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Biomedical subjects

Andrew J Friedman

Publications and source records attributed to Andrew J Friedman.

7 recordsLinked to original sources
PubMed2006

ORTHO birth control satisfaction assessment tool: assessing sensitivity to change and predictors of satisfaction.

OBJECTIVE: To test the sensitivity to change of the ORTHO Birth Control Satisfaction Assessment Tool (ORTHO BC-SAT) among dissatisfied women switching to a new hormonal birth control method and to better understand which factors contribute to a woman's satisfaction with the method. MATERIALS AND METHODS: Women switching to a new hormonal birth control method [oral contraceptives (OCs), injections, vaginal ring or transdermal patch] completed the ORTHO BC-SAT, a questionnaire measuring satisfaction, two times over a 3-month period. Sensitivity to change was measured by examining change scores, as well as the Guyatt's statistic. Predictors of satisfaction were examined using forward-stepping linear regression. RESULTS: Fifty-six women completed the ORTHO BC-SAT twice. With the exception of Future Fertility Concerns, women reported statistically significant improvements on all scales of the questionnaire. The scales most sensitive to change were Overall Satisfaction, Assurance/Confidence, Lifestyle Impact, and Ease of Use/Convenience. Being older, switching from a nonhormonal method of birth control at baseline and more bodily pain at baseline predicted the increase in satisfaction scales. CONCLUSION: The ORTHO BC-SAT has demonstrated sensitivity to change in this population. In addition, we identified several factors at baseline that predicted an increase in satisfaction scale scores.

Adolescent↗
PubMed2006

Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study.

PURPOSE: To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS). METHODS: Females 11-17 years of age with AN or EDNOS entered the study. Subjects were randomized equally to treatment with a triphasic OC containing norgestimate (NGM) 180-250 microg and ethinyl estradiol (EE) 35 microg or placebo for 13 28-day cycles. Dual energy x-ray absorptiometry scans (DXA) of the lumbosacral spine (LS) and hip were obtained at baseline and after 6 and 13 cycles. RESULTS: Demographic characteristics of the 112 subjects (NGM/EE 53; Placebo 59) who received study drug and had at least one on-treatment DXA were similar between groups for age (mean: 15 years in each group) and body mass index (mean: NGM/EE 17.9 kg/m2; Placebo 17.6 kg/m2). At the end of Cycle 6, there was a significant increase in the mean LS BMD in the NGM/EE group compared with placebo (.020 g/cm2 vs. .008 g/cm2; p = .021); however, at the end of Cycle 13 the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). There was no significant difference in change in hip BMD between groups. The incidence of adverse events was similar between groups. CONCLUSIONS: In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.

Adolescent↗
PubMed2006

Effects of E2 and E2/norgestimate hormone therapy on elevated baseline lipids.

OBJECTIVE: To evaluate lipid effects of estradiol/ norgestimate hormone therapy in postmenopausal women with elevated lipid levels. STUDY DESIGN: Postmenopausal women were randomized to E2, 1 mg/intermittent norgestimate (NGM) 90 microg (n = 31), or opposed E2, 1 mg (n = 36), in a 12-month trial. A subset analysis was conducted on participants with unfavorable baseline lipid levels, either total cholesterol (TC) levels > 200 mg/dL, high-density lipoprotein cholesterol (HDL-C) levels < 40 mg/dL, low-density lipoprotein cholesterol (LDL-C) levels > or = 160 mg/dL or triglyceride levels > or = 150 mg/dL. Mean changes and categorical shifts were assessed on fasting blood samples collected at baseline and at 7 and 12 months. RESULTS: Twelve-month mean changes from baseline in women treated with E2/NGM included a 19.8% increase in HDL-C and decreases of 13.4% in LDL-C, 17.5% in triglycerides and 3.3% in TC. Women with poorer lipid profiles at baseline showed the greatest benefit. Results were similar in women randomized to unopposed E2. CONCLUSION: E2/NGM and unopposed E2 were similarly beneficial in modifying lipid fractions in women with unfavorable baseline levels.

