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Biomedical subjects

Patricia J Sulak

Publications and source records attributed to Patricia J Sulak.

14 recordsLinked to original sources
PubMed2006

Oral contraceptives and premenstrual symptoms: comparison of a 21/7 and extended regimen.

OBJECTIVE: The purpose of this study was to assess the incidence and severity of premenstrual-type symptoms in patients converted from a 21/7 oral contraceptive (OC) regimen to an extended regimen. STUDY DESIGN: This was a single center prospective analysis of the single item Scott and White (S&W) Mood Scale and the Penn State Daily Symptom Report (DSR17) during a 21/7-day followed by a 168-day extended regimen of an OC containing 3 mg of drosperinone and 30 microg of ethinyl estradiol (DRSP/EE). RESULTS: Of the 114 patients who began the study, 111 completed the preextension 21/7 phase of the study. There were significant differences in severity in the DSR17 and the S&W mood scale among days of the cycle. (P < .0001) The highest values in both scales occurred during the 7-day hormone free interval (HFI) of the 21/7 cycles (P < .001). Of the 111 patients who completed the 21/7 phase of the study, 102 (92%) completed the 168-day extended regimen. During the extended phase of the study, subjects were divided into 2 groups: those with a 100% increase in symptoms from the first half to the second half of the last 21/7 cycle were labeled as high cyclic variability, whereas those with lesser or no cyclic change were labeled as low cyclic variability. There were 55 (54%) with increased cyclic variability in mood scores peaking during the 7-day HFI. Premenstrual-type symptoms measured by both the S&W mood scale and the DSR17 instrument decreased during the extended DRSP/EE OC regimen (P < .0001) compared with the preceding 21/7 cycle, with the greatest improvement detected in the sixth month of continuous OCs (P < .003). The patient group with greatest cyclic variability during the 21/7 regimen demonstrated the most improvement during the 168-day regimen (P < .0001). The single item S&W mood scale was significantly (P < .05) correlated to each of 17 elements of the DSR17 with Spearman R correlation coefficients of 0.25 to 0.57. The greatest correlation coefficient (Spearman's R = 0.66) is with the sum of all 17 items. CONCLUSION: A 168-day extended regimen of DRSP/EE led to a decrease in premenstrual-type symptoms compared with the 21/7-day regimen.

Adult↗
PubMed2006

Prospective analysis of occurrence and management of breakthrough bleeding during an extended oral contraceptive regimen.

OBJECTIVE: The purpose of this study was to assess the bleeding patterns of an extended oral contraceptive (OC) regimen and management of breakthrough bleeding/breakthrough spotting (BTB/BTS). STUDY DESIGN: This was a single-center prospective analysis of self-rated menstrual flow during a 21/7-day versus a 168-day extended regimen of on OC containing 3 mg of drosperinone and 30 mcg of ethinyl estradiol (DRSP/EE) with institution of a randomized protocol to manage BTB/BTS. RESULTS: Of the 111 patients initiating the extended OC regimen, 102 (92%) completed the 168-day regimen. Subjects having a heavier daily flow rating during the 21/7-day pre-extension cycle had greater daily flow ratings (P < .001) and tended to have earlier occurrence of BTB during the extended regimen (P = .07) than subjects with lighter daily flow ratings. If BTB/BTS of at least 7 consecutive days occurred, patients were randomized to taking a 3-day hormone free interval (HFI) versus continuing active pills. Instituting a 3-day HFI was significantly more effective in resolving BTB/BTS than continuing active pills (P < .0001). Patients with heavier daily flow ratings during the 21/7-day cycle were not more likely to be randomized for BTB/BTS than those with lighter flow ratings (P = .53). CONCLUSION: A 168-day extended regimen of DRSP/EE had an acceptable bleeding profile with a high continuation rate. Bleeding during the extended cycle was effectively managed with institution of a 3-day HFI.

Adolescent↗
PubMed2006

Greater inhibition of the pituitary--ovarian axis in oral contraceptive regimens with a shortened hormone-free interval.

