Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new cilest research articles will be listed here shortly after becoming available to us.
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Medical research on cilest
Lakartidningen. 2003 Sep 25; 100(39): 3050-2
Kieler H, Persson I, Odlind V
Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such as venous thromboembolism (VTE), are seldom disclosed until a COC has been on the market for some time. Two new COCs, Yasmin and Cilest have recently been launched in several European countries with expectations of being safer than older COCs. Utilising data from spontaneous reporting of ADRs to the Medical Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest was estimated and compared with VTE incidence for a second (Follimin) and a third generation (Desolett) COC. The reported VTE incidence for Yasmin and Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000 users per year, respectively. The differences were, however, not statistically significant. We conclude that the risk of VTE associated with the most recent COCs is at least similar to that of older COCs.
[Oral contraceptive practices among female medical students of the University of Warsaw]
Ginekol Pol. 2003 Aug; 74(8): 591-5
Radowicki S, Kobielski A
DESIGN: Apparently no researches have been conducted regarding oral contraceptive usage among female medical students in Poland. In the last ten years, all over the world, only five publications have dealt with this topic. OBJECTIVES: The purpose of the research reported in this article was to establish the types, choices and frequency of usage of oral contraceptive pills among female medical students of the University of Warsaw. MATERIAL AND METHODS: 634 female students responded to a specially designed questionnaire. RESULTS: Data collected indicated that, 52.2% of the students have been involved in sexual intercourse. 167 of them used Oral Contraceptive Pills (OCP). Two third survey participants used OCP following a doctors recommendations. CONCLUSIONS: 1.30.5% of the sexually active students used OCP. 2.31.9% of this group of students believed the use of OCP was the most effective of all the contraceptive methods. 3.65.0% of the respondents used OCP following a doctors recommendations. 22.7% of the survey participants used OCP in order to regulate their menstrual cycles. 4. The respondents who reported customary use of OCP cited the most frequently used OCP as: Cilest-28.0%, Mercilon-19.2% and Minulet-13.2%.
Ceska Gynekol. 2003 Mar; 68(2): 84-8
Paseková V, Chroust K
OBJECTIVE: To assess the frequency of irregular intermenstrual bleeding in combined oral contraceptive (ethinylestradiol 35 micrograms/norgestimate 250 micrograms, COC) users and the influence of regularity of pill use on this frequency; to assess the occurrence of withdrawal bleeding during weekends in women using the COC from the first Sunday in the cycle (Sunday start method). DESIGN: Prospective, open, non-comparative, multicenter study in 27 centers. METHODS: The first day of the pill use, occurrence of intermenstrual and withdrawal bleeding and regularity of use were assessed by means of patient's bleeding diary. Body weight, blood pressure and side effects were monitored before the oral contraceptive use and after the third cycle. RESULTS: 358 (94%) of 382 women completed the study. Frequency of intermenstrual bleeding was generally low (6.7%, 5.0% and 5.0% in the first, second and third cycle) and highly influenced by regularity of pill use (2.6%, 0% a 1% in regular users versus 30.2%, 32.1% a 24.2% in irregular users). 28%, 40% and 47% of Sunday start users achieved bleeding-free weekends after the first, second and third cycle. Body weight and blood pressure did not change during the study. CONCLUSION: Frequency of intermenstrual (breakthrough) bleeding during the first three months of COC use is highly influenced by regularity of use. In regular users of monophasic COC containing ethinylestradiol 35 micrograms/norgestimate 250 micrograms the frequency of intermenstrual bleeding is bellow 2.6%. In Sunday start users the proportion of women with bleeding-free weekends (i.e. weekends without the occurrence of withdrawal bleeding) increases to 47% after the third cycle.
Fertil Steril. 2002 Jul; 78(1): 83-9
Auerbach L, Hafner T, Huber JC, Panzer S
OBJECTIVE: To investigate the effects of low-dose oral hormonal contraception on the immune system during certain phases of the hormonal cycle. DESIGN: Prospective, nonrandomized, controlled study. SETTING: Academic research setting. PATIENT(S): Women with regular menstrual cycle using hormonal oral contraception (OC; Cileste, 250 microg of norgestimat and 35 microg of ethinylestradiol, or Marvelon, 150 microg of desogestrel and 30 microg of ethinylestradiol) and women not using hormonal or other forms of contraception. INTERVENTION(S): Peripheral blood lymphocyte subsets were determined by flow cytometry on the first day of menstruation (day 1), in the follicular phase (day 8), midcycle (day 15), and in the luteal phase (day 22). MAIN OUTCOME MEASURE(S): Levels of lymphocyte subpopulations. RESULT(S): Women using OC had significantly higher levels of CD3+ CD8+ cells throughout their pill cycle compared to controls. Furthermore, women taking Cileste had lower levels of natural killer (NK) cells during their cycle and also women taking Marvelon but only from days 8-15. Within the pill cycle of Cileste we observed an increase in CD20+ and CD20+ CD5+ cells from days 1-8. CONCLUSION(S): Cytotoxic lymphocytes, which are responsible for first-line immune defense, and B cells, which are involved in autoimmune disorders, are affected by OC.
Pharmacokinetic overview of Ortho Evra/Evra.