Adult↗
PubMed2005

Suppression of estrogen-withdrawal headache with extended transdermal contraception.

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.

Administration, Cutaneous↗
PubMed2005

Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial.

OBJECTIVE: To compare bleeding profiles and satisfaction among women using a norelgestromin/ethinyl estradiol (E2) transdermal contraceptive patch in an extended regimen to those among women using a traditional 28-day patch regimen. METHODS: Healthy, regularly menstruating women (N = 239) were randomly assigned (2:1 ratio) to receive the norelgestromin/ethinyl E2 transdermal patch in an extended regimen (weekly application for 12 consecutive weeks, 1 patch-free week, and 3 more consecutive weekly applications, n = 158) or a cyclic regimen (4 consecutive cycles of 3 weekly applications and 1 patch-free week, n = 81). Subjects recorded bleeding data daily and completed satisfaction questionnaires. Subjects and investigators provided overall assessments of the regimens. RESULTS: Extended use of the norelgestromin/ethinyl E2 transdermal patch resulted in fewer median bleeding days (6 compared with 14, P < .001), bleeding episodes (1 compared with 3, P < .001), and bleeding or spotting episodes (2 compared with 3, P < .001) compared with cyclic use during days 1-84; median numbers of bleeding or spotting days were similar between regimens (14 compared with 16, P = .407) during this time. Extended use delayed median time to first bleeding to 54 days compared with 25 days with cyclic (P < .001). Subjects were highly satisfied with both regimens. Although not statistically significant, slightly more adverse events were reported with the extended than with the 28-day regimen. CONCLUSION: Compared with cyclic use, extended use of the norelgestromin/ethinyl E2 transdermal patch delayed menses and resulted in fewer bleeding days. This regimen may represent a useful alternative for women who prefer fewer episodes of withdrawal bleeding.

Administration, Cutaneous↗
PubMed2003

Norelgestromin as selective estrogen enzyme modulator in human breast cancer cell lines. Effect on sulfatase activity in comparison to medroxyprogesterone acetate.

Human breast cancer tissue contains enzymes (estrone sulfatase, 17beta-hydroxysteroid dehydrogenase, aromatase) involved in the last steps of estradiol (E(2)) formation. In this tissue, E(2) can be synthesized by two main pathways: (1) sulfatase-transforms estrogen sulfates into bioactive E(2), and the (2) aromatase-converts androgens into estrogens. Quantitative assessment of E(2) formation in human breast tumors indicates that metabolism of estrone sulfate (E(1)S) via the sulfatase pathway produces 100-500 times more E(2) than androgen aromatization. In the present study, we demonstrated in T-47D and MCF-7 human breast cancer cells that norelgestromin (NGMN) (a metabolite of norgestimate) is a potent inhibitory agent of the estrone sulfatase activity. After 24h incubation of physiological concentrations of E(1)S (5 x 10(-9)mol/l) the inhibitory effect of NGMN at concentrations of 5 x 10(-9), 5 x 10(-7) and 5 x 10(-5)mol/l was 43+/-7, 74+/-4 and 97+/-2%, respectively, in T-47D cells; 25+/-4, 57+/-5 and 96+/-2% respectively, in MCF-7 cells. Comparative studies using medroxyprogesterone acetate (MPA) showed that this progestin also has an inhibitory effect on sulfatase activity, but significantly less intense than that of NGMN. The inhibition for MPA at concentrations of 5 x 10(-9), 5 x 10(-7) and 5 x 10(-5)mol/l was 31+/-5, 47+/-3 and 61+/-3%, respectively, for T-47D cells; 6+/-3, 20+/-3 and 63+/-4%, respectively, for MCF-7 cells. In conclusion, the present data show that NGMN is a very potent inhibitory agent for sulfatase activity in the hormone-dependent breast cancer cells, resulting in decreased tissue concentration of E(2). The clinical significance of this finding remains to be elucidated.

Antineoplastic Agents, Hormonal↗