The Experts below are selected from a list of 399 Experts worldwide ranked by ideXlab platform
Alan C Fisher - One of the best experts on this subject based on the ideXlab platform.
-
efficacy safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol
Contraception, 2003Co-Authors: Katherine D Laguardia, Alan C Fisher, Gary A Shangold, Andrew J Friedman, Michael KafrissenAbstract:This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. 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. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. 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. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.
-
transdermal contraception evaluation of three transdermal norelgestromin ethinyl estradiol doses in a randomized multicenter dose response study
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Richard Dittrich, Gary A Shangold, George W Creasy, Lamar Parker, Jeffrey B Rosen, Alan C FisherAbstract:Abstract 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 ≥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 Conclusion: The 20-cm 2 patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance. (Am J Obstet Gynecol 2002;186:15-20.)
-
comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
Contraception, 2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.
-
original research article comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 mg)/ethinyl estradiol 25 mg regimen (Ortho Tri-Cyclen Lo) (n 5 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 mg (Loestrin Fe 1/20) (n 5 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens. © 2001 Elsevier Science Inc. All rights reserved.
George W Creasy - One of the best experts on this subject based on the ideXlab platform.
-
transdermal contraception evaluation of three transdermal norelgestromin ethinyl estradiol doses in a randomized multicenter dose response study
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Richard Dittrich, Gary A Shangold, George W Creasy, Lamar Parker, Jeffrey B Rosen, Alan C FisherAbstract:Abstract 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 ≥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 Conclusion: The 20-cm 2 patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance. (Am J Obstet Gynecol 2002;186:15-20.)
-
comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
Contraception, 2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.
-
original research article comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 mg)/ethinyl estradiol 25 mg regimen (Ortho Tri-Cyclen Lo) (n 5 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 mg (Loestrin Fe 1/20) (n 5 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens. © 2001 Elsevier Science Inc. All rights reserved.
Gary A Shangold - One of the best experts on this subject based on the ideXlab platform.
-
efficacy safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol
Contraception, 2003Co-Authors: Katherine D Laguardia, Alan C Fisher, Gary A Shangold, Andrew J Friedman, Michael KafrissenAbstract:This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN. Among all five regimens, ovulation suppression, cycle control and safety were generally comparable. 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. Breakthrough bleeding and/or spotting (BBS; % total cycles) was 17.2% for ORTHO TRI-CYCLEN Lo and 14.4% for ORTHO TRI-CYCLEN. 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. Thus, ORTHO TRI-CYCLEN Lo appears similar to ORTHO TRI-CYCLEN in inhibiting ovulation and providing cycle control.
-
transdermal contraception evaluation of three transdermal norelgestromin ethinyl estradiol doses in a randomized multicenter dose response study
American Journal of Obstetrics and Gynecology, 2002Co-Authors: Richard Dittrich, Gary A Shangold, George W Creasy, Lamar Parker, Jeffrey B Rosen, Alan C FisherAbstract:Abstract 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 ≥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 Conclusion: The 20-cm 2 patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance. (Am J Obstet Gynecol 2002;186:15-20.)
-
comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
Contraception, 2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.
-
original research article comparison of a novel norgestimate ethinyl estradiol oral contraceptive ortho tri cyclen lo with the oral contraceptive loestrin fe 1 20
2001Co-Authors: Raymond Moss Hampton, Alan C Fisher, Gary A Shangold, Marilyn Short, Eric J Bieber, Celine Bouchard, Normand Ayotte, George W CreasyAbstract:This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 mg)/ethinyl estradiol 25 mg regimen (Ortho Tri-Cyclen Lo) (n 5 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 mg (Loestrin Fe 1/20) (n 5 1,171). Healthy women were treated for up to 13 cycles. Demographics were similar between regimens. Contraceptive efficacy was comparable for Ortho Tri-Cyclen Lo and Loestrin Fe 1/20. The overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. 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. At representative Cycles 1, 3, 6, 9, and 13, breakthrough bleeding and spotting rates were 16.3, 11.5, 10.3, 7.9, and 7.7%, respectively, in the Ortho Tri-Cyclen Lo group and 34.9, 22.9, 22.2, 15.9, and 13.1%, respectively, in the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens. © 2001 Elsevier Science Inc. All rights reserved.
