Readying the workforce: evaluation of VHA's comprehensive women's health primary care provider initiative.

BACKGROUND: Veterans Health Administration (VHA) primary care providers (PCPs) often see few women, making it challenging to maintain proficiency in women's health (WH). Therefore, VHA in 2010 established Designated WH Providers, who would maintain proficiency in comprehensive WH care and be preferentially assigned women patients. OBJECTIVE: To evaluate early implementation of this national policy. METHODS: At each VHA health care system (N=140), the Women Veterans Program Manager completed a Fiscal Year 2012 workforce capacity assessment (response rate, 100%), representing the first time the national Designated WH Provider workforce had been identified. Assessment data were linked to administrative data. RESULTS: Of all VHA PCPs, 23% were Designated WH Providers; 100% of health care systems and 83% of community clinics had at least 1 Designated WH Provider. On average, women veterans comprised 19% (SD=27%) of the patients Designated WH Providers saw in primary care, versus 5% (SD=7%) for Other PCPs (P<0.001). For women veterans using primary care (N=313,033), new patients were less likely to see a Designated WH Provider than established women veteran patients (52% vs. 64%; P<0.001). CONCLUSIONS: VHA has achieved its goal of a Designated WH Provider in every health care system, and is approaching its goal of a Designated WH Provider at every hospital/community clinic. Designated WH Providers see more women than do Other PCPs. However, as the volume of women patients remains low for many providers, attention to alternative approaches to maintaining proficiency may prove necessary, and barriers to assigning new women patients to Designated WH Providers merit attention.

Weight and body composition changes during oral contraceptive use in obese and normal weight women.

BACKGROUND: Oral contraceptive (OC) use seems to have little effect on weight change in normal weight women. Most previous studies have excluded obese women, so the effect of OC use on weight change in obese women is unknown. METHODS: This analysis evaluates weight and body composition change with OC use among obese (body mass index [BMI] 30.0-39.9) and normal weight (BMI 19.0-24.9) women who were randomly assigned to two OC doses: 20 µg ethinyl estradiol (EE) and 100 µg levonorgestrel (LNG) OCs or 30 µg EE and 150 µg LNG OCs. Follow-up occurred after three to four OC cycles. Weight and body composition were measured at baseline and at follow-up using a bioelectrical impedance analyzer. RESULTS: Among 150 women (54 obese and 96 normal weight) who used OCs for 3 to 4 months, there were no clinically or statistically significant weight or body composition changes in the overall group or by BMI or OC formulation group. CONCLUSIONS: These findings add to evidence that EE/LNG OCs are not associated with short term weight or body composition change for normal weight women and suggest that OCs are also are not associated with short term weight or body composition change in obese women.

Contraceptive vaginal ring effectiveness is maintained during 6 weeks of use: a prospective study of normal BMI and obese women.

BACKGROUND: A single study shows that contraceptive vaginal ring (CVR) use for up to 35 days in women with a normal body mass index (BMI) maintains serum hormone levels sufficient to suppress ovulation. This study is intended to confirm those results and to evaluate prolonged CVR use up to 42 days in both normal BMI and obese women. STUDY DESIGN: Twenty women with a normal BMI and 20 obese women enrolled in a prospective open label clinical study of ethinyl estradiol (EE) and etonogestrel (ENG) pharmacokinetics during six weeks of use of a single CVR. Participants underwent twice-weekly evaluations to determine serum hormone concentrations, ovarian follicle development, endometrial thickness and bleeding patterns. RESULTS: Thirty-seven women completed follow-up including eighteen women with a normal BMI and nineteen obese women. EE and ENG concentrations remained in therapeutic range for all women. Follicular development and endometrial proliferation were minimal. By the sixth week, 30% of participants reported spotting or bleeding. CONCLUSIONS: A single CVR used for 6 weeks demonstrates therapeutic serum levels of EE and ENG among women with normal and obese BMI. Women who forget to remove the CVR at day 21 may well have continued contraceptive protection during the next 3 weeks.

Pharmacokinetics and ovarian suppression during use of a contraceptive vaginal ring in normal-weight and obese women.

