Mitchell Creinin - Academia.edu (original) (raw)

Papers by Mitchell Creinin

Perspectives on Sexual and Reproductive Health, 2009

Contraception, 2007

curettage on a separate day following initial visit in the clinic. Understanding the lack of effi... more curettage on a separate day following initial visit in the clinic. Understanding the lack of efficiency in our system, we instituted three changes over a two year period: procedures were relocated to the out patient area, same day service was initiated and manual vacuum aspiration (MVA) was introduced. Our objective was to assess the effects of these changes on the waiting period in days from the intake visit to the day of termination procedure. Materials and Methods: Data was obtained on 625 patients who underwent a surgical termination of pregnancy from February 2004 to January 2006. The clinical sessions were compiled into four groups based on each progressive change in practice. Results: The waiting period decreased from 20.3 days to 3.6 days and the mean gestational age at procedure decreased from 11 weeks to 9 weeks. The percentage of procedures performed at b9 weeks gestational age increased from 1.7% to 40%. The number of procedures per session was increased by 52.7%. The percentage of same day procedures increased from 7% to 62%. Conclusion: We improved quality and efficiency of care provided to our patients by reducing the waiting period and peforming procedures at earlier gestational age.

Contraception, 2009

Incarcerated women have had limited access to health care prior to their arrest. Although their i... more Incarcerated women have had limited access to health care prior to their arrest. Although their incarceration presents an opportunity to provide them with health care, their reproductive health needs have been overlooked. We performed a cross-sectional study of a nationally representative sample of 950 correctional health providers who are members of the Academy of Correctional Health Providers. A total of 405 surveys (43%) were returned, and 286 (30%) were eligible for analysis. Most ineligible surveys were from clinicians at male-only facilities. Of eligible respondents, 70% reported some degree of contraception counseling for women at their facilities. Only 11% provided routine counseling prior to release. Seventy percent said that their institution had no formal policy on contraception. Thirty-eight percent of clinicians provided birth control methods at their facilities. Although the most frequently counseled and prescribed method was oral contraceptive pills, only 50% of providers rated their oral contraceptive counseling ability as good or very good. Contraception counseling was associated with working at a juvenile facility, and with screening for sexually transmitted infections. Contraception does not appear to be integrated into the routine delivery of clinical services to incarcerated women. Because the correctional health care system can provide important clinical and public health interventions to traditionally marginalized populations, services for incarcerated women should include access to contraception.

Obstetrics & Gynecology, 2010

Objective-To compare contraceptive efficacy, safety, and acceptability of C31G and nonoxynol-9 sp... more Objective-To compare contraceptive efficacy, safety, and acceptability of C31G and nonoxynol-9 spermicidal gels. Methods-We conducted a multicenter, randomized, double-masked, controlled trial to assess whether a gel containing the spermicide C31G was non-inferior to a commercially available product containing nonoxynol-9. Participants were healthy, sexually active females ages 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. Sample size was calculated at a 2.5% significance level using a one-sided test, based on assumed 6-month pregnancy probability of 15% in the Conceptrol group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. Results-Nine-hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized subjects with at least one episode of coitus (modified intentto-treat group), six-month pregnancy probabilities were 12.0% (95% confidence interval (CI) 9.3-14.7%) and 12.0% (95%CI 8.7-15.3%) for C31G and nonoxynol-9 respectively. Twelve-month pregnancy probabilities were 13.8% (95%CI 7.6-20%) for C31G and 19.8% (95%CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product, and neither occurred the C31G group. Three-fourths of users in either group reported that they liked their assigned study product. Approximately 40% of subjects discontinued prematurely for reasons other than pregnancy, with 11% lost to follow-up. Conclusion-C31G demonstrated noninferior contraceptive efficacy compared to nonoxynol-9. Both products were safe and acceptable. C31G may provide another marketable option for women seeking spermicidal contraception.