OBJECTIVE: Our objective was to test the hypothesis that shortening the hormone-free interval (HFI) between cycles of 21 days of oral contraceptives (OCs) reduces pituitary secretion of gonadotropins and ovarian production of estradiol and inhibin-B. DESIGN: We used a prospective trial design comparing the standard 7-day HFI and shortened HFI during cycles, with an OC containing 0.03 mg of ethinyl estradiol and 3 mg of drospirenone. METHODS: Twelve current OC users initially utilized an OC in the standard fashion, with 21 days of active pills and a 7-day HFI, followed by 21 days of active pills with randomization to either a 3-day or a 4-day HFI. Nine daily blood samples were obtained for the measurement of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol and inhibin-B, beginning with active pill 21 days before each HFI of the two cycles. Analysis of variance was used to compare hormones for 9 days bracketing the standard 7-day HFI and to compare, within individuals, the 7-day HFI and the subsequent shortened HFI. RESULTS: During the 7-day HFI, all four hormones significantly (p>.001) increased from baseline. FSH increased beginning on HFI Day 4, inhibin-B increased beginning on HFI Day 5, and LH and estradiol increased beginning on HFI Day 6. Subjects randomized to the 3-day or the 4-day HFI did not differ with regard to age and body size (p=.88) or initial hormone level (p=.67). Greater pituitary and ovarian suppression was seen with the shortened HFI for all four hormones (p<.001). Hormone levels in the 7 days after the last active pill of the second cycle did not differ (p>.4) between the 3-day and the 4-day HFI groups. CONCLUSIONS: Shortening the HFI from 7 days to 3 or 4 days blunts increases in the pituitary-ovarian axis during cycles of OC use.

Adult↗
PubMed2006

Impact of an adolescent sex education program that was implemented by an academic medical center.

OBJECTIVE: The purpose of this study was to assess changes in knowledge and attitudes before and after a large-scale sex education curriculum that was implemented by an academic medical center. STUDY DESIGN: Middle school students were surveyed regarding demographics, knowledge, attitudes, and behaviors. All grade levels at each campus completed a presurvey on the same day before any of the 2-week curricula were received. Postsurveys were taken on the day after the last lesson. RESULTS: Surveys were completed by 26,125 students before and 24,550 students after a sex education curriculum. Knowledge improved (P < .001) for all grades, based on paired comparisons for each group. Although most students chose the option to wait until after high school graduation to have sex, significantly more students held this opinion after the program (P < .0001). Variables that were associated with the attitude of delaying sex included making a pledge (odds ratio, 7.4; 95% CI, 6.7-8.2), original parents still married (odds ratio, 1.6; 95% CI, 1.1-2.1), attending weekly religious/church services (odds ratio, 1.5; 95% CI, 1.3-1.6), and watching 0 to 2 hours of television on school nights (odds ratio, 1.4; 95% CI, 1.2-1.5). Self-reported "less than C" students showed the least knowledge improvement and the belief that teens should "have sex whenever they want" at a greater percentage than other academic levels. CONCLUSION: Implementation of a sex education curriculum by an academic medical center to adolescents resulted in increased knowledge and a shift in attitude toward delaying sexual activity.

Academic Medical Centers↗
PubMed2005

The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days.

OBJECTIVE: To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin [30 microg ethinylestradiol (EE) and 3 mg drospirenone (DRSP)]. METHODS: Using daily diaries, 177 women recorded bleeding events throughout the 126-day cycle. At end of treatment, the women completed questionnaires reflecting their satisfaction with the extended regimen. A subset of 30 women underwent endometrial histology sampling after completion of the extended regimen. RESULTS: Of 177 women assigned to the extended regimen, 80.8% completed the extended 126-day regimen. Approximately 40% of the women reported complete absence of bleeding, while in 60% a shift towards less intense bleeding was observed. The first onset of bleeding occurred after a median of 99.0 days into the extended cycle. The acceptance of the extended regimen was high, with 68.4% of the women expressing satisfaction. The general safety profile with the extended use was comparable to that seen with the conventional 21+7-day regimen. All endometrial biopsies with sufficient material for analysis were normal and supported the endometrial safety of the extended regimen. CONCLUSION: This study showed that the continuous use of a 30-microg EE and 3-mg DRSP formulation over 126 days was safe, efficacious, well accepted by the users and resulted in a considerable reduction of bleeding.

Adult↗
PubMed2005

Attitudes and prescribing preferences of health care professionals in the United States regarding use of extended-cycle oral contraceptives.

