/ethinylestradiol 20 microg. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 4 Suppl 2, 17-25.
Cycle Control, Safety and Efficacy of a 24-day Regimen of Gestodene 60 Microg/ Ethinylestradiol 15 Microg and a 21-day Regimen of Desogestrel 150 Microg/ethinylestradiol 20 Microg. Eur J Contracept Reprod Health Care. 1999;4 Suppl 2:17-25. PubMed PMID: 14677621.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 microg/ ethinylestradiol 15 microg and a 21-day regimen of desogestrel 150 microg/ethinylestradiol 20 microg. PY - 2003/12/18/pubmed PY - 2004/1/22/medline PY - 2003/12/18/entrez SP - 17 EP - 25 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: This multicenter, open-label study was conducted to compare the cycle control, efficacy and safety of a 24-day regimen of a new ultra-low-dose oral contraceptive containing gestodene (GTD) 60 microg/ethinylestradiol (EE) 15 microg and a 21-day regimen of desogestrel (DSG) 150 microg/EE 20 microg. METHODS: Healthy women at least 18 years of age who had had regular menstrual cycles for the prior 3 months were randomly assigned to treatment for six cycles. RESULTS: Data from 1074 women were included in the analyses. Overall, 65% of cycles were normal with GTD/EE and 78% with DSG/EE. The overall incidence of breakthrough bleeding and/or spotting was 29% with GTD/EE and 20% with DSG/EE, with absence of bleeding occurring in 6% of cycles in the GTD/EE group and 1% of cycles in the DSG/EE group. The GTD/EE group had a significantly shorter length of bleeding episodes (4 vs. 5 days, p < 0.001), a significantly lower intensity of bleeding (p < 0.01) and a significantly shorter time for onset of withdrawal bleeding than the DSG/EE group (p < 0.001). Safety profiles for the two treatment groups were similar. Significantly more subjects in the DSG/ EE group withdrew because of breast pain (p = 0.03) and nausea or vomiting (p = 0.05). One pregnancy occurred in each treatment group. CONCLUSIONS: The 24-day regimen of GTD 60 microg/EE 15 microg provided good efficacy, acceptable cycle control and a favorable safety profile compared with DSG/EE. This ultra-low-dose formulation offers unique advantages in efficacy and safety for oral contraception. SN - 1362-5187 UR - https://www.unboundmedicine.com/medline/citation/14677621/Cycle_control_safety_and_efficacy_of_a_24_day_regimen_of_gestodene_60_microg/_ethinylestradiol_15_microg_and_a_21_day_regimen_of_desogestrel_150_microg/ethinylestradiol_20_microg_ L2 - http://www.tandfonline.com/doi/full/10.3109/13625189909085266 DB - PRIME DP - Unbound Medicine ER -