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1.
J Womens Health (Larchmt) ; 23(4): 310-7, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24450487

ABSTRACT

BACKGROUND: Migraine headaches are a significant problem for American women with many of them suffering from headaches around the time of their menstrual cycle. Women taking oral contraceptives in the standard 21/7 cycle regimen often suffer from headaches around the time of the hormone free intervals (HFIs) as well. Extended oral contraceptive regimens have been shown to decrease the frequency, but not eliminate these headaches. This study is a double-blind, randomized, placebo-controlled pilot study of participants with menstrual-related migraines (MRMs) who were initiated on extended combined oral contraceptives and given frovatriptan prophylactically during HFIs. METHODS: Participants having spontaneous menstrual cycles or taking daily combined oral contraceptives in a 21/7 regimen with MRMs were placed on a contraceptive containing levonorgestrel and ethinyl estradiol. Analyses compared headache scores during pre-study baseline cycles to those in a 168-day extended regimen with placebo versus frovatriptan treatments during HFIs. RESULTS: Daily headache scores decreased (p=0.034) from 1.29 ± 0.10 during pre-study cycles to 1.10 ± 0.14 during extended combined oral contraceptive use. Frovatriptan blocked the increase in headache score over the placebo during HFIs. However, following the withdrawal of frovatriptan, headache scores increased (p>0.01) despite resuming combined oral contraceptive use. CONCLUSIONS: Extended combined oral contraceptive regimen reduces MRM severity. Frovatriptan prevents headaches during HFIs, but is associated with new headache symptoms when withdrawn.


Subject(s)
Carbazoles/therapeutic use , Contraceptives, Oral, Combined/administration & dosage , Ethinyl Estradiol/administration & dosage , Levonorgestrel/administration & dosage , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Serotonin Receptor Agonists/therapeutic use , Tryptamines/therapeutic use , Adolescent , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Humans , Menstrual Cycle , Menstruation , Severity of Illness Index , Treatment Outcome , Young Adult
2.
Contraception ; 84(1): 71-5, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21664513

ABSTRACT

BACKGROUND: The survey was conducted to assess attitudes and patterns of health care providers (HCPs) prescribing extended regimen oral contraceptives (OCs). STUDY DESIGN: A prospective, anonymous, written survey that assessed attitudes and prescribed preferences of extended-cycle OCs was distributed at six educational conferences. RESULTS: An estimated 90% of the conference attendees participated in the survey. Of the 799 HCPs surveyed, 92% have recommended extended-cycle regimens with ob/gyn practitioners most likely to recommend their use (p<.05). The most commonly prescribed extended regimen remains an 84-day active pill cycle followed by a 7-day hormone-free interval (49%). The majority of HCPs (73.5%) continue to prescribe OCs which induce monthly withdrawal bleeds as their most common regimen. CONCLUSION: While HCPs appear to be recommending extended OC regimens more often, monthly cyclic regimens are the most commonly prescribed.


Subject(s)
Attitude of Health Personnel , Contraceptives, Oral/administration & dosage , Practice Patterns, Physicians'/statistics & numerical data , Female , Humans , Male , Menstruation , Prospective Studies
3.
Obstet Gynecol ; 112(3): 563-71, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18757653

ABSTRACT

OBJECTIVE: To assess bleeding patterns with continuous use of the transvaginal contraceptive ring. METHODS: We did a prospective analysis of daily menstrual flow during a 21/7 cycle followed by 6 months of continuous use and institution of a randomized protocol to manage breakthrough bleeding/spotting. Seventy-four women completed the baseline 21/7 phase and were randomized equally into two groups during the continuous phase. Group 1 was instructed to replace the ring monthly on the same calendar day with no ring-free days. Group 2 was instructed to use the same process, but if breakthrough bleeding/spotting occurred for 5 days or more, they were to remove the ring for 4 days, store it, and then reinsert that ring. RESULTS: Sixty-five women completed the continuous phase with reduced average flow scores in the continuous phase compared with the 21/7 phase (P<.02). Most patients had no to minimal bleeding during continuous use, with group 2 experiencing a statistically greater percentage of days without breakthrough bleeding or spotting (95%) compared with group 1 (89%) (P=.016). Instituting a 4-day hormone-free interval was more (P<.001) effective in resolving breakthrough bleeding/spotting than continuing ring use. CONCLUSION: A reduction in bleeding occurred during continuous use with replacement of the transvaginal ring compared with baseline 21/7 use. Continuous vaginal ring use resulted in an acceptable bleeding profile in most patients, reduction in flow, reduction in pelvic pain, and a high continuation rate.


