Medicine and Health Sciences Commons^™

Evolution Of Knowledge, Awareness, And Practices Regarding Zika Virus From 2016 To 2017, Quinton Katler, Prachi Godiwala, Charles J. Macri, Beth Pineles, Gary Simon, Aileen Chang, Homa Ahmadzia

Obstetrics and Gynecology Faculty Publications

Objective. Our team created a knowledge, attitudes, and practice (KAP) survey in order to assess changes over time in healthcare provider and community member awareness of Zika virus symptoms, transmission, treatment, and current and future concerns.

Study Design. The cross-sectional survey was issued at an academic medical center in Washington, DC, and via an online link to healthcare providers and community members between June and August 2016. Survey distribution was then repeated the following year, from March to April 2017. Outcomes were compared by survey year and healthcare provider versus community member status using SAS Program Version 9.4.

Results. Significant …

Geographic Disparities In The Distribution Of The U.S. Gynecologic Oncology Workforce: A Society Of Gynecologic Oncology Study, Stephanie Ricci, Ana Tergas, Kara Roche, Melissa Fairbairn, Kimberly Levinson, Micael Lopez-Acevedo, +Several Additional Authors

Obstetrics and Gynecology Faculty Publications

A recent ASCO workforce study projects a significant shortage of oncologists in the U.S. by 2020, especially in rural/underserved (R/US) areas. The current study aim was to determine the patterns of distribution of U.S. gynecologic oncologists (GO) and to identify provider-based attitudes and barriers that may prevent GOs from practicing in R/US regions. U.S. GOs (n = 743) were electronically solicited to participate in an on-line survey regarding geographic distribution and participation in outreach care. A total of 320 GOs (43%) responded; median age range was 35–45 years and 57% were male. Most practiced in an urban setting (72%) at …

The Rejoice Trial: A Phase 3 Randomized, Controlled Trial Evaluating The Safety And Efficacy Of A Novel Vaginal Estradiol Soft-Gel Capsule For Symptomatic Vulvar And Vaginal Atrophy., Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy.

METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia. Secondary endpoints included severity of vaginal dryness and vulvar and/or vaginal itching or irritation. Endometrial histology and adverse events (AEs) were included …

Tx-004hr Vaginal Estradiol Has Negligible To Very Low Systemic Absorption Of Estradiol., David F Archer, Ginger D Constantine, James A Simon, Harvey Kushner, Philip Mayer, Brian Bernick, Shelli Graham, Sebastian Mirkin, Rejoice Study Group.

Obstetrics and Gynecology Faculty Publications

OBJECTIVE: To evaluate the pharmacokinetics of TX-004HR vaginal estradiol softgel capsules when used for treating moderate-to-severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy.

METHODS: A substudy of the REJOICE trial (multicenter, double-blind, placebo-controlled, phase 3) evaluated the pharmacokinetics of 4, 10, and 25-μg TX-004HR doses once/d for 2 weeks, followed by twice/wk for 10 weeks. Serum samples obtained at 2, 4, 6, 10, and 24 hours postdose on days 1 and 14, and once on day 84, were analyzed for area under the serum concentration-time curve, tmax, Cmin, Cavg, and Cmax for estradiol, estrone, and estrone conjugates.

RESULTS: …