A multicenter, randomized study of an extended cycle oral contraceptive

F. D. Anderson; Howard Hait; Davis Baldwin; Irwin Kerber; Alfred Moffet; James A. Simon; Karen Kreutner; John Angelo; Suzanne Barbier; Paul Blumenthal; Anthony Chavez; Nancy Cooley; Jay Cooper; Vivien D'Andrea; Thomas Davies; Kyrin Dunston; Edward Durbin; Donald Edger; Robert Feldman; Frederick Fingerhut; Frances Fisk; Samuel Flannagan; Bill Griffin; Charles Herring; Andrew Kaunitz; Rebecca Knight; James Lackey; Sooji Lee-Rugh; Thomas Littlejohn; James Maly; Phyllis Marx; Marjorie Merod; David Morin; Robert Mucciola; Anjuli Nayak; Robert Nett; Arthur Pitterman; Robert Prout; David Portman; Paul Miller; George Raad; Sidney Rosenblatt; Mark Shepard; John Stoukides; Michael Swor; Timothy Truitt; Wulf Utian; Cheryl Walker

doi:10.1016/S0010-7824(03)00141-0

A multicenter, randomized study of an extended cycle oral contraceptive

F. D. Anderson, Howard Hait, Davis Baldwin, Irwin Kerber, Alfred Moffet, James A. Simon, Karen Kreutner, John Angelo, Suzanne Barbier, Paul Blumenthal, Anthony Chavez, Nancy Cooley, Jay Cooper, Vivien D'Andrea, Thomas Davies, Kyrin Dunston, Edward Durbin, Donald Edger, Robert Feldman, Frederick FingerhutFrances Fisk, Samuel Flannagan, Bill Griffin, Charles Herring, Andrew Kaunitz, Rebecca Knight, James Lackey, Sooji Lee-Rugh, Thomas Littlejohn, James Maly, Phyllis Marx, Marjorie Merod, David Morin, Robert Mucciola, Anjuli Nayak, Robert Nett, Arthur Pitterman, Robert Prout, David Portman, Paul Miller, George Raad, Sidney Rosenblatt, Mark Shepard, John Stoukides, Michael Swor, Timothy Truitt, Wulf Utian, Cheryl Walker

Research output: Contribution to journal › Article › peer-review

258 Scopus citations

Abstract

Objective: To assess the efficacy and safety of Seasonale®, 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle. Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 μg EE/150 μg LNG followed by 7 days of placebo, was effective, safe and well tolerated.

Original language	English (US)
Pages (from-to)	89-96
Number of pages	8
Journal	Contraception
Volume	68
Issue number	2
DOIs	https://doi.org/10.1016/S0010-7824(03)00141-0
State	Published - Aug 1 2003

Keywords

Cycle control
Electronic diary
Extended cycle
Oral contraceptive
Seasonale

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/S0010-7824(03)00141-0

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Anderson, F. D., Hait, H., Baldwin, D., Kerber, I., Moffet, A., Simon, J. A., Kreutner, K., Angelo, J., Barbier, S., Blumenthal, P., Chavez, A., Cooley, N., Cooper, J., D'Andrea, V., Davies, T., Dunston, K., Durbin, E., Edger, D., Feldman, R., ... Walker, C. (2003). A multicenter, randomized study of an extended cycle oral contraceptive. Contraception, 68(2), 89-96. https://doi.org/10.1016/S0010-7824(03)00141-0

Anderson, FD, Hait, H, Baldwin, D, Kerber, I, Moffet, A, Simon, JA, Kreutner, K, Angelo, J, Barbier, S, Blumenthal, P, Chavez, A, Cooley, N, Cooper, J, D'Andrea, V, Davies, T, Dunston, K, Durbin, E, Edger, D, Feldman, R, Fingerhut, F, Fisk, F, Flannagan, S, Griffin, B, Herring, C, Kaunitz, A, Knight, R, Lackey, J, Lee-Rugh, S, Littlejohn, T, Maly, J, Marx, P, Merod, M, Morin, D, Mucciola, R, Nayak, A, Nett, R, Pitterman, A, Prout, R, Portman, D, Miller, P, Raad, G, Rosenblatt, S, Shepard, M, Stoukides, J, Swor, M, Truitt, T, Utian, W & Walker, C 2003, 'A multicenter, randomized study of an extended cycle oral contraceptive', Contraception, vol. 68, no. 2, pp. 89-96. https://doi.org/10.1016/S0010-7824(03)00141-0