OBJECTIVE: The aim of this study was to examine the attitudes and prescribing patterns of health care professionals (HCPs) in the United States regarding extended continuous oral contraceptive (OC) regimens. DESIGN: A prospective survey of HCPs prescribing contraception who attended six educational conferences from April to July 2004 was conducted. METHODS: A survey instrument that included demographic variables, attitudes and prescribing preferences regarding extended OC regimens was developed. Surveys were administered at medical meetings to a diverse array of HCPs who specifically prescribe contraception in their practice. The survey was conducted immediately prior to a presentation at the medical meetings on contraceptive update. Returned forms were scanned into Excel databases and examined with Pearson's chi(2) and multivariate logistic regression methods to assess practices and attitudes. RESULTS: There were 551 HCPs, including primary care physicians, obstetrician/gynecologists, nurse practitioners and physician assistants, prescribing contraception who were surveyed at the medical meetings. Most of the participants (87.4%) thought that extended OC regimens should be routinely offered, with 81% of the respondents reporting that they had used extended regimens in their practice. Physicians and nurse practitioners who listed their specialty as "OB/GYN" were more likely to favor the concept of routinely offering the option of extended regimens (p<.0002) and to have recommended extended regimens in their practice (OR = 2.9, 95% CI = 1.8-4.6). Only 12% of the respondents thought that withdrawal bleeding with standard 21-day/7-day OC regimens "has health benefits and is necessary." The most commonly recommended extended regimen was an 84-day active pill use period followed by a 7-day hormone-free interval. CONCLUSION: Most HCPs prescribing contraception who attended the six medical meetings favored the use of extended OC regimens and have recommended them in their practice, especially if their specialty was OB/GYN. The most commonly prescribed extended regimen was an 84-day active pill use period followed by a 7-day hormone-free interval.

Attitude of Health Personnel↗
PubMed2005

Analysis of knowledge and attitudes of adult groups before and after attending an educational presentation regarding adolescent sexual activity.

OBJECTIVE: To assess changes in knowledge and attitudes of adult groups before and after attending an educational presentation on adolescent sexual health. STUDY DESIGN: A diverse group of adults attended the presentations and completed a presurvey and postsurvey containing 10 knowledge questions, 3 opinion questions, and demographics. RESULTS: Survey forms were completed by 3661 participants before and 3605 participants after 62 educational programs during the 2002 to 2003 school year. Adult participants consisted of school employees, adults attending parent presentations, health care professionals, adults at community presentations, and teachers. Presurveys revealed a significant lack of information by all groups, with health care professionals answering 37.9% and other adults answering 30.2% correct. All groups demonstrated significant (P = .0005) improvements in knowledge and a shift in attitude, favoring the delay of sexual activity until at least after high school from 94% before the survey to 98% after the survey (P < .0001) and the delay until marriage from 77% to 91.5% (P < .0001). CONCLUSION: Educating adults on the ramifications of adolescent sexual activity results in significant increases in knowledge and the proportion who think teens should delay sexual activity.

Adolescent↗
PubMed2005

Ovulation suppression of premenstrual symptoms using oral contraceptives.

Managing premenstrual symptoms at the most fundamental level necessitates careful consideration of female reproductive biology. Inhibiting ovulation using hormonal agents is a reasonable approach for reducing premenstrual symptoms, but the benefits of agents such as gonadotropin-releasing hormone agonists and the synthetic androgen danazol are largely offset by their adverse effects and costs. Combination oral contraceptives provide an alternative that is widely accepted by women experiencing premenstrual symptoms and by their physicians; and newer formulations with lower levels of estrogen and progestin, administered using a monthly regimen with a shortened pill-free interval, appear promising for alleviating patient distress from severe premenstrual symptoms.

Adolescent↗
PubMed2004

Outcomes of extended oral contraceptive regimens with a shortened hormone-free interval to manage breakthrough bleeding.

OBJECTIVE: To evaluate in a clinical practice setting the acceptance, continuation and variability of extending the active interval of oral contraceptives (OCs) with introduction of a shortened hormone-free interval (HFI) to manage breakthrough bleeding. METHODS: A retrospective review was undertaken of patients seen by one obstetrician/gynecologist and counseled on extending the active interval of OCs with a shortened HFI of 3-4 days to manage bleeding. Electronic medical records were searched for the phrase "extending the number of active pills" for patients counseled between January 1, 2000, and January 31, 2003, with follow-up through January 31, 2004. A structured query of each patient's initial and follow-up records was performed. RESULTS: The 220 patients counseled on the extended regimen were 14-52 years of age (mean 36.4, SD 9.3 years). At initial counseling before extending, the majority of patients cited more than one reason for using OCs in the standard fashion with 59% using OCs for noncontraceptive reasons. Reasons for extending the active interval of OCs included premenstrual symptoms (45%), dysmenorrhea/pelvic pain (40%), heavy withdrawal bleeding (36%), menstrual associated headaches (35%), convenience (13%), acne associated with menses (10%) and other (15%). Of the 181 patients with follow-up data, 174 (96%) attempted an extended regimen with 121 (67%) continuing to do so at last follow-up. Follow-up intervals ranged from 0.3 to 3.8 years (mean 1.6 years). Using Kaplan-Meier product limit survival analysis, 60% of patients continued using extended patterns of OCs for more than 2 years. For 121 currently extending, the HFI varied from 0 to 7 days with 88% utilizing a 0 to 4 day HFI. CONCLUSIONS: Sixty percent of patients offered extending the active interval and shortening the HFI of OCs initiate and continue this pattern for more than 2 years without serious sequelae or pregnancy while individually directing both the number of days of continuous pills and the length of the HFI.