Ronald T Burkman - One of the best experts on this subject based on the ideXlab platform.
-
cycle control tolerability and satisfaction among women switching from 30 35 microg ethinyl estradiol containing oral contraceptives to the triphasic norgestimate 25 microg ethinyl estradiol containing oral contraceptive ortho tri cyclen lo
International journal of fertility and women's medicine, 2003Co-Authors: Ronald T Burkman, Anthony PoindexterAbstract:OBJECTIVE To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg). DESIGN A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 microg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6,054 for Ortho Tri-Cyclen LO and 3,814 for Loestrin Fe 1/20. Additional analyses evaluated switchovers from Ortho Tri-Cyclen to Ortho Tri-Cyclen LO (N = 111). MAIN OUTCOME MEASURES Cycle control was assessed by daily diary cards reporting the frequency, severity, and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire. RESULTS The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1/20. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6%, respectively) and Loestrin Fe 1/20 (3.2% and 0.7%, respectively). More women on Ortho Tri-Cyclen LO versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6, 89.3% of Ortho Tri-Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied, and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conclusions-Switchovers from OCs containing 30-35 microg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability, and were satisfied.
-
cycle control tolerability and satisfaction among women switching from 30 35 micrograms ethinyl estradiol containing oral contraceptives to the triphasic norgestimate 25 micrograms ethinyl estradiol containing oral contraceptive ortho tri cyclen lo
International Journal of Fertility, 2003Co-Authors: A N Poindexter, Ronald T Burkman, A C Fisher, K D LaguardiaAbstract:Objective: To determine cycle control tolerability and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 µg ethinyl estradiol (EE) to Ortho Tri-Cyclen® LO (norgestimate 180/215/250 µg/EE 25 µg) and Loestrin® Fe 1/20 (norethindrone acetate 1 mg/EE 20 µg). Design: A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 µg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6054 for Ortho Tri-Cyclen LO and 3814 for Loestrin Fe 1120. Additional analyses evaluated switchovers from Ortho Tri-Cyclen® to Ortho Tri-Cyclen LO (N = 111). Main Outcome Measures: Cycle control was assessed by daily diary cards reporting the frequency severity and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire. Results: The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1120. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6% respectively) and Loestrin Fe 1/20 (3.2% and 0.7% respectively). More women on Ortho Tri-Cyclen LO Versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6 89.3% of Ortho Tri- Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conelusions--Switchovers from OCs containing 30-35 µg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability and were satisfied. (authors)
K D Laguardia - One of the best experts on this subject based on the ideXlab platform.
-
cycle control tolerability and satisfaction among women switching from 30 35 micrograms ethinyl estradiol containing oral contraceptives to the triphasic norgestimate 25 micrograms ethinyl estradiol containing oral contraceptive ortho tri cyclen lo
International Journal of Fertility, 2003Co-Authors: A N Poindexter, Ronald T Burkman, A C Fisher, K D LaguardiaAbstract:Objective: To determine cycle control tolerability and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 µg ethinyl estradiol (EE) to Ortho Tri-Cyclen® LO (norgestimate 180/215/250 µg/EE 25 µg) and Loestrin® Fe 1/20 (norethindrone acetate 1 mg/EE 20 µg). Design: A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 µg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6054 for Ortho Tri-Cyclen LO and 3814 for Loestrin Fe 1120. Additional analyses evaluated switchovers from Ortho Tri-Cyclen® to Ortho Tri-Cyclen LO (N = 111). Main Outcome Measures: Cycle control was assessed by daily diary cards reporting the frequency severity and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire. Results: The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1120. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6% respectively) and Loestrin Fe 1/20 (3.2% and 0.7% respectively). More women on Ortho Tri-Cyclen LO Versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6 89.3% of Ortho Tri- Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conelusions--Switchovers from OCs containing 30-35 µg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability and were satisfied. (authors)
