Biomedical subjects

Jeffrey T Jensen

Publications and source records attributed to Jeffrey T Jensen.

18 recordsLinked to original sources

PubMed2006

Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results.

OBJECTIVE: This study was conducted to evaluate the safety and efficacy of a continuous daily regimen of levonorgestrel (LNG) 90 microg/ethinyl estradiol (EE) 20 microg (continuous LNG/EE). METHODS: Healthy women aged 18-49 years with regular menstrual cycles for 3 months enrolled in this single-treatment open-label study and took one pill of LNG 90 microg/EE 20 microg daily for 12 months. RESULTS: For the 2134 subjects enrolled, the Pearl Index method failure was 1.26, and user failure was 0.34. While on Pill Pack 13, 58.7% of subjects reported amenorrhea and 79.0% reported absence of bleeding. Overall, the number of bleeding and spotting days per pill pack declined progressively. Adverse events and discontinuations were comparable to those reported for cyclic oral contraceptive (OC) regimens, except for higher rates in those related to uterine bleeding. CONCLUSIONS: Continuous LNG/EE demonstrated a good safety profile and efficacy similar to cyclic OCs. The regimen continuously inhibited menses, increased the incidence of amenorrhea over time and, except for a subset of women, decreased the number of bleeding and spotting days.

Adolescent↗

PubMed2006

Cervical preparation using laminaria with adjunctive buccal misoprostol before second-trimester dilation and evacuation procedures: a randomized clinical trial.

OBJECTIVE: This study was undertaken to determine whether buccal misoprostol improves cervical preparation achieved with laminaria before second-trimester dilation and evacuation procedures. STUDY DESIGN: A randomized, double blind, placebo-controlled trial of preoperative cervical preparation with overnight laminaria and either buccal placebo or 400 microg buccal misoprostol approximately 90 minutes before second-trimester surgical abortion. Block randomization was used to provide balanced enrollment into 2 separate gestational age study groups: early (13-15(6/7)) and mid (16-20(6/7)) second trimester. Surgeons tested maximal cervical dilation by inserting the largest dilator that could be passed through the cervical os without force. Subject demographics and preprocedure symptoms were tracked. RESULTS: Groups were similar in regard to age, gravity, parity, delivery type, and gestational age. Data were analyzed from 125 women in the 13 to 15(6/7) (30 misoprostol, 32 placebo) and 16 to 20(6/7) (31 misoprostol, 32 placebo) gestational age groups. Overall, misoprostol treatment did not improve the initial mean dilation achieved with laminaria alone in either the 13 to 15(6/7) (46.0 fr +/- 5.0; placebo 45.0 fr +/- 6.2, P = .68) or 16 to 20(6/7) (50.9 fr +/- 5.6, placebo 48.9 fr +/- 5.2, P = .16) groups. However, a subanalysis of gestations 19 weeks or more demonstrated significantly greater dilation in the misoprostol group (53.6 fr fr +/- 5.3, placebo 48.5 fr +/- 5.0, P = .01). Subjects receiving misoprostol reported significantly more cramping than those receiving placebo (13-15(6/7) weeks misoprostol 25/30, 83%; placebo 17/32, 53%, P = .02; 16-20(6/7) week misoprostol 25/31, 81%, placebo 16/32, 50%, P = .02). CONCLUSION: Cervical dilation with laminaria is augmented by 400 microg buccal misoprostol in gestations 19 weeks or more, but not in earlier gestations. Misoprostol causes more abdominal cramping.

Abortifacient Agents, Nonsteroidal↗

PubMed2006

Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions.

