Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol.
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.
LaGuardia
Katherine D
KD
Ortho-McNeil Pharmaceutical, Inc., Women's Health Care, 1000 Route 202, PO Box 300, Raritan, NJ 08869-0602, USA. Klguard@ompus.jnj.com
Shangold
Gary
G
Fisher
Alan
A
Friedman
Andrew
A
Kafrissen
Michael
M
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
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C109079:norgestimate, ethinyl estradiol drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D011374:Progesterone; C017576:norgestimate