Subject(s)
Contraceptive Agents, Female/adverse effects , Contraceptive Devices, Female/adverse effects , Metrorrhagia/chemically induced , Progestins/adverse effects , Adult , Contraceptive Agents, Female/administration & dosage , Desogestrel/administration & dosage , Desogestrel/adverse effects , Desogestrel/analogs & derivatives , Drug Administration Schedule , Drug Combinations , Ethinyl Estradiol/administration & dosage , Ethinyl Estradiol/adverse effects , Female , Humans , Progestins/administration & dosage
4.
Pharmacotherapy ; 28(5): 576-83, 2008 May.
Article in English | MEDLINE | ID: mdl-18447656

ABSTRACT

STUDY OBJECTIVE: To compare two scales used in research to evaluate daily premenstrual mood symptoms during use of a monophasic oral contraceptive. DESIGN: Subanalysis of data from a prospective study. SETTING: University-affiliated medical center. SUBJECTS; One hundred two reproductive-aged (18-48 yrs) women taking a monophasic oral contraceptive containing ethinyl estradiol and drospirenone in the standard 21-7 fashion (21 days of hormones followed by 7 days of placebo), and who had self-identified premenstrual symptoms of headache, mood changes, or pelvic pain. INTERVENTION: Subjects completed a single-item questionnaire, the Scott & White Daily Diary of Symptoms, and a multiple-item questionnaire, the Penn State Daily Symptom Report (DSR), to assess their premenstrual symptoms. The Scott & White diary used a visual analog scale of 0-10 to assess pelvic pain, headache, and mood (a composite of anxiety, depression, and irritability). The Penn State DSR contained 17 items: 10 behavioral and seven physical components, each rated on a scale of 0-4, with one item that specifically rated mood swings. MEASUREMENTS AND MAIN RESULTS: Scores from the two scales were compared by using Spearman correlation coefficients, the Kendall W for concordance, and linear regression of ranked sums for study cycles. The Scott & White mood score significantly correlated with the total of the 17 items on the Penn State DSR, as well as the 10 behavioral items, the seven physical items, and the single mood-swing item (p<0.0001); specific coefficients of concordance were 0.44, 0.23, 0.10, and 0.28, respectively, and R2 values were 0.39, 0.39, 0.30, and 0.34, respectively. The daily Scott & White mood score was positively correlated with all 17 elements of the Penn State DSR (0.25-0.57). The greatest correlation was seen with the mood-swing element. Both instruments demonstrated the same patterns during the 21-7 oral contraceptive cycle, with symptoms increasing immediately before and peaking during the 7-day hormone-free interval. CONCLUSION: A single-item daily mood score using a rating scale of 0-10 was concordant with a relatively complex 17-element symptom index and demonstrated the same pattern of change during cycles of oral contraception. The simple scoring system offers an advantage, especially in clinical studies of long duration.


Subject(s)
Affect/drug effects , Contraceptives, Oral, Combined/therapeutic use , Contraceptives, Oral, Hormonal/therapeutic use , Premenstrual Syndrome/diagnosis , Surveys and Questionnaires , Weights and Measures , Adolescent , Adult , Androstenes/therapeutic use , Drug Combinations , Estrogens/therapeutic use , Ethinyl Estradiol/therapeutic use , Female , Humans , Middle Aged , Mineralocorticoid Receptor Antagonists/therapeutic use
5.
Obstet Gynecol Clin North Am ; 35(2): 185-97, vii, 2008 Jun.
Article in English | MEDLINE | ID: mdl-18486836

ABSTRACT

Women have many options regarding contraception. A patient's desire for a long- or short-term method, for one that is reversible or permanent, and her belief that she can be compliant with the method all factor into the choice of contraceptive method. Practitioners must discuss coexisting conditions, contraindications, and whether the patient desires scheduled monthly bleeding or if she will tolerate unscheduled bleeding. Finally, cost and coverage by insurance tends to be one of the most important factors in choosing the method of contraception.