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2008

Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In v... more Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In vitro data suggest that lime juice is virucidal, but only at cytotoxic concentrations. This is the first controlled, randomized safety trial of lime juice applied to the human vagina. Forty-seven women were randomized to apply water or lime juice (25%, 50%, or undiluted) intravaginally twice daily for two 6-day intervals, separated by a 3-week washout period. Product application also was randomized: during 1 interval, product was applied using a saturated tampon and in the other by douche. Vaginal pH, symptoms, signs of irritation observed via naked eye examination and colposcopy, microflora, and markers of inflammation in cervicovaginal lavages were evaluated after 1 hour and on days 3 and 7. The largest reduction in pH was about one-half a pH unit, seen 1 hour after douching with 100% lime juice. We observed a dose-dependent pattern of symptoms and clinical and laboratory findings that were consistent with a compromised vaginal barrier function. The brief reduction in pH after vaginal lime juice application is unlikely to be virucidal in the presence of semen. Lime juice is unlikely to protect against HIV and may actually be harmful.

Contraception, 2007

Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirr... more Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. Methods: We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. Results: CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR = 2.02, 95% confidence interval = 0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. Conclusion: CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials. D

Contraception, 2006

As health care providers, we are committed to the best possible patient care. The ability to prov... more As health care providers, we are committed to the best possible patient care. The ability to provide that level of care to our patients is based in no small part on the availability of accurate clinical information about drug and device usage that reflects actual clinical issues of importance to the clinical decision-making process. The dissemination of inaccurate, misleading or nonclinically relevant information, regardless of the intentions or reasons, can lead to innuendo, presumption and conjecture concerning clinical outcomes and do harm to the very patients such information is meant to protect.

Contraception, 2000

Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or metho... more Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons. This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age. We identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age. We found that efficacy decreases with increasing gestational age (p<0.001), and differences by regimen are not statistically significant except at gestational age > or =57 days. For gestations < or =49 days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For > or =57 days, success was lower for mifepristone/misoprostol (85%, 95% confidence interval 78-91%) than for mifepristone/other prostaglandin analogues 95% (CI 91-98%, p = 0.006). For mifepristone/misoprostol, using > or =2 prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages. We conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at < or =49 days gestation but may have lower efficacy at longer gestation.

Contraception, 2006

OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of... more OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of tubal sterilization rates. METHODS: This study used cross-sectional data collected by the 2002 National Survey of Family Growth. The survey is designed to represent women and ...

Contraception, 2005

In an attempt to improve efficacy for women who desire medical management of early pregnancy fail... more In an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 Ag, vaginally (pv), for the treatment of EPF. Methods: We enrolled 30 women with EPF in this pilot clinical trial. All women used misoprostol 800 Ag, pv, 24 h after ingesting 200 mg mifepristone. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 1 week after treatment. Participants were offered a repeat dose of misoprostol if the pregnancy had not been expelled at the first follow-up. Results: The expulsion rate with one dose of misoprostol was 90% (95% CI = 79-100%). The overall success rate of the treatment was 93% (95% CI = 84-100%).

Background: In an attempt to improve efficacy for women who desire medical management of early pr... more Background: In an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 Ag, vaginally (pv), for the treatment of EPF. Methods: We enrolled 30 women with EPF in this pilot clinical trial. All women used

Contraception, 2015

To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contr... more To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

Obstetrics and Gynecology, 2003

between women with leiomyomata and the US female population were small. However, differences in s... more between women with leiomyomata and the US female population were small. However, differences in sexual functioning scores between women with leiomyomata and healthy women were significant on all subscales, at least at the .05 level, with effect sizes ranging from medium to large (Ϫ0.42 to Ϫ1.16). Furthermore, women with leiomyomata did not significantly differ from women with female sexual arousal disorder with respect to dyspareunia. Among women with leiomyomata, several aspects of sexual functioning were significantly related to TIUV, including desire, orgasm, and dyspareunia (P ϭ .026, .021, and .019, respectively).

Fertility and Sterility, 2007

OBJECTIVE: To develop a safe, non-hormonal and reversible contraceptive using Interference RNA (R... more OBJECTIVE: To develop a safe, non-hormonal and reversible contraceptive using Interference RNA (RNAi).

Contraception, 2007

curettage on a separate day following initial visit in the clinic. Understanding the lack of effi... more curettage on a separate day following initial visit in the clinic. Understanding the lack of efficiency in our system, we instituted three changes over a two year period: procedures were relocated to the out patient area, same day service was initiated and manual vacuum aspiration (MVA) was introduced. Our objective was to assess the effects of these changes on the waiting period in days from the intake visit to the day of termination procedure.

