ethisterone and Headache

A randomized clinical trial was conducted with 239 women at nine clinical research sites to compare bleeding profile, headache frequency, and subject satisfaction with the transdermal contraceptive, ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) used in an extended regimen (84 days) with a traditional, 28-day cyclic regimen. In a majority of women studied, compared with cyclic use, extended use of transdermal norelgestromin/ethinyl estradiol delayed menses and reduced the total incidence of mean headache days during the hormone-free interval.

Topics: Administration, Cutaneous; Adolescent; Adult; Delayed-Action Preparations; Drug Combinations; Ethisterone; Female; Headache; Humans; Middle Aged; Norgestrel; Oximes; Substance Withdrawal Syndrome; Time Factors

The new combined estrogen & progestin contraceptive patch Ortho Evra was approved by the FDA in December 2001. To date, there is a paucity of data regarding its use in the adolescent age group. We examined adolescents' experience with this new contraceptive method.. Using a questionnaire designed by the authors, care providers in a hospital based adolescent clinic interviewed and reviewed the charts of adolescent girls who had initiated Ortho Evra in 2002-2003.. Twenty-eight adolescent girls (age 18 +/- 1 years, gyn age 6 +/- 1 years, onset of sexual intercourse at 14 +/- 1 years, body mass index (BMI) 27.6 +/- 1.2, 57% Hispanic, 21% Caucasian, 11% African American, 7% biracial, 4% Indian American) who had used Ortho Evra for 7 +/- 1 months were enrolled. Half (50%) were adolescent mothers, and 57% had a history of irregular menstrual periods. All (100%) girls reported regular menstrual periods while using Ortho Evra, with only 14% experiencing occasional breakthrough bleeding. Half reported a shorter duration and 36% reported a lighter flow of their periods. About a third (39%) reported a decrease and 11% reported an increase in dysmenorrhea symptoms. About a third (29%) of those with a history of recurrent headaches at initiation reported decrease in headaches, and about a third (33%) of those with acne at initiation reported decrease in facial acne while on Ortho Evra. There were no significant BMI changes during Ortho Evra use. Although condom use while on Ortho Evra was poor (only 15% reporting consistent condom use), there were no pregnancies reported. A majority (93%) reported that they remembered to apply the patches on time, and 40% stated that Ortho Evra was easier than previous contraceptive methods. Two thirds (68%) were very satisfied and 29% were somewhat satisfied with the method, and 93% stated that they would recommend the method to a friend/relative. The preferred application site was the buttock (40%) followed by the lower abdomen (32%). About a fifth (21%) experienced at least one episode of complete patch detachment and 32% reported partial peeling of the patch corners. About a third (32%) would prefer another patch color, and 25% would like a fourth week placebo patch. The most common side effects were mild temporary application site reactions (64%), some discomfort on patch removal (32%), nausea (18%), and breast tenderness (18%). Eleven girls (39%) discontinued Ortho Evra (three lost health insurance, three because of application site reactions, two found patch application schedule difficult to remember, two desired pregnancy, two because of nausea, one because of perceived weight gain).. Ortho Evra provides excellent cycle control in adolescents. Most adolescents are satisfied with this method. Intensive efforts should be made to increase condom use by adolescents on Ortho Evra.

Topics: Abdomen; Acne Vulgaris; Administration, Cutaneous; Adolescent; Attitude to Health; Breast; Buttocks; Condoms; Contraceptives, Oral, Combined; Drug Carriers; Drug Combinations; Dysmenorrhea; Ethisterone; Female; Headache; Humans; Menstrual Cycle; Menstruation; Nausea; Norgestrel; Oximes; Patient Dropouts; Patient Satisfaction