Subject(s)
Contraception/adverse effects , Contraception/methods , Contraceptive Agents/administration & dosage , Female , Hormones/administration & dosage , Humans
6.
J Reprod Med ; 53(4): 266-70, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18472649

ABSTRACT

OBJECTIVE: To compare hormone levels and symptoms during transition from standard to extended oral contraceptive (OC) regimens. STUDY DESIGN: A prospective analysis of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and inhibin-B levels with symptoms during 21/7-day vs. 168/7-day extended OCs containing 3 mg of drosperinone and 30 mcg of ethinyl estradiol. Blood samples were obtained from 10 subjects in each of 4 weeks in the 21/7 regimen, in the first 6 weeks of the extended regimen, and again the week before, the week of and the week after the 7-day hormone-free interval (HFI) at the end of the extended regimen. RESULTS: All 4 hormones followed a cyclic pattern with decreasing levels during the 3 active pill weeks of the 21/7 cycle, followed by an increase during the 7-day HFI, which continued into the extended regimen. Levels then decreased during the extended regimen and remained low at week 24. During the 7-day HFI after the extended regimen FSH and LH again increased above baseline (p > 0.07). Hormone withdrawal symptoms increased at the end of 21 active pills with increasing severity during the 7-day HFI. CONCLUSION: Absence of pituitary and ovarian suppression associated with HFI leads to fluctuations in hormones and associated hormone withdrawal symptoms.


Subject(s)
Contraceptives, Oral/administration & dosage , Estradiol/blood , Follicle Stimulating Hormone/blood , Inhibins/blood , Luteinizing Hormone/blood , Adult , Androstenes/administration & dosage , Cohort Studies , Drug Administration Schedule , Estrogens/administration & dosage , Ethinyl Estradiol/administration & dosage , Female , Humans , Middle Aged , Mineralocorticoid Receptor Antagonists/administration & dosage , Prospective Studies
8.
Contraception ; 77(3): 162-70, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18279685

ABSTRACT

BACKGROUND: The study was conducted to evaluate follicular development and hormone patterns with three oral contraceptive (OC) regimens before, during and after the 7-day hormone-free interval (HFI) or 7-day ethinyl estradiol (EE)-supplemented interval. STUDY DESIGN: The study is a single-center, open-label, prospective, randomized trial to evaluate pituitary-ovarian suppression with three OC regimens containing identical hormones: 30 mcg of EE and 150 mcg of levonorgestrel (LNG). METHODS: After a standard 21/7 OC baseline cycle, subjects were randomized to one of three treatment groups: (1) three 21/7-day cycles of 150 mcg LNG/30 mcg EE for 21 days followed by 7 days of placebo (n=10); (2) one 84/7-day cycle of 150 mcg LNG/30 mcg EE for 84 days followed by 7 days of placebo (n=12) and (3) one 84/7EE-day cycle of 150 mcg LNG/30 mcg EE for 84 days followed by 7 days of 10 mcg EE (n=11). Estradiol; follicle-stimulating hormone (FSH); luteinizing hormone and inhibin-B levels, ovarian follicles and daily symptom diaries were collected. RESULTS: Compared to subjects receiving placebo during the 7-day HFI, those receiving EE demonstrated reductions (p<.05) in both FSH and estradiol. Number of developing follicles was less after the 7-day EE interval compared to that after 7-day HFI. Subjects on the 84/7 and 84/7EE regimens reported less (p=.03) daily menstrual flow than those on the 21/7-day regimen. A trend (p=.06) toward reduced headaches during the 7-day EE-supplemented interval was noted. CONCLUSIONS: Supplementation of the standard 7-day HFI with 10 mcg EE after 84 days of an extended OC decreased FSH levels and decreased the number of developing follicles.


