title: Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol.
abstract: This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. Presumed ovulation (serum progesterone levels >or=3 ng/mL during Days 19-21 of Cycle 3), occurred in 0/41 (0%) subjects on ORTHO TRI-CYCLEN Lo and 3/43 (7%) subjects on ORTHO TRI-CYCLEN. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. The mean number of days of BBS/cycle for ORTHO TRI-CYCLEN Lo and ORTHO TRI-CYCLEN was 3.7 and 3.1, respectively, for those subjects with such bleeding. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.
authors.affiliation: Ortho-McNeil Pharmaceutical, Inc., Women's Health Care, 1000 Route 202, PO Box 300, Raritan, NJ 08869-0602, USA. Klguard@ompus.jnj.com
authors.forename: Katherine D
authors.initials: KD
authors.lastname: LaGuardia
authors.forename: Gary
authors.initials: G
authors.lastname: Shangold
authors.forename: Alan
authors.initials: A
authors.lastname: Fisher
authors.forename: Andrew
authors.initials: A
authors.lastname: Friedman
authors.forename: Michael
authors.initials: M
authors.lastname: Kafrissen
mesh_terms: D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D010060:Ovulation; D011247:Pregnancy; D011374:Progesterone / Q000097:blood; D044469:Racial Groups; D014592:Uterine Hemorrhage
chemical_list: D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C109079:norgestimate, ethinyl estradiol drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D011374:Progesterone; C017576:norgestimate