Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new ortho-cyclen research articles will be listed here shortly after becoming available to us.
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Medical research on ortho-cyclen
Psychoneuroendocrinology. 2007 Apr; 32(3): 246-55
Graham CA, Bancroft J, Doll HA, Greco T, Tanner A
The aim of this study was to examine whether changes in plasma androgen levels (total testosterone (T), free testosterone (FT), and dehydro-epiandrosterone-sulfate (DHEA-S)) induced by oral contraceptive (OC) use were related to changes in sexual interest or response or in mood. Sixty-one women provided blood samples and were assessed, using interviews and standardized questionnaires, prior to starting, and after 3 months on OCs (Ortho-Tricyclen, Ortho-Tricyclen-Lo, or Ortho-Cyclen, all containing the same progestagen, norgestimate). Significant decreases in T, FT, and DHEA-S were found after 3 months, although the extent of reduction was variable across women. There was some support for a relationship between the degree of reduction in total T and FT and the frequency of sexual thoughts after 3 months on OCs. However, some women had no loss of sexual interest in spite of substantial reduction in FT, and there was overall no evidence that reduction in FT affected enjoyment of sexual activity with a partner. The findings are consistent with the idea that some women may be more sensitive to changes in T than others. No relationship was found between negative mood, as assessed by the Beck Depression Inventory, and changes in T, FT, or DHEA-S.
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.
New progestin oral contraceptives and the female condom.
Pediatr Ann. 1995 Apr; 24(4): 211-6
Gold MA
Clinical experience with a new norgestimate-containing oral contraceptive.
Int J Fertil. 1992; 37 Suppl 1: 47-53
Huber J
Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
Clinical experience with a new norgestimate-containing oral contraceptive.
Int J Fertil. 1991; 36 Suppl 1: 25-31
Huber J
Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
Supportive European data on a new oral contraceptive containing norgestimate.
Acta Obstet Gynecol Scand Suppl. 1990; 152: 33-9
Becker H
Several European studies have been conducted to confirm the efficacy, tolerability, and safety of a new oral contraceptive (OC) combining 250 micrograms norgestimate with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). In a 12-month multicenter German study of 147 women, treatment with this formulation resulted in no pregnancies, a low incidence of side effects, and excellent cycle control. The drug had no effect on estrogen-mediated fibrin formation nor on the activity of coagulation inhibiting or promoting factors. Similarly, the documented low androgenicity of the highly selective progestational agent norgestimate results in a more positive metabolic profile. Glucose, insulin, and hemoglobin A1c concentrations measured before and after glucose loading were not adversely affected by treatment with the norgestimate-containing OC, and all changes were reversible on its discontinuation. In addition, lipid metabolism was positively influenced by the drug. Low-density lipoprotein cholesterol, a known risk factor for cardiovascular disease, was reduced while the cardioprotective lipid fraction, high-density lipoprotein cholesterol, was increased. Clinical trials to determine the OC's effects on coagulation, endocrine function, and carbohydrate and lipid metabolism are reviewed. Also discussed are several studies demonstrating the formulation's unique endometrial effects, which may possibly be related to its low androgenic activity and consequent low incidence of breakthrough bleeding and amenorrhea.
Acta Obstet Gynecol Scand Suppl. 1990; 152: 25-31
Corson SL
The search for a highly selective progestin that exerts a potent and targeted progestational response with minimal or absent androgenic effect has paralleled investigation into the possible impact of these agents on cardiovascular disease in women. Such a progestin, norgestimate (NGM), in a dose of 250 micrograms, has been combined with ethinyl estradiol (EE) 35 micrograms in a new oral contraceptive (OC), Ortho-Cyclen or Cilest. Results of two long-term, multicentric clinical trials demonstrate that this formulation is comparable in efficacy to the norgestrel-containing OC Lo/Ovral. There were no statistically significant differences in pregnancy rate, and both OCs were well-tolerated in a large and diverse study population. In several areas, however, the inherently lower androgenicity of the norgestimate OC produced clinical changes compared with the norgestrel formulation. These changes were primarily evident in the more natural menstrual patterns with the norgestimate OC, its less severe impact on the endometrium, and, most important, its positive impact on lipoprotein metabolism. NGM/EE consistently produced statistically significant increases in high density lipoprotein (HDL) and concomitant improvement in the ratio of low density lipoprotein (LDL) to HDL. By cycle 24, this highly predictive parameter of atherosclerotic risk had decreased 7.7% in the NGM/EE group. Conversely, the norgestrel-containing formulation resulted in statistically significant decreases in HDL and increases in the LDL/HDL ratio; by cycle 24, these patients showed an 18.5% increase in the LDL/HDL ratio. All between regimen comparisons of mean changes in the LDL/HDL ratio were statistically significant, from baseline through cycles 3, 6, 12 and 24.