Subject(s)
Contraceptives, Oral, Combined/administration & dosage , Ethinyl Estradiol/administration & dosage , Levonorgestrel/administration & dosage , Ovarian Follicle/drug effects , Pituitary Gland/drug effects , Adult , Contraceptives, Oral, Synthetic/administration & dosage , Drug Administration Schedule , Estradiol/blood , Female , Follicle Stimulating Hormone/blood , Humans , Inhibins/blood , Luteinizing Hormone/blood , Ovarian Follicle/diagnostic imaging , Ovarian Follicle/physiology , Pituitary Gland/physiology , Prospective Studies , Ultrasonography
9.
Best Pract Res Clin Obstet Gynaecol ; 22(2): 355-74, 2008 Apr.
Article in English | MEDLINE | ID: mdl-17892973

ABSTRACT

Oral contraceptives (OCs) remain the most common method of reversible contraception. Despite lowering of oestrogen and progestin content, the same basic design of 21 combination oestrogen plus progestin pills followed by a week of placebo pills has remained. Numerous studies have now documented that the 21/7 regimen needs to be modified. The 7-day hormone-free interval (HFI) in today's low-dose OCs is associated with reduced pituitary-ovarian suppression, allowing for ovarian follicular development, endogenous oestradiol production and possible ovarian cyst formation and ovulation. The 7-day HFI is also associated with hormone withdrawal symptoms that can lead to discontinuation and unintended pregnancy. Modifications in OC regimens are now appearing on the market secondary to the accumulated scientific data on the disadvantages of low-dose 21/7 pills. This article will review the data on problems with standard OC regimens and modifications that can improve the efficacy and side-effect profile.


Subject(s)
Contraception/trends , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Hormonal/administration & dosage , Chemistry, Pharmaceutical , Contraceptives, Oral, Combined/adverse effects , Contraceptives, Oral, Combined/pharmacology , Contraceptives, Oral, Hormonal/adverse effects , Contraceptives, Oral, Hormonal/pharmacology , Drug Administration Schedule , Female , Humans , Menstruation/drug effects , Menstruation Disturbances/prevention & control , Ovary/drug effects , Pituitary Gland/drug effects , Substance Withdrawal Syndrome
10.
Contraception ; 75(6): 444-9, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17519150

ABSTRACT

OBJECTIVE: The study was conducted to assess hormone withdrawal symptoms, patient acceptance and occurrence and management of bleeding with an extended oral contraceptive (OC) regimen. METHODS: Subjects were placed on an OC containing 3 mg drosperinone (DRSP) and 30 microg ethinyl estradiol (EE), in the standard 21/7 fashion for two cycles, before converting to an extended pattern of OC for women who indicated they had menstrually related symptoms such as headaches, cramping and mood swings (52 weeks with phone-call follow-up 6 months later). Daily assessments of bleeding, headache, pelvic pain, mood and number of pain pills were recorded. Results are reported as means with S.E., and values were compared using analysis of variance with Dunnett's post hoc test for comparison with 21/7 cycle, Duncan's post hoc test for comparison of changes during the course of the extended regimen and Pearson's chi-square for comparison of proportions. RESULTS: Of the 111 women who began the extended OC regimen, 80 completed 1 year of use. Mood scores, headache scores and pelvic pain were all improved in the extended OC intervals, compared to the 21/7 cycle (p<.001 for all comparisons). Improvement in symptoms persisted throughout the 1 year extended regimen. The findings indicated that 53.7% of subjects had no breakthrough bleeding or breakthrough spotting (BTB/BTS) during any given 28-day interval of the extended regimen. BTB/BTS decreased in the second half compared to the first half of the extended regimen. To manage BTB/BTS, instituting a 3-day hormone-free interval (HFI) was significantly more effective than continuing OCs (p<.001). At the 6-month follow-up, most subjects had continued the extended regimen on their own with a high level of satisfaction. CONCLUSIONS: An extended OC regimen containing DRSP/EE significantly improved mood, headaches and pelvic pain scores throughout the 1 year of use, compared to a 21/7 cycle. Sustained BTB/BTS episodes occurred in 45 subjects (56%), decreasing in the second half of the study and effectively managed with a 3-day HFI.


Subject(s)
Contraceptives, Oral, Combined/administration & dosage , Menstruation/drug effects , Patient Satisfaction , Affect/drug effects , Androstenes/administration & dosage , Contraceptives, Oral, Combined/adverse effects , Drug Administration Schedule , Ethinyl Estradiol/administration & dosage , Female , Headache , Humans , Pelvic Pain/drug therapy , Prospective Studies , Texas , Treatment Outcome
11.
Contraception ; 74(2): 100-3, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16860046

ABSTRACT

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.