OBJECTIVE: To study the effects of a 4% intrauterine lidocaine infusion on perceived patient pain in first-trimester abortions. METHODS: A randomized, double-blind, placebo-controlled trial of 80 women receiving either a 5-mL 4% lidocaine (n = 40) or saline (n = 40) intrauterine infusion and a standard paracervical block before first-trimester abortion. Women completed a series of 100-mm visual analog scales (anchors: 0 = none, 100 mm = worst imaginable) to measure their perceived pain (anticipated pain, after speculum insertion, after intrauterine infusion, after cervical dilation, after suction aspiration, and 30 minutes postprocedure). Eight women volunteered for serum lidocaine levels after the lidocaine infusion. RESULTS: Groups were similar in respect to age, parity, prior abortion, ethnicity, gestational age, and level of dysmenorrhea. Pain scores demonstrated a significant difference between groups during cervical dilation (saline 55 mm +/- 26, lidocaine 35 mm +/- 30, P < .01) and during aspiration (saline 71 mm +/- 20, lidocaine 43 mm +/- 30, P < .01). The lidocaine group reported significantly more symptoms (ie, oral numbness and tingling) than the saline group (saline 0/39, lidocaine 16/38, 42%, P < .01). The highest serum lidocaine level recorded was 4.0 microg/mL (lidocaine group). There was no difference in overall satisfaction between the 2 groups. CONCLUSION: Compared with paracervical block alone, the addition of a 4% intrauterine lidocaine infusion resulted in a significant reduction in patient perception of pain during first-trimester abortion. Although subjective symptoms of systemic lidocaine effect were common, no subjects demonstrated serum levels consistent with lidocaine toxicity. However, further studies to determine safety are needed. LEVEL OF EVIDENCE: I.

Abortion, Induced↗

PubMed2006

Continuous oral contraceptives: are bleeding patterns dependent on the hormones given?

OBJECTIVE: To estimate whether progestin type or estrogen dose influences bleeding patterns, adverse effects, or satisfaction with combined oral contraceptives dosed continuously. METHODS: This was a randomized, double blind, 4-arm active treatment study. Subjects received either 100 microg levonorgestrel/20 microg ethinyl estradiol (E2) (20LNG group), 100 microg levonorgestrel/30 microg ethinyl E2 (30LNG group), 1,000 microg norethindrone acetate/20 microg ethinyl E2 (20NETA group), or 1,000 microg norethindrone acetate/30 microg ethinyl E2 (30NETA group) for 180 days. Subjects logged bleeding events and adverse effects on a daily menstrual calendar. An exit survey measured satisfaction with bleeding patterns. RESULTS: One hundred thirty-nine women were enrolled. Patients in the 20NETA and 30NETA arms had significantly more days of amenorrhea than the 30LNG arm in the second 90 days (P < .008). The 30LNG group reported more spotting days than the 20NETA group over the entire study period (P < .008) and the 30NETA group for the second 90 days (P < .008). Only a small number of bleeding days were reported with no differences between groups. No differences in adverse effects between groups were found. Women in the 30LNG arm reported lower levels of satisfaction with their bleeding patterns than the other groups (30LNG compared with 20NETA, P = .01; 30LNG compared with 30NETA, P = .001). CONCLUSION: The addition of 10 microg of ethinyl E2 to a 20 microg ethinyl E2 pill containing levonorgestrel or norethindrone acetate did not improve bleeding patterns. During continuous dosing, the use of oral contraceptives containing 1,000 microg norethindrone acetate resulted in more days of amenorrhea and fewer days of spotting than preparations containing 100 microg levonorgestrel. LEVEL OF EVIDENCE: I.

Adult↗

PubMed2005

Comparison of perinatal grief after dilation and evacuation or labor induction in second trimester terminations for fetal anomalies.

OBJECTIVE: This study was undertaken to compare grief resolution after dilation and evacuation (D&E) or induction of labor (IOL) for second-trimester pregnancy termination. STUDY DESIGN: A prospective cohort of 49 women choosing second-trimester abortion caused by fetal anomalies by either medical IOL or D&E. Depression was evaluated by using the Edinburgh Postnatal Depression Scale and bereavement was assessed by using the Perinatal Grief Scale with follow-up to 12 months after pregnancy termination. Data were analyzed with chi 2 tests, Mann-Whitney U tests, and independent and paired sample t tests. RESULTS: There was no significant difference in depression incidence on enrollment (61.9% D&E, 53.8% IOL, P = .579), at 4 months (23.5% D&E, 14.3% IOL, P = .252) or 12 months (27.3% D&E, 20.0% IOL, P = .696) or on the PGS at 4 months (74.1 vs 90.2, P = .351) or 12 months (73.3 vs 86.4, P = .658). CONCLUSION: There is no significant difference in grief resolution among women who terminate a desired pregnancy by either medical or surgical abortion.

