Cargando…

Endometrial safety and bleeding profile of a 17β-estradiol/progesterone oral softgel capsule (TX-001HR)(∗)

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 amenorrhea. METHODS: The REPLENISH trial (NCT01942668) evaluated u...

Descripción completa

Detalles Bibliográficos
Autores principales:	Mirkin, Sebastian, Goldstein, Steven R., Archer, David F., Pickar, James H., Graham, Shelli, Bernick, Brian
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Lippincott-Raven Publishers 2020
Materias:	Original Studies
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7147409/ https://www.ncbi.nlm.nih.gov/pubmed/31913228 http://dx.doi.org/10.1097/GME.0000000000001480

Ejemplares similares

SAT-238 Predictors Of Vaginal/Uterine Bleeding With Oral TX-001HR (Estradiol and Progesterone) Capsules Taken For Menopausal Vasomotor Symptoms
por: Constantine, Ginger, et al.
Publicado: (2019)

17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial
por: Kaunitz, Andrew M., et al.
Publicado: (2020)

Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR
por: Kingsberg, Sheryl A., et al.
Publicado: (2017)

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)
por: Lobo, Rogerio A., et al.
Publicado: (2019)

Oral 17β-estradiol/progesterone (TX-001HR) and quality of life in postmenopausal women with vasomotor symptoms
por: Simon, James A., et al.
Publicado: (2019)

Improvement in sleep outcomes with a 17β-estradiol–progesterone oral capsule (TX-001HR) for postmenopausal women
por: Kagan, Risa, et al.
Publicado: (2018)

Pharmacokinetic studies of solubilized estradiol given vaginally in a novel softgel capsule
por: Pickar, J. H., et al.
Publicado: (2016)

Physical characteristics and properties of estradiol softgel vaginal inserts
por: Simon, James A., et al.
Publicado: (2019)

Evaluation of clinical meaningfulness of estrogen plus progesterone oral capsule (TX-001HR) on moderate to severe vasomotor symptoms
por: Constantine, Ginger D., et al.
Publicado: (2019)

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
por: Constantine, Ginger D., et al.
Publicado: (2017)

TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol
por: Archer, David F., et al.
Publicado: (2017)

TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial
por: Constantine, Ginger D., et al.
Publicado: (2020)

A randomized, double-blind, placebo-controlled phase 2 pilot trial evaluating a novel, vaginal softgel capsule containing solubilized estradiol
por: Pickar, James H., et al.
Publicado: (2016)

Pharmacokinetics of the first combination 17β-estradiol/progesterone capsule in clinical development for menopausal hormone therapy
por: Pickar, James H., et al.
Publicado: (2015)

Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial
por: Liu, James H., et al.
Publicado: (2020)

MON-006 Progesterone Receptor Expression in Endometrial Biopsies After 12 Weeks of Exposure to A 4-µg E2 Softgel Vaginal Insert or Placebo
por: Simon, James A, et al.
Publicado: (2020)

SAT-237 Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms
por: Santoro, Nanette, et al.
Publicado: (2019)

Evaluation of endometrial progesterone receptor expression after 12 weeks of exposure to a low-dose vaginal estradiol insert
por: Mirkin, Sebastian, et al.
Publicado: (2021)

Effects of combined 17β-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial
por: Black, Denise R., et al.
Publicado: (2020)

SAT-LB003 Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial
por: Constantine, Ginger, et al.
Publicado: (2019)

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
por: Constantine, Ginger D., et al.
Publicado: (2017)

Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17β-estradiol/progesterone
por: Mirkin, Sebastian, et al.
Publicado: (2019)

Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies
por: Stanczyk, Frank Z., et al.
Publicado: (2019)

SAT-239 Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating
por: Liu, James, et al.
Publicado: (2019)

SAT-001 Clinically Meaningful Effects of E2/P4 Oral Capsule in Treating Vasomotor Symptoms
por: Constantine, Ginger, et al.
Publicado: (2020)

Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption
por: Trimboli, Pierpaolo, et al.
Publicado: (2018)

Bioavailability of AREDS1 micronutrients from softgel capsules and tablets: a pilot study
por: Johnson, Elizabeth J., et al.
Publicado: (2014)

Effects of E2/P4 oral capsules on bone turnover in women with vasomotor symptoms
por: McClung, Michael R., et al.
Publicado: (2022)

SAT-021 Effects of E2/P4 Oral Capsules on Bone Turnover in Women with Vasomotor Symptoms
por: Constantine, Ginger, et al.
Publicado: (2020)

Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review
por: Constantine, Ginger D., et al.
Publicado: (2019)

Systemic estradiol levels with low-dose vaginal estrogens
por: Santen, Richard J., et al.
Publicado: (2019)

Effects of clomiphene citrate plus estradiol or progesterone on endometrial ultrastructure: An RCT
por: Taheripanah, Robabeh, et al.
Publicado: (2020)

Prescribing of FDA-approved and compounded hormone therapy differs by specialty
por: Constantine, Ginger D., et al.
Publicado: (2016)

Ulipristal Acetate Interferes With Actin Remodeling Induced by 17β-Estradiol and Progesterone in Human Endometrial Stromal Cells
por: Shortrede, Jorge E., et al.
Publicado: (2018)

Acupuncture on the Endometrial Morphology, the Serum Estradiol and Progesterone Levels, and the Expression of Endometrial Leukaemia-inhibitor Factor and Osteopontin in Rats
por: Fu, Houju, et al.
Publicado: (2011)

Liquid and softgel capsules of l-thyroxine results lower serum thyrotropin levels more than tablet formulations in hypothyroid patients
por: Benvenga, Salvatore
Publicado: (2019)

SAT-013 Segesterone Acetate (SA) Serum Levels with a Statistical Model of Continued Use of the SA/Ethinyl Estradiol (EE) Contraceptive Vaginal System
por: Liu, James H, et al.
Publicado: (2020)

Exploring the Effect of Enbrel Softgels on PWI Indicators in VCIND Patients
por: Cui, Lei, et al.
Publicado: (2022)

Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants
por: Peters, Erica N, et al.
Publicado: (2021)

The Connection of the Level of Estradiol in Serum and Obesity with the Endometrial Bleeding in Postmenopausal Women
por: Tofiloska, Valentina, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_u5t6djlemvsg7t88f4t9m3708b