Fertil Steril. 2002 Feb; 77(2 Suppl 2): S3-12
Abrams LS, Skee D, Natarajan J, Wong FA
OBJECTIVE: The pharmacokinetics of norelgestromin, the primary active metabolite of norgestimate, plus ethinyl estradiol (EE), delivered by the once-weekly contraceptive patch (Ortho Evra/Evra), have been studied in eight trials. This overview summarizes the relevant pharmacokinetic data for the contraceptive patch. DESIGN: Review article. RESULT(S): The amount of norelgestromin and EE absorbed from the patch is proportional to patch size: the 20-cm(2) patch (Ortho Evra) delivers norelgestromin, 150 microg/d, and EE, 20 microg/d, to the systemic circulation. After single and multiple applications of the contraceptive patch, daily serum concentrations (area under the serum concentration-versus-time curve) of norelgestromin and EE were within the ranges generally seen with oral norgestimate, 250 microg/EE 35 microg (Ortho-Cyclen/Cilest), but without the peaks and troughs characteristic of oral dosing. Moreover, the contraceptive patch maintains serum concentrations of norelgestromin and EE within these ranges for up to 10 days, suggesting that clinical efficacy would be maintained even if a scheduled change is missed for as long as two full days. Regardless of the location of patch application (abdomen, buttock, upper outer arm, or torso [excluding breasts]) and even under conditions of heat, humidity, exercise, and cool-water immersion, efficacious concentrations of norelgestromin and EE are achieved. Coadministration of the patch with tetracycline did not affect the pharmacokinetics of norelgestromin and EE. CONCLUSION(S): The contraceptive patch exhibits an excellent pharmacokinetic profile, maintaining efficacious serum hormone concentrations under varying conditions.
Am J Obstet Gynecol. 2002 Jan; 186(1): 15-20
Dittrich R, Parker L, Rosen JB, Shangold G, Creasy GW, Fisher AC,
OBJECTIVE: The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated. STUDY DESIGN: In this randomized study, 610 subjects received 10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week. RESULTS: The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P
Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants.
Contraception. 2001 Nov; 64(5): 287-94
Abrams LS, Skee DM, Natarajan J, Wong FA, Lasseter KC
This open-label, randomized study evaluated the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) following the application of a contraceptive patch (1/week) for three cycles (3 weeks/cycle). Healthy women (n = 24) wore a 20-cm(2) patch (ORTHO EVRA/EVRA) on either their abdomen or buttock during blood sampling weeks and on any of four approved sites at other times. Serum was analyzed for NGMN and EE from samples taken during Week 1 of Cycle 1 and Weeks 1-3 of Cycle 3. Steady-state conditions were achieved during the three-cycle study. The patch delivered NGMN and EE at steady-state concentrations within their reference ranges throughout three cycles of treatment; reference ranges are based on studies with ORTHO-CYCLEN/Cilest. Steady-state serum concentrations and area under the curve from 0 to 168 h increased only slightly from Cycle 1, Week 1 to Cycle 3, Week 3 for NGMN and EE, indicating minimal accumulation. Treatment was well tolerated, and patch adhesion was excellent.
Pharmacokinetics of norelgestromin and ethinyl estradiol from two consecutive contraceptive patches.
J Clin Pharmacol. 2001 Nov; 41(11): 1232-7
Abrams LS, Skee DM, Wong FA, Anderson NJ, Leese PT
The primary objective of this open-label study was to determine the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE)following two consecutive applications of a contraceptive patch (ORTHO EVRA/EVRA). Twelve healthy women wore the first patch on their abdomen for 7 days and, after removal at 168 hours (day 7), wore a second patch for 10 days (i.e., 3 days beyond the intended 7-day wear period). Blood samples were collected before and at various times up to 456 hours (day 19) after application of the first patch for analysis of NGMN and EE. 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. No patch detached spontaneously. No subject discontinued or experienced a serious adverse event.
[Changes in the concentration of individual proteins in women using current peroral contraceptives]
Akush Ginekol (Sofiia). 1999; 38(2): 27-9
Ulichkova E, Malinova M, Pekhlivanov B, Sirakova I
BUT: The aim of the present study was to establish the influence of the moderate combined oral contraceptives on the concentration of the individual proteins in serum. MATERIAL AND METHODS: The study included 70 women at the age from 16 to 30, separated into two groups: control group, including 30 women who have not used OC basic group, including 40 women using Cilest and Marvelon in the period of one to three years. There have been examined the following individual proteins in serum: prealbumin; orosomucoid; haptoglobin; TRA; C3; C4; CRP; IgA; IgG and IgM. Their level in serum was defined with immunoturbidimetric method with monoclonal antibodies of the firm Kone (Fin). RESULTS: The data showed reduced concentrations of Orosomucoid and increased concentrations of TRA in the basic group. CONCLUSIONS: The continuous use of Cilest and Marvelon do not influence the concentrations of the examined individual proteins in the serum. They lead to reduced concentrations of orosomucoid and increased concentrations of TRA.
[Current monophasic hormonal contraception]
Akush Ginekol (Sofiia). 1998; 37(2): 9-11
Chernev T, Ivanov S, Sirakov M
Data are presented from an investigation of the use of monophasic contraceptive pills chosen by different age groups. Analyses are made of the data obtained from the Bulgarian Association for Family Planning (BAFP) card index for the last two years. Information is given on the number of observed cycles, type of applied contraceptive pill, aims of their application (contraception, treatment of acne, menstrual disturbances etc.), age of patients, as well as any possible adverse effects--change in blood pressure, bodyweight changes, intermenstrual bleeding, hairiness, breast problems, paraclinical changes, etc. The observed cycles show a very small percentage of adverse effects with hormonal contraception, mainly during the first 2 or 3 cycles, with predominance of intermenstrual bleeding. No bodyweight changes or increased hairiness were observed.