Abnormalities, Multiple↗

PubMed2005

The phosphodiesterase 3 inhibitor ORG 9935 inhibits oocyte maturation during gonadotropin-stimulated ovarian cycles in rhesus macaques.

To determine whether phosphodiesterase (PDE) 3 inhibitors prevent the resumption of meiosis by primate oocytes in vivo, rhesus macaques were stimulated to develop multiple preovulatory follicles by administering human recombinant gonadotropins, and follicles were aspirated 34 h after an ovulatory stimulus (human chorionic gonadotropin [hCG]). Monkeys received no further treatment (controls) or the PDE3 inhibitor ORG 9935 (a) exclusively in the periovulatory interval beginning 6-12 h prior to receiving hCG at 200 mg/kg every 12 h orally (PER200) or a 200 mg/kg oral loading dose followed by 50 mg/kg sc every 6 h (PER50) or (b) throughout the ovarian stimulation protocol with daily increases until a dose of 200 mg/kg bid was administered onward from the eighth day of ovarian stimulation (EXT200). The primary outcome was the number of oocytes that had resumed meiosis (germinal vesicle breakdown [GVBD]) at collection. At initial aspiration, 85% of oocytes recovered from control animals (n = 4) had progressed to GVBD compared with 53% (p<.01), 23% (p<.01), and 13% (p<.01) recovered from animals in the PER200 (n = 2), PER50 (n = 1) and EXT200 (n = 3) groups, respectively. Although spontaneous maturation of oocytes was observed during follow-up culture in the absence of ORG 9935, none of the oocytes in the PER50 or EXT200 underwent normal fertilization in vitro. These results demonstrate that the PDE3 inhibitor ORG 9935 blocks oocyte maturation during gonadotropin-stimulated ovarian cycles in rhesus macaques and suggest that PDE3 inhibitors have potential clinical use as contraceptives in women.

3',5'-Cyclic-AMP Phosphodiesterases↗

PubMed2005

Contraceptive and therapeutic effects of the levonorgestrel intrauterine system: an overview.

UNLABELLED: The levonorgestrel intrauterine system (LNG IUS), a steroid-releasing intrauterine system, is a T-shaped device that releases levonorgestrel directly into the uterine cavity at an initial rate of 20 mug per day. The contraceptive and therapeutic benefits of the LNG IUS stem primarily from its local effects. The local hormone delivery causes high levonorgestrel levels in the endometrial tissue but low levels in the systemic circulation. This leads to strong endometrial suppression and, in many cases, a dramatic reduction in menstrual blood loss. The high contraceptive efficacy is well documented through extensive international clinical research. This review article provides an overview of the LNG IUS and addresses the following topics: mechanisms of action, contraceptive efficacy, changes in bleeding patterns, principal safety issues, potential noncontraceptive benefits, and implications for women's reproductive health. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to explain that the levonorgestrel intrauterine system (LNG IUS) has contraceptive and therapeutic benefits, identify the main site of action as the endometrium, and to recall that the safety of the system has been validated over time.

Contraception↗

PubMed2004

Patient satisfaction after the treatment of vulvovaginal erosive lichen planus with topical clobetasol and tacrolimus: a survey study.

OBJECTIVE: The purpose of this study was to compare patient satisfaction with the topical immune system modulator tacrolimus to topical clobetasol during treatment for vulvovaginal erosive lichen planus. STUDY DESIGN: Subjects who had been diagnosed with vulvovaginal erosive lichen planus between June 2000 and May 2001 received a mail survey regarding clinical satisfaction and response to treatment with clobetasol and tacrolimus. Satisfaction was assessed with a 100-mm visual analogue scale (very unsatisfied, 0; very satisfied, 100). Satisfaction was compared with the use of a paired t-test. RESULTS: Nineteen subjects met the inclusion criteria; 17 subjects (89%) returned completed surveys. Sixteen of the 17 women reported clobetasol therapy, and 11 of the 17 subjects acknowledged the use of tacrolimus therapy. All but 1 of the women who received tacrolimus had been treated previously with clobetasol therapy. All subjects reported experiencing sexual pain before their initial examination. After treatment with clobetasol, 2 of 16 women reported pain-free intercourse. Two additional women reported pain-free intercourse after switching to tacrolimus therapy. Ten subjects who had used both treatments rated tacrolimus therapy as significantly more satisfactory than clobetasol therapy (63 vs 38 mm; P=.03). CONCLUSION: The use of topical tacrolimus improves satisfaction and may result in better clinical outcomes than therapy with clobetasol for the treatment of vulvovaginal erosive lichen planus.

