Female Urogenital Diseases and Pregnancy Complications Commons^™

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: …

Intrahepatic Cholestasis Of Pregnancy With Severe Elevation Of Bile Acids In The Setting Of Acute Hepatitis C Infection, Megan L. Lawlor, Agatha S. Critchfield

Obstetrics and Gynecology Faculty Publications

Intrahepatic cholestasis of pregnancy (ICP) is a complication of pregnancy resulting in elevation of serum bile acid levels. ICP is often associated with underlying liver disease, including hepatitis C. Bile acids in relationship to the acute infection of hepatitis C virus have not yet been delineated in the literature. A 26-year-old gravida 4 para 2103 with dichorionic, diamniotic twin gestation and history of intravenous drug abuse developed ICP in the setting of acute hepatitis C infection. In addition to clinical symptoms of pruritus and right upper quadrant pain, she developed severe elevation in bile acids, 239 micromol/L, and transaminitis aspartate …