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List of works by Sebastian Mirkin

17β-Estradiol and natural progesterone for menopausal hormone therapy: REPLENISH phase 3 study design of a combination capsule and evidence review

scientific article published on 09 March 2015

A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture

scientific article published in August 2015

A Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Postmenopausal Women From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials

scientific article published on 20 April 2015

A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol

scientific article published on February 2016

A systematic review of the efficacy and safety of vaginal estrogen products for the treatment of genitourinary syndrome of menopause

article

A vaginal estradiol softgel capsule, TX-004HR, has negligible to very low systemic absorption of estradiol: Efficacy and pharmacokinetic data review

scientific article

An overview of current and emerging SERMs

scientific article published on 22 March 2014

An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome ⬇️

scientific article published on 05 December 2011

Assessment of the safety of long-term bazedoxifene treatment on the reproductive tract in postmenopausal women with osteoporosis: results of a 7-year, randomized, placebo-controlled, phase 3 study

scientific article

Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women

scientific article published on 31 July 2009

Bazedoxifene/conjugated estrogens for managing the burden of estrogen deficiency symptoms

scientific article published on 25 October 2013

Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries

scientific article published on 18 February 2016

Breast density changes in a randomized controlled trial evaluating bazedoxifene/conjugated estrogens

scientific article

Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial

scientific article

Breast-related effects of selective estrogen receptor modulators and tissue-selective estrogen complexes

scientific article

Changes in bone mineral density are correlated with bone markers and reductions in hot flush severity in postmenopausal women treated with bazedoxifene/conjugated estrogens

scientific article published in November 2013

Conjugated estrogen/bazedoxifene tablets for the treatment of moderate-to-severe vasomotor symptoms associated with menopause

scientific article published on March 2014

Conjugated estrogens and bazedoxifene in minority populations: pooled analysis of four phase 3 trials

scientific article

Conjugated estrogens for the treatment of menopausal symptoms: a review of safety data

scientific 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

scientific article

Current and evolving approaches to individualizing estrogen receptor-based therapy for menopausal women

scientific article

Development of conjugated estrogens/bazedoxifene, the first tissue selective estrogen complex (TSEC) for management of menopausal hot flashes and postmenopausal bone loss

scientific article

Differential effects of menopausal therapies on the endometrium

scientific article published on August 2014

Effect of 17 beta-estradiol, progesterone, synthetic progestins, tibolone, and tibolone metabolites on vascular endothelial growth factor mRNA in breast cancer cells

scientific article

Effect of conjugated estrogens/bazedoxifene on postmenopausal bone loss: pooled analysis of two randomized trials

scientific article published on 11 July 2016

Effect of raloxifene, 17beta-estradiol, and progesterone on mRNA for vascular endothelial growth factor isoforms 121 and 165 and thrombospondin-1 in Ishikawa cells

scientific article published on June 2003

Effect of tibolone and its metabolites on vascular endothelial growth factor isoforms 121 and 165 and thrombospondin-1 mRNA in Ishikawa cells

scientific article published on January 2004

Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial

scientific article

Effects of conjugated estrogens/bazedoxifene on lipid and coagulation variables: a randomized placebo- and active-controlled trial

scientific article published in June 2015

Effects of levonorgestrel, medroxyprogesterone acetate, norethindrone, and 17beta-estradiol on vascular endothelial growth factor isomers 121 and 165 in Ishikawa cells

scientific article

Effects of levonorgestrel, medroxyprogesterone acetate, norethindrone, progesterone, and 17beta-estradiol on thrombospondin-1 mRNA in Ishikawa cells

scientific article published in July 2004

Effects of mifepristone on vascular endothelial growth factor and thrombospondin-1 mRNA in Ishikawa cells: implication for the endometrial effects of mifepristone

scientific article published on October 2004

Effects of tibolone and its metabolites on Angiopoietin-1, Tie-2 and tumor necrosis factor-alpha mRNA in Ishikawa cells. Implication for tibolone's effects on the endometrium

scientific article published on 2 May 2007

Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms

Evaluation of the direct and indirect effects of bazedoxifene/conjugated estrogens on sleep disturbance using mediation modeling

scientific article

Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) tri

scientific article

Evaluation of the measurement model and clinically important differences for menopause-specific quality of life associated with bazedoxifene/conjugated estrogens

scientific article

Evolution of the tissue selective estrogen complex (TSEC).

