Disease relevance of Tricileste

• Breakthrough bleeding and spotting was reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group [1].
• Two multicenter, double-blind, placebo-controlled studies were conducted to evaluate the effectiveness of triphasic norgestimate/ethinyl estradiol (Ortho Tri-Cyclen) for the treatment of acne vulgaris [2].

High impact information on Tricileste

• Mean serum concentrations of NGMN and EE remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, during the entire 7-day wear period after application of the first patch and for 10 days after application of the second patch; reference ranges are based on studies with ORTHO-CYCLEN/ Cilest [3].
• Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN [4].
• Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control [4].
• 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 [4].
• To address this issue, we conducted a randomized, open-label multicenter clinical trial comparing Alesse (20 micrograms ethinyl estradiol [EE]), Mircette (20 micrograms EE), and Ortho Tri-Cyclen (35 micrograms EE) among 463 OC starters or switchers [5].

Chemical compound and disease context of Tricileste

• OBJECTIVE: This was a postmarketing, retrospective, exploratory analysis to investigate the duration of response to a triphasic combination oral contraceptive (OC) (Ortho Tri-Cyclen; Ortho-McNeil Pharmaceutical, Raritan, NJ) [norgestimate-ethinyl estradiol]) in the treatment of moderate acne vulgaris [6].

Associations of Tricileste with other chemical compounds

• 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 [4].

References