Administration, Topical↗

PubMed2004

Teaching contraception: an interactive presentation using managing contraception.

OBJECTIVE: Our purpose was to determine whether an interactive medical student contraceptive teaching session results in improved knowledge gain or satisfaction when compared with a standard, didactic lecture. STUDY DESIGN: An interactive lecture was compared with a standard lecture among third-year medical students at Oregon Health and Science University School of Medicine and Medical College of Georgia. Knowledge gain was assessed by comparing correct responses to a posttest with the students' own responses to the same questions given as a pretest before the lecture. Satisfaction with the lecture was assessed on a visual analog scale. Scores and satisfaction ratings were compared within and between lecture groups. RESULTS: A total of 150 students participated. There was a significant increase in test scores within both the interactive and standard groups ( P < .0001 for both groups). The change in scores did not differ significantly between the groups ( P = .087). Although overall satisfaction was significantly greater with the standard lecture ( P = .004), it was high with both lectures. CONCLUSION: Knowledge gain with the interactive lecture was equivalent to that with the standard lecture. Satisfaction with both learning formats was high.

Adult↗

PubMed2004

Intrauterine lidocaine infusion for pain management in first-trimester abortions.

OBJECTIVE: To study the effects of an intrauterine lidocaine infusion on perceived patient pain in first-trimester abortions and to measure serum lidocaine levels. METHODS: A randomized, double-blind, placebo control trial of 80 women receiving either a 10-mL 1% lidocaine (n = 40) or saline (n = 40) intrauterine infusion and a standard paracervical block before first-trimester abortion was undertaken. Women completed a series of 100-mm visual analogue scales to measure their perceived pain (anticipated pain, after speculum insertion, after intrauterine infusion, after cervical dilation, after suction aspiration, and 30 minutes after procedure). Twenty women (10 in each group) volunteered for serum lidocaine levels at 10, 20, 30, 45, and 60 minutes after the lidocaine infusion. RESULTS: Groups were similar in respect to age, parity, prior abortion, ethnicity, gestational age, level of dysmenorrhea, and complications. Pain scores by visual analogue scale demonstrated no significant difference between groups at any time point during the procedure; in particular, pain during aspiration (saline infusion 51 +/- 26 mm, lidocaine infusion 47 +/- 28 mm; P =.51). Peak serum levels occurred at approximately 10 minutes after lidocaine infusion. The highest level recorded (lidocaine group) was 2.5 microg/mL (toxicity more than 5 microg/mL). CONCLUSION: Compared with paracervical block alone, the addition of a 1% intrauterine lidocaine infusion resulted in no improvement in patient perception of pain during first-trimester abortion. No subjects demonstrated symptoms or serum levels of lidocaine toxicity. LEVEL OF EVIDENCE: I

Abortion, Induced↗

PubMed2003

Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose oral contraceptive: a randomized trial.

The purpose of this study is to compare bleeding patterns and acceptability of a contraceptive regimen of combined 20 microg ethinyl estradiol/100 microg levonorgestrel taken with and without a hormone-free interval. Thirty-two women desiring oral contraception were randomized to six 28-day cycles (standard group) or 168 days without a pill-free interval (continuous group). Participants kept a daily bleeding calendar documenting bleeding events (none, spotting or required sanitary protection) and side effects (headache, nausea, breast tenderness, depression, premenstrual syndrome and bloating). Primary outcome was number of bleeding days. Secondary outcomes included bleeding days requiring sanitary protection, amenorrhea, patient acceptability of bleeding patterns, method satisfaction and affective side effects. There were no differences in the baseline characteristics of the two groups. Although total bleeding days were fewer in the continuous group (mean = 25.9 vs. 34.9 days), this result did not reach statistical significance. However, women in the continuous group reported significantly fewer bleeding days that required protection (18.4 vs. 33.8 days, p < 0.01), and were more likely to have amenorrhea. Although both groups reported a high level of satisfaction with bleeding patterns and side effect profiles, women in the continuous group reported significantly fewer days of bloating (0.7 vs. 11.1 days, p = 0.04), and menstrual pain (1.9 vs. 13.3 days, p < 0.01). Continuous use of 20 microg ethinyl estradiol/100 microg levonorgestrel is associated with less bleeding requiring protection, and more amenorrhea than standard administration. Taken with or without a hormone-free interval, this oral contraceptive formulation is highly acceptable with regard to bleeding patterns and side effect profile. The continuous group had fewer light and moderate bleeding days, less bloating and menstrual pain. For patients who are seeking these results, this method may be more desirable.

