Ginger D. Constantine
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View article: 17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial
17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial Open
Objective: To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial. Methods: REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, p…
View article: TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial
TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial Open
Objective: The aim of the study was to evaluate the clinically meaningful effect of oral TX-001HR (17β-estradiol [E2]/progesterone [P4]) capsules on hot flushes severity (vasomotor symptoms [VMS] severity scale) using the patient-reported …
View article: SAT-001 Clinically Meaningful Effects of E2/P4 Oral Capsule in Treating Vasomotor Symptoms
SAT-001 Clinically Meaningful Effects of E2/P4 Oral Capsule in Treating Vasomotor Symptoms Open
Hormonal therapies effectively reduce the frequency and severity of vasomotor symptoms (VMS) in menopausal women; however, whether the effect is clinically meaningful to women is typically not determined. Oral estradiol/progesterone (E2/P4…
View article: SAT-021 Effects of E2/P4 Oral Capsules on Bone Turnover in Women with Vasomotor Symptoms
SAT-021 Effects of E2/P4 Oral Capsules on Bone Turnover in Women with Vasomotor Symptoms Open
Menopausal hormone therapy slows bone turnover and reduces the risk of osteoporotic fractures. The objective of this post hoc analysis was to evaluate bone turnover markers (BTM) in the phase 3 REPLENISH trial, which evaluated vasomotor sy…
View article: Systemic estradiol levels with low-dose vaginal estrogens
Systemic estradiol levels with low-dose vaginal estrogens Open
Objectives: To critically evaluate published systemic estradiol levels during use of low-dose vaginal estrogens considering detection method and estrogen dose; describe challenges with accurately measuring estradiol; and determine the norm…
View article: Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia
Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia Open
Objective: The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). …
View article: SAT-237 Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms
SAT-237 Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms Open
Difficulty sleeping is a common complaint of postmenopausal women. In the REPLENISH trial, the oral 17β-estradiol/progesterone (E2/P4) softgel capsule (TX-001HR; 1 mg E2/100 mg P4 FDA approved as BIJUVA(TM); TherapeuticsMD, Boca Raton, FL)…
View article: SAT-238 Predictors Of Vaginal/Uterine Bleeding With Oral TX-001HR (Estradiol and Progesterone) Capsules Taken For Menopausal Vasomotor Symptoms
SAT-238 Predictors Of Vaginal/Uterine Bleeding With Oral TX-001HR (Estradiol and Progesterone) Capsules Taken For Menopausal Vasomotor Symptoms Open
Vaginal bleeding associated with hormone therapy (HT) is the most common reason for treatment discontinuation. Cumulative amenorrhea rates (no bleeding or spotting for 13 cycles) ranging from 23% to 49% with current HT options(1-3) are rel…
View article: SAT-LB003 Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial
SAT-LB003 Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial Open
Smoking has previously been reported to result in decreases in estradiol exogenous metabolism(1,2,3) and may influence the efficacy of hormone therapy (HT) in postmenopausal women(2,3). Importantly, differences in smoking rates among clini…
View article: Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review
Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review Open
Objective: The aim of the study was to systematically review studies that evaluated endometrial hyperplasia or cancer incidence with unopposed vaginal estrogens. Methods: PubMed and EMBASE were searched from inception to August 2017 for re…
View article: TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women
TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women Open
Objective: This study aimed to evaluate improvement of dyspareunia and associated vaginal dryness with a 17β-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal a…
View article: Estradiol and progesterone bioavailability for moderate to severe vasomotor symptom treatment and endometrial protection with the continuous-combined regimen of TX-001HR (oral estradiol and progesterone capsules)
Estradiol and progesterone bioavailability for moderate to severe vasomotor symptom treatment and endometrial protection with the continuous-combined regimen of TX-001HR (oral estradiol and progesterone capsules) Open
Objective: In the REPLENISH trial, women receiving TX-001HR—an oral, softgel capsule, combining 17β-estradiol (E2) and progesterone (E2 mg/P4 mg 1/100, 0.5/100), had significantly improved vasomotor symptoms, while having their endometrium…
View article: Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone
Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone Open
