Source: DGNews  |  Posted 8 years ago

By Bruce Sylvester

NEW ORLEANS, LA -- May 5, 2003 -- A new formulation of the oral contraceptive Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) called Ortho Tri-Cyclen LO contains a reduced amount of ethinyl estradiol and appears to cause no adverse weight gain in patients who use it for up to 13 weeks.

Investigators reported these findings in a poster presentation here on April 28th at the 51st Annual Meeting of the American College of Obstetrics and Gynecology.

"We looked at Ortho Tri-Cyclen LO for a potential weight gain side effect over 13 weeks and saw no statistically significant adverse effect on weight," said lead investigator and presenter Ronald Burkman, MD, chairman, department of obstetrics and gynecology, Baystate Medical Center, in Springfield, Massachusetts.

The randomised, parallel-group, multi-center study included 1,723 subjects who received Ortho Tri-Cyclen LO. The mean age of this cohort was 28.2 years, 86.4% of whom were Caucasian and 6.3% African-American.

The mean weight at baseline was 64.2 kg with a mean body mass index of 23.7. At end point, the mean increase in weight from baseline for Ortho Tri-Cyclen LO subjects was 0.75 kg (1.2%) with 83% of the subjects having lost weight, remained the same or less than a 5% increase in weight.

Six women (0.35%) reported significant weight gain and one left the study ascribing her decision to weight gain.

Another contraceptive used in another parallel group in the study, Loestrin