Adolescent↗
PubMed2004

Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone.

The aim of this open-label, multicenter, noncomparative study was to determine the efficacy, safety and bleeding profile of a new low-dose, monophasic combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone administered daily for 24 days followed by a 4-day hormone-free interval. Contraceptive efficacy was analyzed for 1018 women completing 11,140 treatment cycles. Eleven pregnancies occurred, giving a Pearl Index (PI) of 1.29 (upper limit of the 95% confidence interval [CI], 2.30); of these pregnancies, five were considered due to method failure, giving an adjusted PI of 0.72 (upper limit of the 95% CI, 1.69). A total of 7 (0.7%) women discontinued study medication because of irregular bleeding, suggesting a favorable bleeding profile. Overall, the treatment was well tolerated with an excellent safety profile. The majority of women (86%) stated that they were satisfied or very satisfied with the treatment and over 70% of women would have continued with the study medication.

Adolescent↗
PubMed2003

Sexually transmitted diseases.

Sexually transmitted diseases (STDs) constitute a major health burden in the United States, causing pelvic inflammatory disease, ectopic pregnancy, infertility, chronic pelvic pain, genital lesions, genital neoplasms, adverse pregnancy outcomes, immune system dysfunction, liver disease, and even death. STDs disproportionately affect adolescents and young adults. Of the estimated 15 million STDs that occur annually each year in the United States, 4 million are among adolescents and 6 million among young adults. The current epidemic is complicated by the high asymptomatic carrier state associated with most STDs and the inadequate protection of condoms in preventing transmission. Sexually active individuals, particularly adolescents, must be educated on the ramifications of early onset of sexual activity and the health consequences of multiple sexual partners.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Acceptance of altering the standard 21-day/7-day oral contraceptive regimen to delay menses and reduce hormone withdrawal symptoms.

OBJECTIVE: Measure acceptance and use of extending the number of active oral contraceptive (OC) pills beyond 21 days and/or shortening the hormone-free interval to reduce the frequency and severity of hormone withdrawal symptoms. STUDY DESIGN: A retrospective review was performed of patients on OCs with unwanted hormone withdrawal symptoms who were counseled by one osbtetrician-gynecologist (P. J. S.) on altering their standard 21/7 regimen. All patients used a monophasic 30 to 35 microg pill and underwent an initial counseling visit between December 1993 and October 2000. RESULTS: Of 318 patients counseled on "extending the number of active pills," 292 (92%) had documented follow-up after the initial counseling session. The primary reason for extending the number of active pills was to decrease symptoms of headache (35%), dysmenorrhea (21%), hypermenorrhea (19%), and premenstrual symptoms (13%). The remaining 12% of patients cited convenience, endometriosis, and other reasons such as menstrual-associated acne. Twenty-five (9%) of 292 chose not to extend, with a preference for monthly menses as the most common reason (40%) followed by a concern that symptoms were not severe enough to warrant extension (32%). Of 267 patients who initiated an extended regimen, 57 discontinued OCs, 38 returned to a standard regimen, and 172 were extending use at the time of last follow-up. Using survival analysis methods, at 5 years 46% +/- 5% (mean +/- SE) of patients continued an extended OC pattern. The regimen of OC use by patients continuing an extended pattern was 12 +/- 12 (mean +/- SD) weeks of active pills (median of 9 weeks and range to 104 weeks) with pill-free interval of 6 +/- 2 days (median of 5 days and range of 0-7 days). CONCLUSION: The majority of patients with hormone withdrawal symptoms on OCs will initiate a regimen of extending active pills, often with a shortened hormone-free interval to reduce frequency and severity of associated symptoms.

Adult↗