A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial.
A comparative multicenter clinical trial of two low-dose combined oral contraceptives (OCs) was conducted in Malaysia, Egypt, Thailand, and Mexico. Efficacy, safety and acceptability were investigated in women taking either a norgestrel-based (NG) OC or a norethindrone acetate-based (NA) OC. This paper includes analysis of 892 women, all of whom were at least 42 days but within 26 weeks postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had significantly (p < .05) fewer menstrual-related complaints. Discontinuations due to menstrual problems were significantly more common among NA users (primarily amenorrhea). Discontinuations in the NG group were primarily for other personal reasons, e.g. unable to return to the clinic. There was also a significant difference between the two groups for the 11-month gross cumulative life table discontinuation rates due to menstrual problems (p < .01); the NA group had the higher rate.
Dunson
T R
TR
Family Health International, Research Triangle Park, NC 27709.
McLaurin
V L
VL
Israngkura
B
B
Leelapattana
B
B
Mukherjee
R
R
Perez-Palacios
G
G
Saleh
A A
AA
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004244:Dizziness / Q000139:chemically induced; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D019304:Ethinyl Estradiol-Norgestrel Combination; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015993:Life Tables; D008599:Menstruation Disturbances / Q000139:chemically induced; D009640:Norethindrone / Q000008:administration & dosage* / Q000009:adverse effects; D009644:Norgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D010352:Patient Dropouts; D011247:Pregnancy
D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C020416:norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; D009644:Norgestrel; D004997:Ethinyl Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; D009640:Norethindrone