Contraception, 2015

Objective: To evaluate if ibuprofen 800 mg reduces pain with intrauterine device (IUD) insertion ... more Objective: To evaluate if ibuprofen 800 mg reduces pain with intrauterine device (IUD) insertion among U.S. women. Study design: We conducted a randomized, double-blind, placebo-controlled trial of women undergoing IUD insertion approximately 2-6 weeks following first-trimester uterine aspiration. Subjects were randomized to receive ibuprofen 800 mg or placebo 30-45 min prior to IUD insertion. A 100-mm visual analog scale (VAS) was administered to measure pain after speculum insertion (baseline) and immediately following IUD insertion. Results: A total of 202 women were enrolled, with 101 randomized to each group (ibuprofen or placebo). Sociodemographic characteristics and baseline VAS scores were similar between groups. The median pain score with IUD insertion was 41.5 mm in the placebo group and 38.0 mm in the ibuprofen group (p=.50). Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently. Overall, median pain scores were 17.5 mm higher in nulliparous women than parous women (p=.004). Median pain scores did not differ by age, IUD-type, history of dysmenorrhea or time since aspiration. Conclusions: Administration of ibuprofen 800 mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women. Overall, nulliparous women report more pain with IUD insertion than multiparous women.

Shoupe/Contraception, 2011

Perspectives on Sexual and Reproductive Health, 2009

Contraception, 2007

curettage on a separate day following initial visit in the clinic. Understanding the lack of effi... more curettage on a separate day following initial visit in the clinic. Understanding the lack of efficiency in our system, we instituted three changes over a two year period: procedures were relocated to the out patient area, same day service was initiated and manual vacuum aspiration (MVA) was introduced. Our objective was to assess the effects of these changes on the waiting period in days from the intake visit to the day of termination procedure. Materials and Methods: Data was obtained on 625 patients who underwent a surgical termination of pregnancy from February 2004 to January 2006. The clinical sessions were compiled into four groups based on each progressive change in practice. Results: The waiting period decreased from 20.3 days to 3.6 days and the mean gestational age at procedure decreased from 11 weeks to 9 weeks. The percentage of procedures performed at b9 weeks gestational age increased from 1.7% to 40%. The number of procedures per session was increased by 52.7%. The percentage of same day procedures increased from 7% to 62%. Conclusion: We improved quality and efficiency of care provided to our patients by reducing the waiting period and peforming procedures at earlier gestational age.

Contraception, 2009

Incarcerated women have had limited access to health care prior to their arrest. Although their i... more Incarcerated women have had limited access to health care prior to their arrest. Although their incarceration presents an opportunity to provide them with health care, their reproductive health needs have been overlooked. We performed a cross-sectional study of a nationally representative sample of 950 correctional health providers who are members of the Academy of Correctional Health Providers. A total of 405 surveys (43%) were returned, and 286 (30%) were eligible for analysis. Most ineligible surveys were from clinicians at male-only facilities. Of eligible respondents, 70% reported some degree of contraception counseling for women at their facilities. Only 11% provided routine counseling prior to release. Seventy percent said that their institution had no formal policy on contraception. Thirty-eight percent of clinicians provided birth control methods at their facilities. Although the most frequently counseled and prescribed method was oral contraceptive pills, only 50% of providers rated their oral contraceptive counseling ability as good or very good. Contraception counseling was associated with working at a juvenile facility, and with screening for sexually transmitted infections. Contraception does not appear to be integrated into the routine delivery of clinical services to incarcerated women. Because the correctional health care system can provide important clinical and public health interventions to traditionally marginalized populations, services for incarcerated women should include access to contraception.

