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 in | Fertility and sterility Vol. 80; no. 1; pp. 34 - 42 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
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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. |
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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 |
Author_xml | – sequence: 1 givenname: Roger A surname: Pierson fullname: Pierson, Roger A email: pierson@erato.usask.ca organization: Obstetrics, Gynecology, and Reproductive Sciences, Saskatoon, Saskatchewan, Canada – sequence: 2 givenname: David F surname: Archer fullname: Archer, David F organization: Jones Institute for Reproductive Medicine, Norfolk, Virginia, USA – sequence: 3 givenname: Michèle surname: Moreau fullname: Moreau, Michèle organization: Centre Hospital de l’Universite de Montréal, Móntreal, Qúebec, Canada – sequence: 4 givenname: Gary A surname: Shangold fullname: Shangold, Gary A organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA – sequence: 5 givenname: Alan C surname: Fisher fullname: Fisher, Alan C organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA – sequence: 6 givenname: George W surname: Creasy fullname: Creasy, George W organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA |
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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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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 |
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