Adult↗

PubMed2003

Quality of life and sexual function after evaluation and treatment at a referral center for vulvovaginal disorders.

OBJECTIVES: This study was undertaken to assess sexual function and quality of life of women after evaluation and treatment of vulvovaginal problems at a University Center. STUDY DESIGN: Subjects were mailed a cover letter and follow-up survey. All new patients (322) referred for evaluation of vulvar problems at a University Vulvar Specialty Clinic between January 1, 1996, and December 31, 1999, were mailed a survey instrument containing specific questions concerning general, vulvar, and sexual health. Medical records from clinic visits were manually abstracted. Groups defined with descriptive statistics and proportional change in symptoms analyzed with chi(2) statistics. RESULTS: Of the 322 women who met the study criteria, 195 returned valid surveys for an overall response rate of 60.5%. The mean duration of follow-up was 28 months. The most common presenting symptoms were vulvar pain (86%), dyspareunia (71%), itching (35%), and skin changes (20%). At follow-up, 128 (66%) reported improvement in symptoms compared with 14 (7%) that worsened (P <.001). Although subjects did not report an increase in the frequency of sexual activity, significantly more women reported an increase in enjoyment (n = 77, 43%) of sexual activity than a decrease (n = 30, 17%, P <.001). CONCLUSION: Most women presenting for evaluation of vulvar pain will report improvement in symptoms and sexual function after treatment in a Vulvar Specialty Clinic.

Adolescent↗

PubMed2003

Successful medical abortion of a pregnancy within a noncommunicating rudimentary uterine horn.

In asymptomatic patients with an early gestation located in a noncommunicating rudimentary horn, methotrexate may provide another treatment option or act as a useful adjunct to surgical intervention. We present a case of a successful pregnancy termination of a gestation located in a noncommunicating rudimentary horn with subsequent elective laparoscopic resection.

Abortifacient Agents, Nonsteroidal↗

PubMed2003

Women's knowledge and sources of information on the risks and benefits of oral contraception.

OBJECTIVE: To assess the knowledge of the risks and benefits of oral contraceptives (OCs) in a heterogeneous group of women and to identify their sources of information. METHODS: A self-administered questionnaire assessing demographics, contraception history, knowledge of risks and benefits of OCs, and information sources was given to literate English- and Spanish-speaking women waiting for appointments at 4 clinics serving distinct populations in Portland, Oregon. RESULTS: Approximately half of the 211 women studied were of the opinion that OCs decreased the risk of acne, dysmenorrhea, and menorrhagia and increased the risk of weight gain, headaches, and thrombosis. Less than 15% knew of the decreased risk of anemia, endometrial cancer, colon cancer and pelvic inflammatory disease, but 28% understood the decreased risk of ovarian cancer. Seven percent to 36% of women used their own experiences in assessing the effect of OCs on a variety of general and reproductive factors. Women relied primarily on printed information for knowledge of OCs' effects on cardiovascular health and cancer. CONCLUSION: Women in this heterogeneous population of women were unaware of several benefits of OCs. Women relied heavily on their own experiences in assessing the risks and benefits of OCs. Women cited printed information more frequently than medical personnel as major sources of information on cardiovascular and oncological risks and benefits of OCs. The Internet, however, played a minimal, if any role in educating women about OCs.

Adolescent↗

PubMed2002

Male contraception.