scientific article published on July 2013

Factors associated with an optimal pregnancy outcome in an oocyte donation program

scientific article

Gene expression profiles and structural/functional features of the peri-implantation endometrium in natural and gonadotropin-stimulated cycles

scientific article

Gynecologic Safety of Conjugated Estrogens Plus Bazedoxifene: Pooled Analysis of Five Phase 3 Trials

scientific article

Hormone therapy and endometrial angiogenesis

scientific article published in December 2003

Impact of transabdominal ultrasound guidance on performance and outcome of transcervical uterine embryo transfer

scientific article

Incorporating bazedoxifene/conjugated estrogens into the current paradigm of menopausal therapy

scientific article published on 28 March 2012

Indirect comparison of bazedoxifene vs oral bisphosphonates for the prevention of vertebral fractures in postmenopausal osteoporotic women

scientific article published on 02 May 2014

Management of osteoporosis and menopausal symptoms: focus on bazedoxifene/conjugated estrogen combination

scientific article published on 07 August 2013

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene

scientific article

Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms

article published in 2019

Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR.

scientific article

Pharmacokinetics of the first combination 17β-estradiol/progesterone capsule in clinical development for menopausal hormone therapy

scientific article

Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials

scientific article

Prescribing of FDA-approved and compounded hormone therapy differs by specialty

scientific article published on October 2016

Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records

scientific article published on 13 August 2015

Qualitative cross-cultural exploration of breast symptoms and impacts associated with hormonal treatments for menopausal symptoms to inform the development of new patient-reported measurement tools

scientific article published on 4 December 2014

Qualitative cross-cultural exploration of vaginal bleeding/spotting symptoms and impacts associated with hormone therapy in post-menopausal women to inform the development of new patient-reported measurement tools

scientific article published on 5 May 2014

Recent advances help understand and improve the safety of menopausal therapies

scientific article

Response and Rebuttal to Editorial Comment on TX-004HR Improves Sexual Function as Measured by the Female Sexual Function Index in Postmenopausal Women with Vulvar and Vaginal Atrophy: The REJOICE Trial

scientific article published in December 2016

Return to fertility after cessation of a continuous oral contraceptive

scientific article published on 7 May 2008

Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada ⬇️

scientific article published on July 16, 2010

Selective estrogen receptor modulators (SERMs): a review of clinical data

scientific article

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial

scientific 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

scientific article published on 27 September 2016

TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol

scientific 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

scientific article published on 05 December 2016

The Women's EMPOWER Survey: Identifying Women's Perceptions on Vulvar and Vaginal Atrophy and Its Treatment

scientific article published on 12 February 2017

The Women's EMPOWER Survey: Women's Knowledge and Awareness of Treatment Options for Vulvar and Vaginal Atrophy Remains Inadequate

scientific article published on 12 February 2017

The effect of conjugated estrogens/bazedoxifene therapy on body weight of postmenopausal women: pooled analysis of five randomized, placebo-controlled trials

scientific article published on 25 November 2015

The tissue selective estrogen complex: a promising new menopausal therapy

scientific article published on 04 September 2012

Tissue-selective estrogen complexes for postmenopausal women

scientific article published on 11 July 2013

Use of FRAX®-based fracture risk assessments to identify patients who will benefit from osteoporosis therapy

scientific article

Vaginal pH: a simple assessment highly correlated with vaginal morphology and symptoms in postmenopausal women

scientific article published on 5 March 2018

Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial

scientific article

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