Brian Bernick
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View article: Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins
Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins Open
Objective: The objective of the present document was to review/summarize reported outcomes compared between menopausal hormone therapy (MHT) containing estradiol (E2) versus other estrogens and MHT with progesterone (P4) versus progestins …
View article: COVID-19 Impact on Women's Health
COVID-19 Impact on Women's Health Open
Introduction The COVID-19 pandemic and associated social distancing and/or lockdowns have impacted social and personal interactions. Objective To assess COVID's impact on partner relationships, sexual activity, family planning, and menopau…
View article: Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins
Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins Open
Objective: The objective of the present document was to review/summarize reported outcomes compared between menopausal hormone therapy (MHT) containing estradiol (E2) versus other estrogens and MHT with progesterone (P4) versus progestins …
View article: Evaluation of endometrial progesterone receptor expression after 12 weeks of exposure to a low-dose vaginal estradiol insert
Evaluation of endometrial progesterone receptor expression after 12 weeks of exposure to a low-dose vaginal estradiol insert Open
Objective: To evaluate endometrial progesterone receptor (PGR) expression in menopausal women who used vaginal 4-μg and 10-μg estradiol (E2) inserts or placebo. Methods: REJOICE was a randomized, placebo-controlled trial investigating vagi…
View article: Determinants of attained estradiol levels in response to oral estradiol plus progesterone therapy
Determinants of attained estradiol levels in response to oral estradiol plus progesterone therapy Open
Adjusting for E2 dose and baseline E2 level, on-trial E2 levels were significantly associated with time since menopause, current smoking, and current alcohol use. Practitioners should consider these factors in individual women to achieve a…
View article: Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial
Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial Open
Objective: To examine the impact of a single-capsule 17β-estradiol (E2)/progesterone (P4) on weight and blood pressure (BP) when treating moderate to severe vasomotor symptoms in postmenopausal women with a uterus. Methods: Healthy postmen…
View article: Uterine bleeding with hormone therapies in menopausal women: a systematic review
Uterine bleeding with hormone therapies in menopausal women: a systematic review Open
Uterine bleeding is a common reason why women discontinue menopausal hormone therapy (HT). This systematic review compared bleeding profiles reported in studies for continuous-combined HT approved in North America and Europe for moderate t…
View article: Estradiol softgel inserts for the treatment of VVA symptoms: an expert opinion
Estradiol softgel inserts for the treatment of VVA symptoms: an expert opinion Open
AE: adverse event; AUC: area under the concentration-time curve; BMI: body mass index; Cavg: average concentration; CI: confidence interval; Cmax: maximum concentration; Cmin: minimum concentration; E2: estradiol; FDA: Food and Drug Admini…
View article: Long-Lasting, Patient-Controlled, Procedure-Free Contraception: A Review of Annovera with a Pharmacist Perspective
Long-Lasting, Patient-Controlled, Procedure-Free Contraception: A Review of Annovera with a Pharmacist Perspective Open
Annovera (segesterone acetate and ethinyl estradiol vaginal system) is a US Food and Drug Administration FDA-approved long-lasting, reversible contraceptive that is fully administered by the user and does not require a procedure for insert…
View article: Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial
Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial Open
Objective: To evaluate the effect of a single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy on mammograms and breasts in postmenopausal women after 1 year of use. Methods: In the 12-month, phase 3, randomiz…
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: Effects of Estradiol Dose and Serum Estradiol Levels on Metabolic Measures in Early and Late Postmenopausal Women in the REPLENISH Trial
Effects of Estradiol Dose and Serum Estradiol Levels on Metabolic Measures in Early and Late Postmenopausal Women in the REPLENISH Trial Open
Background: To identify the association of estradiol (E2) dose and serum E2 levels with metabolic measures in early (Material and Methods: This is a post hoc analysis of a multicenter randomized clinical trial in the United States. Four do…
