A 17β-Estradiol–Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women

Løbo, Rogerio A.; Archer, David F.; Kagan, Risa; Kaunitz, Andrew M.; Constantine, Ginger D.; Pickar, James H.; Graham, Shelli; Bernick, Brian; Mirkin, Sebastián

doi:10.1097/aog.0000000000002645

Cited by 50 publications

(88 citation statements)

References 22 publications

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“…The primary efficacy and safety endpoints were changes from baseline to weeks 4 and 12 in the frequency and severity of moderate to severe vasomotor symptoms, and the incidence of endometrial hyperplasia at 12 months. The positive results with respect to the two primary endpoints of the trial have already been reported 1 . The REPLENISH trial also investigated additional efficacy endpoints, such as quality of life 2 using the Menopause-Specific Quality of Life questionnaire, a validated questionnaire assessing four domains (vasomotor, psychosocial, physical, sexual), which showed improvement within the first 3 treatment months.…”

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confidence: 68%

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Will estradiol/progesterone capsules for oral use become the best choice for menopausal hormone therapy?

Mueck

Ruan

2019

Climacteric

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confidence: 68%

“…Perhaps the most important result of REPLENISH is the demonstration of endometrial safety using progesterone as the progestogen component 1 . This has been the subject of controversial discussion for years.…”

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confidence: 99%

Will estradiol/progesterone capsules for oral use become the best choice for menopausal hormone therapy?

Mueck

Ruan

2019

Climacteric

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“…Data from the REPLENISH trial show that, for the most part, the frequency of moderate-to-severe VMS significantly improved from week 3 to 12 for E2/P4 doses of 1 mg/ 100 mg, 0.5 mg/100 mg, and 0.25 mg/50 mg, and at weeks 6-12 for 0.5 mg/50 mg compared with placebo (p < 0.05) 25 . Significant reductions in VMS severity were observed at weeks 3-12 for 1 mg E2/100 mg P4 and 0.5 mg E2/100 mg P4, and at most weeks between 6 and 12 for 0.5 mg E2/50 mg P4 and 0.25 mg E2/50 mg P4 25 .…”

Section: Menopausal Symptomsmentioning

confidence: 97%

“…A preliminary report of the phase-3 REPLENISH trial showed multiple doses of the investigational, oral, continuous combined, solubilized E2/P4 (TX-001HR, TherapeuticsMD, Boca Raton, FL, USA: 1 mg/100 mg, 0.5 mg/100 mg, 0.5 mg/ 50 mg, 0.25 mg/50 mg) resulting in no cases of endometrial hyperplasia or cancer (n ¼ 274-306 per group) after 12 months 25 . This was the first sufficiently powered trial to identify oral P4 doses that antagonized the endometrial effects of different E2 doses (1 mg, 0.5 mg, or 0.25 mg) 25 .…”

Section: Introductionmentioning

confidence: 99%

Evidence on the use of progesterone in menopausal hormone therapy

Mirkin

2018

Climacteric

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A need exists for a regulatory agency-approved hormone therapy (HT) with naturally occurring hormones combining progesterone (P4) and estradiol (E2), since no single product contains both endogenous hormones. Many women choose HT with P4 and millions of women around the world are using unapproved, poorly regulated compounded HT. The use of natural P4 in HT results, for the most part, in favorable outcomes without deleterious effects, as shown in clinical studies of postmenopausal women. Importantly, P4 used in HT prevents endometrial hyperplasia from estrogens while helping relieve vasomotor symptoms and improving quality-of-life measures. Additionally, risk of venous thromboembolism and breast cancer does not appear to increase with use of P4 plus estrogens as shown with synthetic progestins plus estrogens in large observations studies, and no detrimental effects of P4 in HT have been found on outcomes related to cardiovascular disease or cognition. A regulatory agency-approved HT with naturally occurring E2/P4 could be an option for the millions of women who desire a bioidentical product and/or are exposed to potential risks of inadequately studied and under-regulated compounded HT.

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“…TX-001HR (TherapeuticsMD, Boca Raton, FL, USA) combines 17b-estradiol (E2) and P4 in a single, oral, softgel capsule 25 . The 1 mg E2/100 mg P4 dose was approved by the US Food and Drug Administration (FDA) as Bijuva TM (TherapeuticsMD) 26 for the treatment of moderate to severe VMS in postmenopausal women with a uterus in October 2018, the first, combined E2/P4 oral formulation approved by the FDA.…”

Section: Introductionmentioning

confidence: 99%

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

et al. 2019

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Objective: This study aimed to evaluate the effects of TX-001HR (17b-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 mg, 0.25 mg/50 mg) were compared with placebo in menopausal women with vasomotor symptoms (VMS) and a uterus in the phase 3 REPLENISH (ClinicalTrials.gov, NCT01942668) trial. Changes in lipid and coagulation parameters and blood glucose from baseline at 6, 9, and 12 months as well as cardiovascular events are summarized. Results: A total of 1835 participants took 1 capsule of daily E2/P4; 1684 received E2/P4 and 151 received placebo. No clinically significant changes in lipid parameters, coagulation factors, or glucose were observed between treatment groups. Minimal increases of potential clinical importance were observed in total cholesterol, triglycerides, and glucose at month 12 with E2/P4 (1-4%, 6-11%, and 1%, respectively) and placebo (3%, 7%, and 2%, respectively). One episode of deep venous thrombosis and three cases of cardiovascular disease were observed, similar to expected rates of these events in the general population. Conclusions: In the REPLENISH trial, postmenopausal women with VMS treated with E2/P4 had no clinically meaningful effects on lipids, glucose, or coagulation parameters compared with placebo.

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A 17β-Estradiol–Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women

Abstract: ClinicalTrials.gov, NCT01942668.

Cited by 50 publications

References 22 publications

Will estradiol/progesterone capsules for oral use become the best choice for menopausal hormone therapy?

Will estradiol/progesterone capsules for oral use become the best choice for menopausal hormone therapy?

Evidence on the use of progesterone in menopausal hormone therapy

Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms

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