From a public health perspective, the need for contraception has never been greater. Although the existing male-specific methods (withdrawal, condoms, and vasectomy) are safe and effective, increasing male options for fertility control could improve family planning. For new male contraceptive methods to have an impact, they must be acceptable to both men and women, as well as effective. A male hormonal method will likely come to market within the next 5 years. Other strategies such as contraceptive vaccines, and inhibitors of spermatogenesis and sperm motility, provide a potential for nonhormonal male contraceptives.

Animals↗

PubMed2002

Comparing bimanual pelvic examination to ultrasound measurement for assessment of gestational age in the first trimester of pregnancy.

OBJECTIVE: To compare the accuracy of bimanual pelvic examination to ultrasound in the assessment of gestational age and to evaluate resident and faculty accuracy, and residents' learning to perform pelvic examination. STUDY DESIGN: Prospective, blinded, descriptive, correlational study of clinical bimanual examination versus ultrasound dating pregnancy prior to first-trimester abortion. Women scheduled to undergo abortion received transvaginal ultrasound assessment of gestational age. A resident and faculty physician, blinded to the ultrasound results, each performed a pelvic examination immediately prior to the procedure. The pelvic examination assessments were compared to the ultrasound calculations of gestational age. The absolute value of the difference between the bimanual examination and ultrasound dating were compared using the paired t test. Linear regression was used to evaluate the learning of residents. RESULTS: The pelvic examination agreed with the ultrasound (+/- 2 weeks) in 92% of cases for faculty and 75% for residents. Accuracy of the resident examinations did not change over their two-month rotations. CONCLUSION: If pelvic examination alone is used to assess gestational age in the setting of first-trimester abortion, 8% of patients may experience unnecessary interventions, possibly leading to a greater risk of complications.

Abortion, Induced↗

PubMed2002

Characteristics and initial diagnoses in women presenting to a referral center for vulvovaginal disorders in 1996-2000.

OBJECTIVE: To describe the demographics, presenting symptoms, physical examination and laboratory findings, and initial diagnoses in a cohort of women referred for evaluation of vulvovaginal problems. STUDY DESIGN: Descriptive review of medical records of new patients referred for evaluation of vulvar problems between January 1, 1996, and December 31, 1999. Electronic medical records and other documents were manually abstracted. RESULTS: Three hundred twenty-two women met the study criteria. The majority were Caucasian (93.8%) and married (63.9%). The mean age was 41 years, with a range of 13-88. The majority reported at least one vaginal delivery (72.9%) or cesarean section (10.6%). The most common symptoms were vulvar pain (86.3%), dyspareunia (70.8%), itching (36.0%) and skin changes (18.0%). Most patients received a diagnosis in more than one evaluation category. Prevalent diagnoses included Bartholin fossa pain (12.1%), vulvar vestibulitis (19.9%), restriction and fissuring of the posterior labial commissure (20.1%), dysesthetic vulvodynia (32.3%), pelvic floor dysfunction (39.8%) and dermatologic conditions (47.5%). CONCLUSION: Women presenting for evaluation of vulvar disorders represent a heterogeneous population. Among women with vulvar pain, abnormalities of the skin and pelvic floor are common and should be ruled out prior to making a diagnosis of vulvar vestibulitis or dysesthetic vulvodynia.

Adolescent↗

PubMed2002

Noncontraceptive applications of the levonorgestrel intrauterine system.

The introduction of an intrauterine system that releases 20 mg of levonorgestrel (LNG-IUS) directly to the uterine lining has ushered in a new era for the intrauterine device. The LNG-IUS reduces menstrual bleeding and dysmenorrhea, and is an effective nonsurgical treatment for idiopathic menorrhagia in premenopausal women. Women using the device experience significant reductions in menstrual flow and increases in hemoglobin. Abnormal uterine bleeding has become a primary indication for the use of this intrauterine device in Europe, and it is an emerging off-label indication in the United States. Women randomized to the use of the device experience a reduction in bleeding similar to that obtained by hysteroscopic procedures, and satisfaction with the results is high. The device also provides endometrial protection in combination with estrogen as postmenopausal hormone replacement therapy. In this paper, the growing literature on the emerging noncontraceptive indications for the LNG-IUS is reviewed.

Drug Delivery Systems↗