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Title: Ortho Tri-Cyclen LO (Norgestimate/Ethinyl Estradiol) Shows No Effect on Body Weight Up to 13 Weeks: Presented at ACOG

"Ortho Tri-Cyclen LO (Norgestimate/Ethinyl Estradiol) Shows No Effect on Body Weight Up to 13 Weeks: Presented at ACOG"

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 Ž Fe 1/20 (ethinyl estradiol and norethindrone) also produced no statistically significant weight gain in the 1,171 subjects using it. "These results suggest that Ortho Tri-Cyclen LO and Loestrin Fe 1/20 have no significant effect on body weight when used up to 13 cycles, the authors concluded, "Discontinuation rates with Ortho Tri-Cyclen LO were low and comparable to Loestrin Fe 1/20, indicating that both regimens were well tolerated." Dr. Burkman added, "Weight gain is about diet for those who use these agents, not about an undesirable effect of the contraceptives." Johnson and Johnson Pharmaceutical Research and Development supported the study. [Study title: An Assessment of ORTHO TRI-CYCLENŽ LO on Body Weight and Study Discontinuation. Poster :12]

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