Transdermal contraception: evaluation of three transdermal norelgestromin/ethinyl estradiol doses in a randomized, multicenter, dose-response study.
OBJECTIVE
The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated.


METHODS
In this randomized study, 610 subjects received 10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week.


RESULTS
The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P <.001). All regimens had safety profiles typical of oral contraceptives.


CONCLUSIONS
The 20-cm(2) patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance.
Dittrich
Richard
R
Partners in Women's Health, Methodist Hospital, Philadelphia, PA, USA.
Parker
Lamar
L
Rosen
Jeffrey B
JB
Shangold
Gary
G
Creasy
George W
GW
Fisher
Alan C
AC
D000279:Administration, Cutaneous; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000097:blood; D045166:Estradiol Congeners / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D005260:Female; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008597:Menstrual Cycle / Q000187:drug effects; D010053:Ovary / Q000378:metabolism; D010060:Ovulation; D010349:Patient Compliance; D010902:Pituitary Gland / Q000378:metabolism; D012449:Safety
D003271:Contraceptive Agents, Female; D045166:Estradiol Congeners; D004997:Ethinyl Estradiol; D004958:Estradiol; D007986:Luteinizing Hormone