Obstetrics & Gynecology, 2010

Objective-To compare contraceptive efficacy, safety, and acceptability of C31G and nonoxynol-9 sp... more Objective-To compare contraceptive efficacy, safety, and acceptability of C31G and nonoxynol-9 spermicidal gels. Methods-We conducted a multicenter, randomized, double-masked, controlled trial to assess whether a gel containing the spermicide C31G was non-inferior to a commercially available product containing nonoxynol-9. Participants were healthy, sexually active females ages 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. Sample size was calculated at a 2.5% significance level using a one-sided test, based on assumed 6-month pregnancy probability of 15% in the Conceptrol group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. Results-Nine-hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized subjects with at least one episode of coitus (modified intentto-treat group), six-month pregnancy probabilities were 12.0% (95% confidence interval (CI) 9.3-14.7%) and 12.0% (95%CI 8.7-15.3%) for C31G and nonoxynol-9 respectively. Twelve-month pregnancy probabilities were 13.8% (95%CI 7.6-20%) for C31G and 19.8% (95%CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product, and neither occurred the C31G group. Three-fourths of users in either group reported that they liked their assigned study product. Approximately 40% of subjects discontinued prematurely for reasons other than pregnancy, with 11% lost to follow-up. Conclusion-C31G demonstrated noninferior contraceptive efficacy compared to nonoxynol-9. Both products were safe and acceptable. C31G may provide another marketable option for women seeking spermicidal contraception.

JAIDS Journal of Acquired Immune Deficiency Syndromes, 2008

Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In v... more Nigerian women reportedly apply lime juice intravaginally to protect themselves against HIV. In vitro data suggest that lime juice is virucidal, but only at cytotoxic concentrations. This is the first controlled, randomized safety trial of lime juice applied to the human vagina. Forty-seven women were randomized to apply water or lime juice (25%, 50%, or undiluted) intravaginally twice daily for two 6-day intervals, separated by a 3-week washout period. Product application also was randomized: during 1 interval, product was applied using a saturated tampon and in the other by douche. Vaginal pH, symptoms, signs of irritation observed via naked eye examination and colposcopy, microflora, and markers of inflammation in cervicovaginal lavages were evaluated after 1 hour and on days 3 and 7. The largest reduction in pH was about one-half a pH unit, seen 1 hour after douching with 100% lime juice. We observed a dose-dependent pattern of symptoms and clinical and laboratory findings that were consistent with a compromised vaginal barrier function. The brief reduction in pH after vaginal lime juice application is unlikely to be virucidal in the presence of semen. Lime juice is unlikely to protect against HIV and may actually be harmful.

Contraception, 2007

Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirr... more Background: Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. Methods: We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. Results: CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR = 2.02, 95% confidence interval = 0.90-4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. Conclusion: CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials. D

Contraception, 2006

As health care providers, we are committed to the best possible patient care. The ability to prov... more As health care providers, we are committed to the best possible patient care. The ability to provide that level of care to our patients is based in no small part on the availability of accurate clinical information about drug and device usage that reflects actual clinical issues of importance to the clinical decision-making process. The dissemination of inaccurate, misleading or nonclinically relevant information, regardless of the intentions or reasons, can lead to innuendo, presumption and conjecture concerning clinical outcomes and do harm to the very patients such information is meant to protect.

Contraception, 2000

Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or metho... more Multiple clinical studies demonstrate the efficacy of medical abortion with mifepristone or methotrexate followed by a prostaglandin analogue. However, assessing predictors of success, including regimen, is difficult because of regimen variability and a lack of direct comparisons. This meta-analysis estimates rates of primary clinical outcomes of medical abortion (successful abortion, incomplete abortion, and viable pregnancy) and compares them by regimen and gestational age. We identified 54 studies published from 1991 to 1998 using mifepristone with misoprostol (18), mifepristone with other prostaglandin analogues (23), and methotrexate with misoprostol (13). Data abstracted from studies included regimen details and clinical outcomes by gestational age. We found that efficacy decreases with increasing gestational age (p<0.001), and differences by regimen are not statistically significant except at gestational age > or =57 days. For gestations < or =49 days, mean rates of complete abortion were 94-96%, incomplete abortion 2-4%, and ongoing (viable) pregnancy 1-3%. For gestations of 50-56 days, the mean rate of complete abortion was 91% (same for all regimens), incomplete abortion 5-8%, and ongoing pregnancy 3-5%. For > or =57 days, success was lower for mifepristone/misoprostol (85%, 95% confidence interval 78-91%) than for mifepristone/other prostaglandin analogues 95% (CI 91-98%, p = 0.006). For mifepristone/misoprostol, using > or =2 prostaglandin analogue doses seems to be better than a single dose for certain outcomes and gestational ages. We conclude that both mifepristone and methotrexate, when administered with misoprostol, have high levels of success at < or =49 days gestation but may have lower efficacy at longer gestation.

