The safety and contraceptive efficacy of a 24-day low-dose oral contraceptive regimen containing gestodene 60 μg and ethinylestradiol 15 μg

被引：0

作者：

Bocci, A. ^{[1
]}

Spielniann, D. ^{[1
]}

Azzini, Pr ^{[1
]}

Guaschino, Pr ^{[1
]}

Affronti, G. ^{[1
]}

Villani, Pr ^{[1
]}

Boselli, Pr ^{[1
]}

Genazzani, Pr ^{[1
]}

Flamigni, Z. C. ^{[1
]}

Omodei, U. ^{[1
]}

Bolis, P. ^{[1
]}

Marsoni, V. ^{[1
]}

Luerti, M. ^{[1
]}

Simenel, J. L. ^{[1
]}

Ouvry-Neveu, B. ^{[1
]}

Andre, G. ^{[1
]}

David, S. ^{[1
]}

Durand, J. L. ^{[1
]}

Ehret-Mentre, C. ^{[1
]}

Gensburger, J. M. ^{[1
]}

Goetzmann, P. ^{[1
]}

Jung-Faerber, S. ^{[1
]}

Keller, D. ^{[1
]}

Lempereur, M. ^{[1
]}

Plumere, C. ^{[1
]}

Spielmann, A. ^{[1
]}

Katz, J. L. ^{[1
]}

Sebaoun, J. ^{[1
]}

Belaisch, J. ^{[1
]}

Hammer, F. ^{[1
]}

Salama, B. ^{[1
]}

Aissaoui, S. ^{[1
]}

Taube, A. M. ^{[1
]}

Nakache, H. ^{[1
]}

Soria, J. ^{[1
]}

Joffo, M. ^{[1
]}

Lardenois, H. ^{[1
]}

Leclerc, P. ^{[1
]}

Ponsar, C. ^{[1
]}

Saubry-Bobet, V. ^{[1
]}

Blaiset, E. ^{[1
]}

Veyres, F. ^{[1
]}

Clamp, M. ^{[1
]}

Menon, K. V. K. ^{[1
]}

Moran, D. G. ^{[1
]}

Randall, S. ^{[1
]}

Shaw, P. J. ^{[1
]}

Bruni, V. ^{[1
]}

Massobrio, M. ^{[1
]}

Crosignani, P. ^{[1
]}

机构：

[1] Wyeth Ayersr Res, F-92031 Paris, France

来源：

EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE | 1999年 / 4卷

关键词：

Oral contraceptive; Contraceptive efficacy; Gestodene; Ethinylestradiol;

D O I：

暂无

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Objective The safety and contraceptive efficacy of a new 24-day regimen of an oral contraceptive combination containing gestodene (GTD) 60 mu g and ethinylestradiol (EE) 15 mu g was evaluated in an open-label, multicenter study. Methods Adult women received GTD 60 mu g/EE 15 mu g 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 mu g/EE 15 mu g, 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.

引用

页码：9 / 15

页数：7

共 50 条

[1] Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 μg ethinylestradiol and 3 mg drospirenone
Bachmann, G
Sulak, PJ
Sampson-Landers, C
Benda, N
Marr, J
CONTRACEPTION, 2004, 70 (03) : 191 - 198
[2] Sexual behavior of women taking low-dose oral contraceptive containing 15 μg ethinylestradiol/60 μg gestodene
Caruso, S
Agnello, C
Intelisano, G
Farina, M
Di Mari, L
Cianci, A
CONTRACEPTION, 2004, 69 (03) : 237 - 240
[3] Cycle control, safety and efficacy of a 24-day regimen of gestodene 60 μg/ethinylestradiol 15 μg and a 21-day regimen of desogestrel 150 μg/ethinylestradiol 20 μg
Affronti, G.
Spiclinann, D.
Ambrosini, A.
Bocci, A.
Campogrande, M.
Dodero, D.
Flamigni, C.
Giardina, G.
Litta, P.
Massobrio, M.
Scarselli, G.
Meriggi, E.
Pauwels, C. P.
DeBruyn, M.
Gerris, J.
Nolens, J. P.
Blanchere, J. P.
Bernard-Besnoit, A.
Bilhaut, J. P.
Coudray, J.
Guigues, B.
Jolly, C.
Maupain, M.
Hieu, N. Nguyen
Amadio, E.
Dalbos, D.
De Granvilliers, M. A.
Devaure, Y.
De Vedrine, C. H.
Dress, M. M.
Guibert, L.
Hazane, J. C.
Kern, A. M.
Levrier, M.
Malgouyat, J.
Mallet, F.
Marteau, C.
Safayan, A.
Sentenac, J.
De Boer, R.
Van Enk, A.
Mattheussens, O. J. A.
The, H. S.
Ypma, T. J. D.
Rickli, J. P.
Florek, E.
Stadlin, M.
Bitzer, J.
Brunclik, V.
Grueter, J.
EUROPEAN JOURNAL OF CONTRACEPTION AND REPRODUCTIVE HEALTH CARE, 1999, 4 : 17 - 25
[4] Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 μg) and ethinyl estradiol (15 μg) on ovarian activity
Sullivan, H
Furniss, H
Spona, J
Elstein, M
FERTILITY AND STERILITY, 1999, 72 (01) : 115 - 120
[5] A review of cycle control with a low-dose oral contraceptive containing 75 μg gestodene and 20 μg ethinylestradiol
Gast, MJ
Grubb, G
GYNECOLOGICAL ENDOCRINOLOGY, 1998, 12 : 31 - 37
[6] An investigation of ovulation inhibition with a low-dose combined oral contraceptive containing 75 μg gestodene and 20 μg ethinylestradiol
Archer, DF
Gast, MJ
GYNECOLOGICAL ENDOCRINOLOGY, 1998, 12 : 7 - 12
[7] A 12-month clinical investigation with a 24-day regimen containing 15 μg ethinylestradiol plus 60 μg gestodene with respect to hemostasis and cycle control
Fruzzetti, F
Genazzani, AR
Ricci, C
De Negri, F
Bersi, C
Carmassi, F
CONTRACEPTION, 2001, 63 (06) : 303 - 307
[8] Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen
Laszlo Hernadi
Marr, Joachim
Trummer, Dietmar
De Leo, Vincenzo
Petraglia, Felice
CONTRACEPTION, 2009, 80 (01) : 18 - 24
[9] Efficacy and safety of a low-dose 21-day combined oral contraceptive containing ethinylestradiol 20μg and drospirenone 3mg
Cibula, D
Karck, U
Weidenhammer, HG
Kunz, J
Alincic, S
Marr, J
CLINICAL DRUG INVESTIGATION, 2006, 26 (03) : 143 - 150
[10] Efficacy and Safety of a Low-Dose 21-Day Combined Oral Contraceptive Containing Ethinylestradiol 20μg and Drospirenone 3mg
D. Cibula
U. Karck
H. G. Weidenhammer
J. Kunz
S. Alincic
J. Marr
Clinical Drug Investigation, 2006, 26 : 143 - 150

← 1 2 3 4 5 →