Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results

David F. Archer; Jeffrey T. Jensen; Julia V. Johnson; Hannah Borisute; Gary S. Grubb; Ginger D. Constantine

doi:10.1016/j.contraception.2006.07.005

Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results

David F. Archer, Jeffrey T. Jensen, Julia V. Johnson, Hannah Borisute, Gary S. Grubb, Ginger D. Constantine

Obstetrics and Gynecology

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

126 Scopus citations

Abstract

Objective: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg (continuous LNG/EE). Methods: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 μg/EE 20 μg daily for 12 months. Results: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. Conclusions: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

Original language	English (US)
Pages (from-to)	439-445
Number of pages	7
Journal	Contraception
Volume	74
Issue number	6
DOIs	https://doi.org/10.1016/j.contraception.2006.07.005
State	Published - Dec 2006

Keywords

Amenorrhea
Continuous oral contraceptive
Levonorgestrel/ethinyl estradiol
Menses inhibition

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/j.contraception.2006.07.005

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@article{2808e55260784870aae477ce3da8410a,

title = "Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results",

abstract = "Objective: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg (continuous LNG/EE). Methods: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 μg/EE 20 μg daily for 12 months. Results: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. Conclusions: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.",

keywords = "Amenorrhea, Continuous oral contraceptive, Levonorgestrel/ethinyl estradiol, Menses inhibition",

author = "Archer, {David F.} and Jensen, {Jeffrey T.} and Johnson, {Julia V.} and Hannah Borisute and Grubb, {Gary S.} and Constantine, {Ginger D.}",

note = "Funding Information: This study ( ClinicalTrials.gov ; NCT00245921) was supported by a grant from Wyeth Research (Collegeville, PA). Drs. David F. Archer, Jeffrey T. Jensen and Julia V. Johnson were investigators for this study and received research funding from Wyeth Research. Other sources of research funding and/or financial relationships include the following: Agile Therapeutics, Berlex, Genentech, Warner Chilcott, Lilly, Novo Nordisk, Ortho-McNeil, Organon International, Solvay Pharmaceuticals, Barr Laboratories, Duramed Pharmaceuticals, Johnson & Johnson and Wyeth for Dr. Archer; Berlex, Warner Chilcott, Pfizer, Organon International and Barr Laboratories for Dr. Jensen; and Berlex, Novo Nordisk, Pharmacia, Procter & Gamble for Dr. Johnson. Drs. Hannah Borisute, Gary S. Grubb and Ginger D. Constantine are employees of Wyeth Research. Other financial affiliations are Merck, Teva and Johnson & Johnson for Dr. Borisute; and Johnson & Johnson for Dr. Grubb. Dr. Constantine has no financial affiliations. ",

year = "2006",

month = dec,

doi = "10.1016/j.contraception.2006.07.005",

language = "English (US)",

volume = "74",

pages = "439--445",

journal = "Contraception",

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T1 - Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol

T2 - phase 3 study results

AU - Archer, David F.

AU - Jensen, Jeffrey T.

AU - Johnson, Julia V.

AU - Borisute, Hannah

AU - Grubb, Gary S.

AU - Constantine, Ginger D.

N1 - Funding Information: This study ( ClinicalTrials.gov ; NCT00245921) was supported by a grant from Wyeth Research (Collegeville, PA). Drs. David F. Archer, Jeffrey T. Jensen and Julia V. Johnson were investigators for this study and received research funding from Wyeth Research. Other sources of research funding and/or financial relationships include the following: Agile Therapeutics, Berlex, Genentech, Warner Chilcott, Lilly, Novo Nordisk, Ortho-McNeil, Organon International, Solvay Pharmaceuticals, Barr Laboratories, Duramed Pharmaceuticals, Johnson & Johnson and Wyeth for Dr. Archer; Berlex, Warner Chilcott, Pfizer, Organon International and Barr Laboratories for Dr. Jensen; and Berlex, Novo Nordisk, Pharmacia, Procter & Gamble for Dr. Johnson. Drs. Hannah Borisute, Gary S. Grubb and Ginger D. Constantine are employees of Wyeth Research. Other financial affiliations are Merck, Teva and Johnson & Johnson for Dr. Borisute; and Johnson & Johnson for Dr. Grubb. Dr. Constantine has no financial affiliations.

PY - 2006/12

Y1 - 2006/12

N2 - Objective: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg (continuous LNG/EE). Methods: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 μg/EE 20 μg daily for 12 months. Results: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. Conclusions: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

AB - Objective: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 μg/ethinyl estradiol (EE) 20 μg (continuous LNG/EE). Methods: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 μg/EE 20 μg daily for 12 months. Results: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. Conclusions: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

KW - Amenorrhea

KW - Continuous oral contraceptive

KW - Levonorgestrel/ethinyl estradiol

KW - Menses inhibition

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JO - Contraception

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Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results

Abstract

Keywords

ASJC Scopus subject areas

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