Objective: To characterize the impact of TX-001HR on the relationship between vasomotor symptom (VMS) improvement and quality of life and sleep. Methods: REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, …
View article: Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women
Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women Open
Objective: The aim of the study was to evaluate the effects of TX-001HR, a single-capsule 17β-estradiol–progesterone on sleep parameters in postmenopausal women with vasomotor symptoms (VMS) using the Medical Outcomes Study (MOS)-Sleep sca…
View article: Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms
Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms Open
Objective: The aim of this study was to determine the clinical meaningfulness of TX-001HR in reducing moderate to severe vasomotor symptoms (VMS) in menopausal women with a uterus. Methods: In the REPLENISH study (NCT01942668), women with …
View article: Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors
Increased Incidence of Endometrial Cancer Following the Women's Health Initiative: An Assessment of Risk Factors Open
Endometrial cancer rate increases after the first publication of WHI data in 2002 may be associated with the decreased use of approved estrogen-progestogen therapy, the increase in CBHT use, and the prevalence of obesity and diabetes; pote…
View article: Estradiol vaginal inserts (4 µg and 10 µg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data
Estradiol vaginal inserts (4 µg and 10 µg) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data Open
The recently FDA-approved E2 softgel vaginal insert (4 µg and 10 µg) was safe and effective over 12 weeks for treating moderate to severe dyspareunia due to menopausal VVA with minimal systemic E2 levels.
View article: Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial
Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial Open
Objective: To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA. Methods: REJOICE was a 12-wee…
View article: Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women
Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women Open
TX-004HR was efficacious for treating symptomatic VVA, and it demonstrated a consistency of effect when women's age, BMI, uterine status, pregnancy status, and vaginal births were evaluated. Clinical Trial Identifier: NCT02253173.
View article: A vaginal estradiol softgel capsule, TX-004HR, has negligible to very low systemic absorption of estradiol: Efficacy and pharmacokinetic data review
A vaginal estradiol softgel capsule, TX-004HR, has negligible to very low systemic absorption of estradiol: Efficacy and pharmacokinetic data review Open
This paper reviews the efficacy, safety, and systemic absorption of estradiol with TX-004HR, an investigational, low-dose 17β-estradiol vaginal softgel capsule, designed to treat vulvar and vaginal atrophy (VVA) in postmenopausal women, wi…
View article: Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR
Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR Open
Objective: TX-004HR is an investigational, muco-adhesive, vaginal, softgel capsule containing low-dose, solubilized, 17β-estradiol designed to treat postmenopausal vulvar and vaginal atrophy (VVA) and improve user experience without an app…
View article: TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol
TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol Open
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 tr…
View article: 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
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 Open
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…
View article: TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women with Vulvar and Vaginal Atrophy: The REJOICE Trial
TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women with Vulvar and Vaginal Atrophy: The REJOICE Trial Open
Introduction TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR…
View article: Prescribing of FDA-approved and compounded hormone therapy differs by specialty
Prescribing of FDA-approved and compounded hormone therapy differs by specialty Open
Objective: To determine the prescribing patterns of general practitioners (GPs), obstetrician/gynecologists (OB/GYNs), and wellness physicians (WPs) of menopausal hormone therapy (HT) for both compounded (CHT) and Food and Drug Administrat…
View article: Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries
Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries Open
Objective To assess women’s behaviours and attitudes regarding the treatment of menopausal symptoms in five European countries. Study design Women aged ≥45 years in France, Germany, Italy, Spain, and the United Kingdom participated in an i…
View article: Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased
Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased Open
On the basis of extrapolated data from numbers of prescriptions reported by pharmacists participating in the survey, the volume of CHT seems to approach that of Food and Drug Administration (FDA)-approved menopausal hormone therapy, and gr…