View article: SAT-013 Segesterone Acetate (SA) Serum Levels with a Statistical Model of Continued Use of the SA/Ethinyl Estradiol (EE) Contraceptive Vaginal System
SAT-013 Segesterone Acetate (SA) Serum Levels with a Statistical Model of Continued Use of the SA/Ethinyl Estradiol (EE) Contraceptive Vaginal System Open
The novel, ring-shaped, contraceptive vaginal system (CVS; Annovera™), contains 103 mg of SA and 17.4 mg of EE, and delivers a mean dose of SA 0.15/EE 0.013 mg/day. The CVS was designed to last thirteen cycles in a 21 day-in/7 day-out regi…
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: MON-006 Progesterone Receptor Expression in Endometrial Biopsies After 12 Weeks of Exposure to A 4-µg E2 Softgel Vaginal Insert or Placebo
MON-006 Progesterone Receptor Expression in Endometrial Biopsies After 12 Weeks of Exposure to A 4-µg E2 Softgel Vaginal Insert or Placebo Open
The softgel, vaginal 17β-estradiol (E2) insert (TX-004HR) significantly improved the maturation index of the vaginal epithelium, dyspareunia and vaginal dryness in menopausal women with vulvar and vaginal atrophy (VVA) and moderate to seve…
View article: Association of oral estradiol dose/levels with coagulation measures in early/late postmenopausal women
Association of oral estradiol dose/levels with coagulation measures in early/late postmenopausal women Open
OBJECTIVE: This study evaluated associations of estradiol (E2) dose and serum E2 levels with coagulation/anti-coagulation measures in early (<6 years) compared with late (≥10 years) postmenopausal women. METHODS: Postmenopausal women from …
View article: Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral softgel capsule (TX-001HR)∗
Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral softgel capsule (TX-001HR)∗ Open
Objective: The aim of the study was to evaluate the effect of a single-capsule 17β-estradiol/progesterone (E2/P4), TX-001HR, on endometrial safety, to report on amenorrhea and bleeding patterns of users, and to identify predictors of ameno…
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: Physical characteristics and properties of estradiol softgel vaginal inserts
Physical characteristics and properties of estradiol softgel vaginal inserts Open
Objective: TX-004HR is a low-dose estradiol (E2) softgel vaginal insert designed to be rapidly dissolving and mucoadhesive. This report describes the physical attributes and pharmacokinetic parameters of the softgel vaginal insert evaluate…
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: Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms
Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms Open
Objective: This study aimed to evaluate the effects of TX-001HR (17β-estradiol [E2] and progesterone [P4] in a single oral capsule) on cardiometabolic markers and outcomes. Methods: Four E2/P4 doses (1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/50 m…
View article: A combined, bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause
A combined, bioidentical, oral, 17β-estradiol and progesterone capsule for the treatment of moderate to severe vasomotor symptoms due to menopause Open
Introduction: Many women seek treatment to alleviate menopausal vasomotor symptoms (VMS). Numerous women use combination compounded hormone therapy (CHT) to achieve the benefits of estrogen/progesterone for endometrial protection. TX-001HR…
View article: The MATE survey: men's perceptions and attitudes towards menopause and their role in partners’ menopausal transition
The MATE survey: men's perceptions and attitudes towards menopause and their role in partners’ menopausal transition Open
Objective: The perceptions and attitudes of menopause shared by men are largely unknown. This analysis characterized men's awareness and their understanding of their partner's menopausal transition. Methods: A 35-question, online survey wa…
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-239 Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating
SAT-239 Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating Open
In the phase 3 REPLENISH trial of postmenopausal women with a uterus, TX-001HR (TherapeuticsMD, Boca Raton, FL), an oral 17β-estradiol-progesterone (E2/P4) softgel capsule, reduced moderate to severe hot flush frequency and severity and im…
View article: SAT-219 A Novel 1-Year Contraceptive Vaginal System Delivering Segesterone Acetate and Ethinyl Estradiol: Effects on Lipids and other Hepatic Proteins
SAT-219 A Novel 1-Year Contraceptive Vaginal System Delivering Segesterone Acetate and Ethinyl Estradiol: Effects on Lipids and other Hepatic Proteins Open
Annovera™ is an FDA-approved contraceptive vaginal system (CVS) releasing 150 mcg segesterone acetate (SA), a new chemical entity, and 13 mcg ethinyl estradiol (EE) per day.(1) We postulate that as a non-androgenic progestin, SA is unlikel…