estradiol transdermal system / Generic mfg. - LARVOL DELTA

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women (clinicaltrials.gov) - P4 | N=80 | Recruiting | Sponsor: University of Delaware | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date

SSP for Estradot 25micrograms/24hours patch issued (Firstwordpharma Press Release) - "In response to a significant ongoing disruption to the supply of Estradot 25micrograms/24hours patches, a Serious Shortage Protocol (SSP) has been issued by the Department of Health and Social Care (DHSC)....Effective today 3rd April 2025, SSP082, provides that for every Estradot 25micrograms/24hours patch originally prescribed either one Evorel 25 patch or one Estraderm MX 25 patch must be supplied. SSP082, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing a suitable alternative product to help reduce the number of patients having to return to their prescriber for a replacement prescription."

Commercial • Women's Health

Short Term Estradiol Administration Does Not Restore Endothelin-B Receptor-Mediated Vasodilation in Postmenopausal Women. (PubMed, Am J Physiol Heart Circ Physiol) - "E2 was administered by transdermal patch for 7 days (0.1 mg/day, Vivelle-Dot patch)...There was no effect of E2 on ETBR function (hormone*site, F(1,9) = 0.77, P = 0.40). These data demonstrate that in contrast to findings in premenopausal women, E2 administration does not restore ETBR function in postmenopausal women."

Journal

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women (clinicaltrials.gov) - P4 | N=80 | Recruiting | Sponsor: University of Delaware | Trial completion date: Jun 2025 ➔ Sep 2025 | Trial primary completion date: Jun 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date

"@Novartis @drlouisenewson first time with Estradot and seems poor application so far 🧐" (@JKHR9)

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women (clinicaltrials.gov) - P2 | N=29 | Completed | Sponsor: Cedars-Sinai Medical Center | Active, not recruiting ➔ Completed

Trial completion • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • Women's Health

"@NovartisUK When are stock issues resolving for Estradot? Not in Feb as promised." (@gas_wright)

Menopause Effects on Vascular Function (clinicaltrials.gov) - P=N/A | N=48 | Completed | Sponsor: University of Delaware | Recruiting ➔ Completed

Trial completion • Cardiovascular

ET Receptor-Mediated Vasodilation is Regulated by Estradiol in Young Women. (PubMed, Am J Physiol Heart Circ Physiol) - "Endogenous sex hormone production was suppressed with daily administration of a gonadotropin-releasing hormone antagonist (GnRHant; Ganirelix) for 10 days; E (0.1 mg/day, Vivelle dot patch) was added back on days 4-10. Furthermore, cutaneous vasodilatory responses during ET receptor blockade were blunted after E administration (control: 89±8 vs. BQ-788: 84±8 %CVC, P = 0.047). These data demonstrate that ovarian hormones, specifically E, modulates ET receptor function and contributes to the regulation of microvascular endothelial function in young women."

Clinical • Journal

Effect of Short-Term Estradiol Exposure on Endothelin-B Receptor-Mediated Vasodilation in Postmenopausal Women. (PubMed, FASEB J) - "These preliminary data suggest that short-term E2 exposure does not modulate ETB receptor function in PMW. These findings are in contrast to our observations in young women demonstrating that ETB receptors mediate vasodilation in the presence of E2. The role of alternative therapies to modulate ETB receptor function should be considered in future studies."

Journal

Estradiol Augments Sensory Nerve-Mediated Vasodilation in Young Women. (PubMed, FASEB J) - "These preliminary findings suggest that E2 enhances sensory nerve-mediated vasodilation in young women, and that this may occur through mechanisms independent of nitric oxide. Future mechanistic studies isolating the nitric oxide component and other pathways could help elucidate the role of E2 in sensory nerve-mediated vasodilation."

Journal

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Cedars-Sinai Medical Center | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ Feb 2023 | Trial primary completion date: Aug 2021 ➔ Feb 2023

Enrollment closed • Trial completion date • Trial primary completion date • Atherosclerosis • Cardiovascular • Dyslipidemia • Immunology • Inflammation • Women's Health

"@NovartisIreland Once again struggling to get 50mcg Estradot patches and being interrogated by my pharmacist about cutting 100mcg patches in half. What gives? Why can't 50mcg be supplied on a constant and consistent basis? #WomensHealth #menopause" (@ursulacurtin)

Women's Health

"Hoped #HRTsupply issues were sorted #estradot unavailable again. #menopause @Novartis #HRT" (@hop_cottage)

"Why is Estradot #Estradot @Novartis still unavailable ? #HRT #MenopauseRevolution #MenopauseAwarenessMonth #Menopause ???? Absolutely no chemists in my area can ever get them?" (@TheGreenLeopard)

Menopause Effects on Vascular Function (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: University of Delaware; Trial completion date: Jun 2021 ➔ Dec 2022; Trial primary completion date: Jun 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Cardiovascular

TREAT: Transgender Estradiol Affirming Therapy (clinicaltrials.gov) - P3; N=45; Recruiting; Sponsor: Washington University School of Medicine

New P3 trial

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Cedars-Sinai Medical Center; Trial primary completion date: Jan 2021 ➔ Aug 2021

Clinical • Trial primary completion date • Atherosclerosis • Cardiovascular • Dyslipidemia • Immunology • Inflammation • Women's Health

Effects of Anorexia Nervosa on Peak Bone Mass (clinicaltrials.gov) - P3; N=75; Completed; Sponsor: Massachusetts General Hospital; Active, not recruiting ➔ Completed; N=136 ➔ 75

Enrollment change • Trial completion • Anorexia

Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes (clinicaltrials.gov) - P3; N=121; Completed; Sponsor: Massachusetts General Hospital; Active, not recruiting ➔ Completed

Trial completion • Women's Health • IGF1

Estrogen and Serotonin on Changing Brain Chemistry (clinicaltrials.gov) - P=N/A; N=47; Completed; Sponsor: University of Colorado, Denver; Active, not recruiting ➔ Completed; N=150 ➔ 47

Enrollment change • Trial completion • MRI

"I am on a generic version of the Vivelle Dot, I have no idea why it's so hard to get hold of!" (@kamerlinlab)

Menopause Effects on Vascular Function (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: University of Delaware; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Cardiovascular

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women (clinicaltrials.gov) - P4; N=80; Recruiting; Sponsor: University of Delaware; Not yet recruiting ➔ Recruiting; Initiation date: Apr 2020 ➔ Nov 2020

Clinical • Enrollment open • Trial initiation date

A comparison of the effects of three different estrogen used for endometrium preparation on the outcome of day 5 frozen embryo transfer cycle. (PubMed, JBRA Assist Reprod) - "In FET cycles with oral (Primogyna) or transdermal patches (Estradot), or transdermal gel (Oestrogel Pump), there was no significant difference on pregnancy rates."

Journal