Subject(s)
Contraceptives, Oral/administration & dosage , Ovary/physiology , Pituitary Gland/physiology , Adult , Estradiol/blood , Female , Follicle Stimulating Hormone/blood , Humans , Inhibins/blood , Luteinizing Hormone/blood , Ovary/drug effects , Pituitary Gland/drug effects , Prospective Studies
12.
Am J Obstet Gynecol ; 195(1): 78-84, 2006 Jul.
Article in English | MEDLINE | ID: mdl-16813746

ABSTRACT

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.


Subject(s)
Health Knowledge, Attitudes, Practice , Sex Education , Academic Medical Centers , Adolescent , Child , Female , Humans , Logistic Models , Male , Odds Ratio , Pregnancy , Pregnancy in Adolescence/prevention & control , Risk Reduction Behavior , Sexual Behavior/statistics & numerical data , Socioeconomic Factors , Texas
13.
Am J Obstet Gynecol ; 195(5): 1311-9, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16796986

ABSTRACT

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.


Subject(s)
Androstenes/administration & dosage , Contraceptives, Oral, Combined/administration & dosage , Estrogens/administration & dosage , Ethinyl Estradiol/administration & dosage , Mineralocorticoid Receptor Antagonists/administration & dosage , Premenstrual Syndrome/drug therapy , Adult , Affect , Androstenes/therapeutic use , Contraceptives, Oral, Combined/therapeutic use , Drug Administration Schedule , Estrogens/therapeutic use , Ethinyl Estradiol/therapeutic use , Female , Humans , Middle Aged , Mineralocorticoid Receptor Antagonists/therapeutic use , Premenstrual Syndrome/physiopathology , Premenstrual Syndrome/psychology , Prospective Studies , Severity of Illness Index , Treatment Outcome
14.
Am J Obstet Gynecol ; 195(4): 935-41, 2006 Oct.
Article in English | MEDLINE | ID: mdl-16647684

ABSTRACT

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.


Subject(s)
Contraceptives, Oral, Combined/administration & dosage , Menstruation/drug effects , Adolescent , Adult , Androstenes/administration & dosage , Drug Administration Schedule , Ethinyl Estradiol/administration & dosage , Female , Humans , Middle Aged , Prospective Studies
15.
Contraception ; 73(1): 34-40, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16371292

ABSTRACT

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.


Subject(s)
Androstenes/administration & dosage , Contraceptives, Oral/administration & dosage , Ethinyl Estradiol/administration & dosage , Adult , Contraceptives, Oral/adverse effects , Female , Humans , Menstrual Cycle , Patient Satisfaction , Prospective Studies , Time Factors , Uterine Hemorrhage/epidemiology
16.
Contraception ; 73(1): 41-5, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16371293

ABSTRACT

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.


Subject(s)
Attitude of Health Personnel , Contraceptives, Oral/administration & dosage , Menstrual Cycle , Practice Patterns, Physicians' , Female , Gynecology , Humans , Nurse Practitioners , Obstetrics , Physicians, Family , Surveys and Questionnaires , Time Factors
17.
Am J Manag Care ; 11(16 Suppl): S492-7, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16336058

ABSTRACT

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.


Subject(s)
Contraceptives, Oral, Hormonal/therapeutic use , Ovulation Inhibition/drug effects , Premenstrual Syndrome/physiopathology , Adolescent , Adult , Female , Humans , Middle Aged
18.
Am J Obstet Gynecol ; 193(6): 1945-54, 2005 Dec.
Article in English | MEDLINE | ID: mdl-16325595

ABSTRACT

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.


Subject(s)
Adolescent Behavior , Health Knowledge, Attitudes, Practice , Sex Education , Sexual Behavior , Adolescent , Adult , Female , Humans , Male
20.
Contraception ; 70(4): 281-7, 2004 Oct.
Article in English | MEDLINE | ID: mdl-15451331

ABSTRACT

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.


Subject(s)
Contraceptives, Oral/administration & dosage , Contraceptives, Oral/adverse effects , Uterine Hemorrhage/prevention & control , Adolescent , Adult , Dysmenorrhea/drug therapy , Dysmenorrhea/epidemiology , Female , Humans , Hypertension/epidemiology , Middle Aged , Pelvic Pain/drug therapy , Pelvic Pain/epidemiology , Premenstrual Syndrome/drug therapy , Premenstrual Syndrome/epidemiology , Quality of Life , Retrospective Studies , Thrombophlebitis/epidemiology
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