Contraception, 2006

OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of... more OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of tubal sterilization rates. METHODS: This study used cross-sectional data collected by the 2002 National Survey of Family Growth. The survey is designed to represent women and ...

Contraception, 2005

In an attempt to improve efficacy for women who desire medical management of early pregnancy fail... more In an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 Ag, vaginally (pv), for the treatment of EPF. Methods: We enrolled 30 women with EPF in this pilot clinical trial. All women used misoprostol 800 Ag, pv, 24 h after ingesting 200 mg mifepristone. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 1 week after treatment. Participants were offered a repeat dose of misoprostol if the pregnancy had not been expelled at the first follow-up. Results: The expulsion rate with one dose of misoprostol was 90% (95% CI = 79-100%). The overall success rate of the treatment was 93% (95% CI = 84-100%).

Background: In an attempt to improve efficacy for women who desire medical management of early pr... more Background: In an attempt to improve efficacy for women who desire medical management of early pregnancy failure (EPF), we studied the efficacy and acceptability of mifepristone 200 mg, orally (po), followed 24 h later by misoprostol 800 Ag, vaginally (pv), for the treatment of EPF. Methods: We enrolled 30 women with EPF in this pilot clinical trial. All women used

Contraception, 2015

To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contr... more To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

Obstetrics and Gynecology, 2003

between women with leiomyomata and the US female population were small. However, differences in s... more between women with leiomyomata and the US female population were small. However, differences in sexual functioning scores between women with leiomyomata and healthy women were significant on all subscales, at least at the .05 level, with effect sizes ranging from medium to large (Ϫ0.42 to Ϫ1.16). Furthermore, women with leiomyomata did not significantly differ from women with female sexual arousal disorder with respect to dyspareunia. Among women with leiomyomata, several aspects of sexual functioning were significantly related to TIUV, including desire, orgasm, and dyspareunia (P ϭ .026, .021, and .019, respectively).

Fertility and Sterility, 2007

OBJECTIVE: To develop a safe, non-hormonal and reversible contraceptive using Interference RNA (R... more OBJECTIVE: To develop a safe, non-hormonal and reversible contraceptive using Interference RNA (RNAi).

Contraception, 2007

curettage on a separate day following initial visit in the clinic. Understanding the lack of effi... more curettage on a separate day following initial visit in the clinic. Understanding the lack of efficiency in our system, we instituted three changes over a two year period: procedures were relocated to the out patient area, same day service was initiated and manual vacuum aspiration (MVA) was introduced. Our objective was to assess the effects of these changes on the waiting period in days from the intake visit to the day of termination procedure.

Contraception, 2015

Objective: To evaluate if ibuprofen 800 mg reduces pain with intrauterine device (IUD) insertion ... more Objective: To evaluate if ibuprofen 800 mg reduces pain with intrauterine device (IUD) insertion among U.S. women. Study design: We conducted a randomized, double-blind, placebo-controlled trial of women undergoing IUD insertion approximately 2-6 weeks following first-trimester uterine aspiration. Subjects were randomized to receive ibuprofen 800 mg or placebo 30-45 min prior to IUD insertion. A 100-mm visual analog scale (VAS) was administered to measure pain after speculum insertion (baseline) and immediately following IUD insertion. Results: A total of 202 women were enrolled, with 101 randomized to each group (ibuprofen or placebo). Sociodemographic characteristics and baseline VAS scores were similar between groups. The median pain score with IUD insertion was 41.5 mm in the placebo group and 38.0 mm in the ibuprofen group (p=.50). Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently. Overall, median pain scores were 17.5 mm higher in nulliparous women than parous women (p=.004). Median pain scores did not differ by age, IUD-type, history of dysmenorrhea or time since aspiration. Conclusions: Administration of ibuprofen 800 mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women. Overall, nulliparous women report more pain with IUD insertion than multiparous women.

Shoupe/Contraception, 2011