tri-cyclen and Headache

Sexual activity is quite common among women aged 14 to 20 in developed countries, averaging perhaps 10% at age 15 to about 70% at 19. Thus, the need for contraception may begin quite early in life and will continue for as long as 30 years. One of the best candidates for long-term contraception for young sexually active females is the oral contraceptive (OC), which provides health benefits besides contraception. Long-term benefits include lowered rates of ovarian and endometrial cancer, as well as of benign breast disease and ovarian cysts. Another benefit is protection against upper-tract sequelae of sexually transmitted diseases. Short-term benefits are correction of menstrual irregularity, reduction in menstrual flow, and diminished premenstrual syndrome and dysmenorrhea. Recent OC formulations contain only one-third the estrogenic potency of older OCs and therefore are associated with dramatic decreases in what were always the major side effects of OCs: heart attack, stroke, and pulmonary embolism. Other side effects of OCs have been most closely associated with the progestogenic component, and are related to the androgenic effects of progestins, particularly some synthetic progestins. However, some new synthetic progestins have been found to have minimal androgen receptor activity in preclinical testing and to cause minimal or no androgen-related side effects in clinical trials. One of these new progestins having a favorable androgenic profile is norgestimate. Its efficacy and safety in combination with low doses of ethinyl estradiol have been documented in the European and the American literature.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acne Vulgaris; Adolescent; Adult; Breast; Contraceptives, Oral, Combined; Contraceptives, Oral, Synthetic; Drug Combinations; Ethinyl Estradiol; Ethinyl Estradiol-Norgestrel Combination; Female; Headache; Humans; Menstrual Cycle; Menstruation; Nausea; Norgestrel; Receptors, Androgen

To determine the effect of oestradiol valerate/dienogest (E2V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs).. This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E2V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28.. In total, 395 were included in the full analysis set (E2V/DNG, n = 191; EE/NGM, n = 204). E2V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; p = 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E2V/DNG vs. 34% EE/NGM).. E2V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.

Topics: Adult; Contraceptives, Oral; Double-Blind Method; Drug Combinations; Estradiol; Ethinyl Estradiol; Female; Headache; Humans; Menstruation; Nandrolone; Norgestrel; Pelvic Pain; Substance Withdrawal Syndrome; Treatment Outcome; Young Adult

An excess of androgen is believed to contribute to development of acne in some patients. Because oral contraceptives (OCs) may reduce the active androgen level, hormonal therapy with OCs has been used successfully to treat patients with acne, although this treatment has previously not been studied in placebo-controlled trials.. Our purpose was to evaluate the efficacy of a triphasic, combination OC (ORTHO TRI-CYCLEN [Ortho-McNeil Pharmaceutical, Raritan, N.J.], norgestimate/ethinyl estradiol) compared with placebo in the treatment of moderate acne vulgaris.. Two hundred fifty-seven healthy female subjects, 15 to 49 years of age with moderate acne vulgaris, were enrolled in a multicenter, randomized, double-blind, placebo-controlled clinical trial. Each month for 6 months, subjects received either 3 consecutive weeks of the OC (i.e., tablets containing a fixed dose of ethinyl estradiol [0.035 mg] and increasing doses of norgestimate [0.180 mg, 0.215 mg, 0.250 mg]) followed by 7 days of inactive drug or placebo (color-matched tablets). Efficacy was assessed by facial acne lesion counts, an investigator's global assessment, a subject's self-assessment, and an analysis of within-cycle variation (cycle 6) in lesion counts.. Of the 160 subjects in whom efficacy could be evaluated, the OC group showed a statistically significantly greater improvement than the placebo group for all primary efficacy measures. The mean decrease in inflammatory lesion count from baseline to cycle 6 was 11.8 (62.0%) versus 7.6 (38.6%) (p = 0.0001), and the mean decrease in total lesion count was 29.1 (53.1%) versus 14.1 (26.8%) (p = 0.0001) in the OC and placebo groups, respectively. In the investigator's global assessment, 93.7% of the active treatment group versus 65.4% of the placebo group were rated as improved at the end of the study (p < 0.001). Six of the seven secondary efficacy measures (total comedones, open comedones, closed comedones, papules, pustules, and the subject's self-assessment of study treatment) were also significantly more favorable in the OC group compared with the placebo group.. An OC containing 0.035 mg of ethinyl estradiol combined with the triphasic regimen of norgestimate is a safe and effective treatment of moderate acne vulgaris in women with no known contraindication to OC therapy.. To evaluate the efficacy of a triphasic combined oral contraceptive (OC) in the treatment of moderate acne vulgaris, 231 healthy US volunteers 15-49 years of age with this dermatologic condition were enrolled in a phase III, multicenter, double-blind, placebo-controlled clinical trial. Each month for 6 months, subjects (n = 110) received either 3 consecutive weeks of Ortho Tri-Cyclen (containing a fixed dose of 0.035 mg of ethinyl estradiol and 0.180, 0.215, and 0.250 mg of norgestimate) followed by 7 days of inactive drug or placebo. The OC group showed significantly greater improvement than controls on all efficacy measures. The mean decrease in inflammatory lesion count from baseline to the sixth cycle was 11.8 (62.0%) among cases and 7.6 (38.6%) in controls, while the mean decrease in total lesion count was 29.1 (53.1%) versus 14.1 (26.8%) in the OC and placebo groups, respectively. In the investigator's global assessment, 93.7% of women in the treatment group and 65.4% of controls were rated as improved at the end of the study. Similarly, more cases than controls considered their acne "improved" at the study's end and expressed a preference for this therapy over other forms of acne treatment. These findings indicate that treatment of moderate acne vulgaris with a low-dose triphasic OC is safe and effective in women with no contraindications to OC use.

Topics: Acne Vulgaris; Adolescent; Adult; Contraceptives, Oral, Combined; Contraceptives, Oral, Synthetic; Double-Blind Method; Drug Combinations; Ethinyl Estradiol; Female; Headache; Humans; Middle Aged; Nausea; Norgestrel; Patient Participation; Prospective Studies; Respiratory Tract Infections; Treatment Outcome