Ortho Evra ™/Evra ™ versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error

To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors. Randomized, open-label. Twelve centers. One hundred twenty-four ovulatory women. Subjects received either the patch (groups 1 and 2)...

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Published inFertility and sterility Vol. 80; no. 1; pp. 34 - 42
Main Authors Pierson, Roger A, Archer, David F, Moreau, Michèle, Shangold, Gary A, Fisher, Alan C, Creasy, George W
Format Journal Article
LanguageEnglish
Published New York, NY Elsevier Inc 01.07.2003
Elsevier Science
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Abstract To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors. Randomized, open-label. Twelve centers. One hundred twenty-four ovulatory women. Subjects received either the patch (groups 1 and 2) or one of three OCs. Correct dosing occurred in cycles 1, 2, 3, and 5. The following dosing errors were planned during cycle 4, a shortened 10-day cycle: [1] patch group 1 subjects wore one patch for 10 consecutive days; [2] for patch group 2 and OC subjects, 7 dosing days were followed by 3 drug-free days. Follicular size, as determined at each cycle by the maximum mean follicular diameter. After a 3-day dosing error, follicular size was significantly smaller in the patch group (mean, 7.0 mm) vs. each OC group (range of means, 11.8–17.1 mm). Similar results were seen after proper dosing. The incidence of ovulation was significantly lower for the patch users than for women using OCs. Follicular size and incidence of ovulation were significantly reduced among contraceptive patch users compared with women using OCs in normal cycles and after planned dosing errors.
AbstractList To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors.OBJECTIVETo compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors.Randomized, open-label.DESIGNRandomized, open-label.Twelve centers.SETTINGTwelve centers.One hundred twenty-four ovulatory women.PATIENT(S)One hundred twenty-four ovulatory women.Subjects received either the patch (groups 1 and 2) or one of three OCs. Correct dosing occurred in cycles 1, 2, 3, and 5. The following dosing errors were planned during cycle 4, a shortened 10-day cycle: [1] patch group 1 subjects wore one patch for 10 consecutive days; [2] for patch group 2 and OC subjects, 7 dosing days were followed by 3 drug-free days.INTERVENTION(S)Subjects received either the patch (groups 1 and 2) or one of three OCs. Correct dosing occurred in cycles 1, 2, 3, and 5. The following dosing errors were planned during cycle 4, a shortened 10-day cycle: [1] patch group 1 subjects wore one patch for 10 consecutive days; [2] for patch group 2 and OC subjects, 7 dosing days were followed by 3 drug-free days.Follicular size, as determined at each cycle by the maximum mean follicular diameter.MAIN OUTCOME MEASURE(S)Follicular size, as determined at each cycle by the maximum mean follicular diameter.After a 3-day dosing error, follicular size was significantly smaller in the patch group (mean, 7.0 mm) vs. each OC group (range of means, 11.8-17.1 mm). Similar results were seen after proper dosing. The incidence of ovulation was significantly lower for the patch users than for women using OCs.RESULT(S)After a 3-day dosing error, follicular size was significantly smaller in the patch group (mean, 7.0 mm) vs. each OC group (range of means, 11.8-17.1 mm). Similar results were seen after proper dosing. The incidence of ovulation was significantly lower for the patch users than for women using OCs.Follicular size and incidence of ovulation were significantly reduced among contraceptive patch users compared with women using OCs in normal cycles and after planned dosing errors.CONCLUSION(S)Follicular size and incidence of ovulation were significantly reduced among contraceptive patch users compared with women using OCs in normal cycles and after planned dosing errors.
To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing errors. Randomized, open-label. Twelve centers. One hundred twenty-four ovulatory women. Subjects received either the patch (groups 1 and 2) or one of three OCs. Correct dosing occurred in cycles 1, 2, 3, and 5. The following dosing errors were planned during cycle 4, a shortened 10-day cycle: [1] patch group 1 subjects wore one patch for 10 consecutive days; [2] for patch group 2 and OC subjects, 7 dosing days were followed by 3 drug-free days. Follicular size, as determined at each cycle by the maximum mean follicular diameter. After a 3-day dosing error, follicular size was significantly smaller in the patch group (mean, 7.0 mm) vs. each OC group (range of means, 11.8–17.1 mm). Similar results were seen after proper dosing. The incidence of ovulation was significantly lower for the patch users than for women using OCs. Follicular size and incidence of ovulation were significantly reduced among contraceptive patch users compared with women using OCs in normal cycles and after planned dosing errors.
Author Fisher, Alan C
Archer, David F
Shangold, Gary A
Creasy, George W
Pierson, Roger A
Moreau, Michèle
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Issue 1
Keywords Ortho Tri-Cyclen
Evra
follicular development
ethinyl estradiol
norgestimate
Triphasil
Alesse
Ortho Evra
norelgestromin
levonorgestrel
Ethinylestradiol
Human
Toxicity
Levonorgestrel
Oral administration
Norgestimate
Normal
Ovulation
Biological activity
Ovary
Norelgestromin
Female genital system
Female
Contraceptive
Ovarian follicle
Patch
Comparative study
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Snippet To compare the effects of the contraceptive patch to oral contraceptives (OCs) on follicular size and incidence of ovulation in normal cycles and after dosing...
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SubjectTerms Administration, Cutaneous
Administration, Oral
Adolescent
Adult
Alesse
Biological and medical sciences
Contraceptive Agents, Female - administration & dosage
Contraceptive Agents, Female - pharmacology
Contraceptives, Oral, Combined - administration & dosage
Contraceptives, Oral, Combined - pharmacology
Contraceptives, Oral, Hormonal - administration & dosage
Contraceptives, Oral, Hormonal - pharmacology
Estradiol - blood
Estradiol Congeners - administration & dosage
Estradiol Congeners - pharmacology
ethinyl estradiol
Ethinyl Estradiol - administration & dosage
Ethinyl Estradiol - pharmacology
Ethisterone - analogs & derivatives
Evra
Female
Follicle Stimulating Hormone - blood
follicular development
Genital system. Reproduction
Humans
levonorgestrel
Luteinizing Hormone - blood
Medical sciences
Medication Errors
norelgestromin
norgestimate
Norgestrel - analogs & derivatives
Ortho Evra
Ortho Tri-Cyclen
Ovarian Follicle - diagnostic imaging
Ovarian Follicle - drug effects
Ovarian Follicle - physiology
Ovulation - drug effects
Ovulation - physiology
Oximes
Pharmacology. Drug treatments
Progesterone - blood
Triphasil
Ultrasonography
Title Ortho Evra ™/Evra ™ versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0015028203005569
https://dx.doi.org/10.1016/S0015-0282(03)00556-9
https://www.ncbi.nlm.nih.gov/pubmed/12849799
https://www.proquest.com/docview/73440369
Volume 80
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