OBJECTIVE: Many observational studies indicate higher oral contraceptive failure among obese women, but most clinical trials and physiologic studies do not support these differences. Limited data indicate higher failure rates among obese contraceptive patch users. Data regarding contraceptive vaginal ring performance in obese women are needed. STUDY DESIGN: Twenty normal weight (body mass index [BMI] 19.0-24.9; median, 21.65) and 20 obese (BMI 30.0-39.9; median, 33.7) women enrolled in a prospective study of ethinyl estradiol (EE(2)) and etonorgestrel pharmacokinetics and of ovarian follicle development, endometrial thickness, and bleeding patterns, all measured biweekly during the second cycle of contraceptive vaginal ring use. RESULTS: Thirty-seven women completed follow-up. Mean day 0-21 EE(2) concentrations were lower among obese vs normal weight women (15.0 vs 22.0 pg/mL, respectively, P = .004), whereas etonorgestrel concentrations were similar (1138 vs 1256 pg/mL, respectively, P = .39). Follicular development was minimal in both groups, with only 5 women achieving a maximum follicle diameter >13 mm at any time during 3 weeks follow-up (3 normal weight and 2 obese women); these women had serum progesterone levels <1.0. Obese women reported more bleeding or spotting than normal weight women (3.6 vs 1.4 days, respectively, P = .01). CONCLUSION: Although obese women had lower EE(2) levels during contraceptive vaginal ring use, they had excellent suppression of ovarian follicle development, similar to normal weight women. This predicts that contraceptive vaginal ring effectiveness will be similar in women with a BMI up to 39.9. The lower serum EE(2) levels in the obese women may explain the greater reported bleeding or spotting days.

Predictors of noncompliance in an oral contraceptive clinical trial.

BACKGROUND: This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. STUDY DESIGN: We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. RESULTS: One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5-46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. CONCLUSIONS: We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.

Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial.

OBJECTIVE: To assess ovarian suppression during oral contraceptive pill (OCP) use among normal-weight and obese women using two OCP doses. METHODS: This was a prospective, double-blind, randomized trial of two 21-day monophasic OCP formulations (20-microgram ethinyl estradiol [E2],/100-microgram levonorgestrel compared with 30-microgram ethinyl E2/150-microgram levonorgestrel) among normal-weight (body mass index 19.0-24.9) and obese (body mass index 30.0-39.9) women with regular menses and normal ovarian ultrasonography. Participants underwent transvaginal ultrasonography and phlebotomy twice weekly for 4 weeks during the third or fourth OCP cycle. We assessed OCP compliance using serum levonorgestrel levels. Outcomes included follicular development, endogenous E2 levels, ovulation, and self-reported bleeding patterns. RESULTS: Two hundred twenty-six women enrolled. One hundred eighty-one participants completed the study; we retained 150 consistent OCP users in the main analysis (96 normal weight, 54 obese). Consistent users of either OCP dose had substantial suppression of follicular development; obesity and follicular development were not related. Among the consistent OCP users, 2.7% ovulated during the study cycle (3 of 96 normal-weight and 1 of 54 obese participants). Two ovulations occurred with each OCP formulation. Inconsistent OCP use or nonuse during the study cycle was associated with more ovulation (P<.001). Normal-weight and obese participants had similar follicular development, endogenous estradiol levels, Hoogland scores, and bleeding patterns. CONCLUSION: Normal-weight and obese participants who were consistent OCP users experienced substantial and comparable ovarian suppression during OCP use. Higher OCP failure rates among obese women reported elsewhere are thus unlikely to be attributable to physiological differences in OCP effect. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov; NCT00827632. LEVEL OF EVIDENCE: : I.

Pharmacokinetics of a combined oral contraceptive in obese and normal-weight women.

BACKGROUND: This study was conducted to compare oral contraceptive (OC) pharmacokinetics (PK) in normal-weight [body mass index (BMI) 19.0-24.9] and obese (BMI 30.0-39.9) women. STUDY DESIGN: During the third week of the third cycle of OC use, we admitted 15 normal-weight and 15 obese women for collection of 12 venous specimens over 24 h. Using radioimmunoassay techniques, we measured levels of ethinyl estradiol (EE) and levonorgestrel (LNG). During the same cycle, women underwent twice-weekly sonography to assess ovarian follicular development and blood draws to measure endogenous estradiol (E2) and progesterone levels. RESULTS: Obese women had a lower area under the curve (AUC; 1077.2 vs. 1413.7 pg*h/mL) and lower maximum values (85.7 vs. 129.5 pg/mL) for EE than normal-weight women (p=.04 and <0.01, respectively); EE trough levels were similar between BMI groups. The similar, but smaller, differences in their LNG levels for AUC and maximum values (C(max)) were not statistically significant. While peak values differed somewhat, the LNG trough levels were similar for obese and normal-weight women (2.6 and 2.5 ng/mL, respectively). Women with greater EE AUC had smaller follicular diameters (p=.05) and lower E2 levels (p=.04). While follicular diameters tended to be larger among obese women, these differences were not statistically significant. CONCLUSION: OC hormone peak levels are lower among obese women compared to normal-weight women, but their trough levels are similar. In this small study, the observed PK differences did not translate into more ovarian follicular activity among obese OC users.