tri-cyclen and Uterine-Hemorrhage

To reassess and compare cycle control attained with two combined hormonal contraceptives, norgestimate (NGM)/ethinyl estradiol (EE) 25 microg and norethindrone acetate (NETA)/EE 20 microg, by new general criteria recommendations for all combined hormonal contraceptives.. Analysis of bleeding data for cycles 1-6 from a randomized, multicenter trial.. 221 North American centers.. Healthy, sexually active women (18-45 years old).. NETA/EE: 1 mg NETA/20 microg EE, days 1-21 of each cycle and 75 mg of ferrous fumarate, days 22-28; NGM/EE: triphasic NGM in 7-day increments (days 1-7: 180 microg; days 8-14: 215 microg; days 15-21: 250 microg) and 25 microg EE, placebo on days 22-28.. Cycle control evaluated from patients' daily diaries.. For cycles 1-6, there was a statistically significant lower incidence of unscheduled bleeding/spotting with NGM/EE 25 microg (range 21.0%-34.4%) than with NETA/EE 20 microg (range 33.0%-46.6%). Of the women who had unscheduled bleeding/spotting, the mean number of days per cycle of bleeding/spotting was comparable. A statistically significant higher incidence of scheduled bleeding was seen with NGM/EE 25 microg (95.2%-97.5%) than with NETA/EE 20 microg (78.5%-84.2%).. The NGM/EE 25 microg has a lower incidence and comparable length of unscheduled bleeding and a higher incidence of scheduled bleeding than NETA/EE 20 microg in this post hoc analysis.

Topics: Administration, Oral; Adolescent; Adult; Contraception; Contraceptives, Oral, Combined; Drug Combinations; Ethinyl Estradiol; Ethinyl Estradiol-Norgestrel Combination; Female; Humans; Menstrual Cycle; Middle Aged; Norethindrone; Norgestrel; Patient Compliance; Practice Guidelines as Topic; Pregnancy; Time Factors; Treatment Outcome; United States; Uterine Hemorrhage; Young Adult

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.

Topics: Adolescent; Adult; Contraceptives, Oral, Combined; Drug Combinations; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norgestrel; Ovulation; Pregnancy; Progesterone; Racial Groups; Uterine Hemorrhage

Estrogen content represents a tradeoff between cycle control and side effects, but few direct comparisons of 20 and 30/35 micrograms preparations are available. 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. Bloating, breast tenderness, and nausea were approximately 50% more common in women using 35 micrograms EE as compared to 20 micrograms EE preparations. Cycle control was similar in all products, although during the first two cycles among starters; users of Mircette and Ortho Tri-Cyclen (Tri-Cyclen) exhibited better cycle control than Alesse users. Discontinuation and pregnancy rates were not significantly higher in 35 micrograms EE users.. Estrogen content represents a tradeoff between cycle control and side effects, but few direct comparisons of 20 and 30/35 mcg preparations are available. To address this issue, researchers conducted a randomized, open-label multicenter clinical trial comparing Alesse (20 mcg ethinyl estradiol [EE]), Mircette (20 mcg EE), and Ortho Tri-Cyclen (35 mcg EE) among 463 oral contraceptive starters or switchers. Bloating, breast tenderness, and nausea were approximately 50% more common in women using 35 mcg EE as in those using 20 mcg EE preparations. Cycle control was similar in all products, although during the first two cycles among starters, users of Mircette and Ortho Tri-Cyclen (Tri-Cyclen) exhibited better cycle control than Alesse users. Discontinuation and pregnancy rates were not significantly higher in 35 mcg EE users.

Topics: Adolescent; Adult; Breast; Contraceptives, Oral, Combined; Desogestrel; Drug Combinations; Estrogens; Ethinyl Estradiol; Female; Hormones; Humans; Menstrual Cycle; Middle Aged; Nausea; Norgestrel; Pregnancy; Statistics, Nonparametric; Uterine Hemorrhage

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).. Prospective, open, non-comparative, multicenter study in 27 centers.. 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.. 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.. 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.

Topics: Adolescent; Adult; Contraceptives, Oral, Hormonal; Drug Combinations; Ethinyl Estradiol; Ethinyl Estradiol-Norgestrel Combination; Female; Humans; Middle Aged; Norgestrel; Patient Compliance; Prospective Studies; Uterine Hemorrhage