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title = "A multicenter, randomized study of an extended cycle oral contraceptive",

abstract = "Objective: To assess the efficacy and safety of Seasonale{\textregistered}, 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle. Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 μg EE/150 μg LNG followed by 7 days of placebo, was effective, safe and well tolerated.",

keywords = "Cycle control, Electronic diary, Extended cycle, Oral contraceptive, Seasonale",

author = "Anderson, {F. D.} and Howard Hait and Davis Baldwin and Irwin Kerber and Alfred Moffet and Simon, {James A.} and Karen Kreutner and John Angelo and Suzanne Barbier and Paul Blumenthal and Anthony Chavez and Nancy Cooley and Jay Cooper and Vivien D'Andrea and Thomas Davies and Kyrin Dunston and Edward Durbin and Donald Edger and Robert Feldman and Frederick Fingerhut and Frances Fisk and Samuel Flannagan and Bill Griffin and Charles Herring and Andrew Kaunitz and Rebecca Knight and James Lackey and Sooji Lee-Rugh and Thomas Littlejohn and James Maly and Phyllis Marx and Marjorie Merod and David Morin and Robert Mucciola and Anjuli Nayak and Robert Nett and Arthur Pitterman and Robert Prout and David Portman and Paul Miller and George Raad and Sidney Rosenblatt and Mark Shepard and John Stoukides and Michael Swor and Timothy Truitt and Wulf Utian and Cheryl Walker",

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T1 - A multicenter, randomized study of an extended cycle oral contraceptive

AU - Anderson, F. D.

AU - Hait, Howard

AU - Baldwin, Davis

AU - Kerber, Irwin

AU - Moffet, Alfred

AU - Simon, James A.

AU - Kreutner, Karen

AU - Angelo, John

AU - Barbier, Suzanne

AU - Blumenthal, Paul

AU - Chavez, Anthony

AU - Cooley, Nancy

AU - Cooper, Jay

AU - D'Andrea, Vivien

AU - Davies, Thomas

AU - Dunston, Kyrin

AU - Durbin, Edward

AU - Edger, Donald

AU - Feldman, Robert

AU - Fingerhut, Frederick

AU - Fisk, Frances

AU - Flannagan, Samuel

AU - Griffin, Bill

AU - Herring, Charles

AU - Kaunitz, Andrew

AU - Knight, Rebecca

AU - Lackey, James

AU - Lee-Rugh, Sooji

AU - Littlejohn, Thomas

AU - Maly, James

AU - Marx, Phyllis

AU - Merod, Marjorie

AU - Morin, David

AU - Mucciola, Robert

AU - Nayak, Anjuli

AU - Nett, Robert

AU - Pitterman, Arthur

AU - Prout, Robert

AU - Portman, David

AU - Miller, Paul

AU - Raad, George

AU - Rosenblatt, Sidney

AU - Shepard, Mark

AU - Stoukides, John

AU - Swor, Michael

AU - Truitt, Timothy

AU - Utian, Wulf

AU - Walker, Cheryl

PY - 2003/8/1

Y1 - 2003/8/1

N2 - Objective: To assess the efficacy and safety of Seasonale®, 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle. Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 μg EE/150 μg LNG followed by 7 days of placebo, was effective, safe and well tolerated.

AB - Objective: To assess the efficacy and safety of Seasonale®, 91-day extended cycle oral contraceptive (OC). Methods: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG), and Nordette-28 (30 μg EE/150 μg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. Results: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OC regimen by the fourth extended cycle. Conclusion: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 μg EE/150 μg LNG followed by 7 days of placebo, was effective, safe and well tolerated.

KW - Cycle control

KW - Electronic diary

KW - Extended cycle

KW - Oral contraceptive

KW - Seasonale

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A multicenter, randomized study of an extended cycle oral contraceptive

Abstract

Keywords

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