EstroGel (estradiol) / AbbVie, Besins Healthcare - LARVOL DELTA

Prevalence and Outcomes of Hormone Therapy Use Among Menopausal Women With Inflammatory Bowel Disease (ACG 2026) - "However, patients with CD prescribed systemic HT had higher oral prednisone use, while osteoporosis/fracture outcomes were lower among patients receiving systemic HT. Figure: 1-Systemic non-transdermal HRT included oral estradiol, conjugated estrogens, esterified estrogens, synthetic conjugated estrogens A and B, oral progesterone, oral medroxyprogesterone, conjugated estrogens/bazedoxifene (Duavee), estradiol acetate vaginal ring (Femring), and norethindrone acetate/ethinyl estradiol (Femhrt). 2-Systemic transdermal HRT included estradiol/norethindrone acetate transdermal patch (CombiPatch), estradiol/levonorgestrel transdermal patch (Climara Pro), estradiol transdermal patches (Alora, Climara, Dotti, Estraderm, Lyllana, Minivelle, Vivelle-Dot), estradiol transdermal gel (EstroGel, Divigel), and estradiol transdermal spray (Evamist). 3-Local estrogen therapy included low-dose vaginal estradiol formulations (Estring, Imvexxy, Vagifem, and Yuvafem) and vaginal conjugated..."

Clinical • Cardiovascular • Coronary Artery Disease • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pulmonary Embolism • Respiratory Diseases • Ulcerative Colitis

Cycle-to-cycle Variability of Progesterone in the Endometrium in Patients Undergoing an Euploid Blastocyst Transfer in a Hormone Replacement Therapy (HRT) Cycle (PROMICOFET) (clinicaltrials.gov) - P4 | N=70 | Not yet recruiting | Sponsor: University Hospital, Ghent

New P4 trial

Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Aug 2026 ➔ Nov 2026

HEOR • Trial initiation date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Immune Modulation • Immunology • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

ARESI: Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Nutrindo Ideais Research Center

New P2 trial

HERBRAVEHEART: Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

New P4 trial • Cardiovascular • Cognitive Disorders • Fibrosis • Immunology

HER-MUSCLE: Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Mette Hansen

New trial

Differences in Physiologically Based Pharmacokinetic Predictions between Software Platforms Can Be Clinically Relevant: Cases of Levornestrogel and Ethinylestradiol Concentrations with SIMCYP versus PK-Sim from a User Perspective. (PubMed, Eur J Drug Metab Pharmacokinet) - "These findings show that reproducing physiologically based pharmacokinetic (PBPK) models across platforms requires more than inputting identical/consistent parameters: Platform-specific defaults and algorithms substantially influence outcomes, in particular in case no parameter is optimized with observed data. Beside the key role of the PBPK expert in the adequate use of the respective platforms, our results highlight the importance of observed data used for parameter adjustment, when needed, and the key role of ensuring model fitting performances on well qualified data. From a regulatory perspective, extrapolating model qualification between platforms should be approached cautiously. Transparent reporting of assumptions, platform-specific sensitivity analyses, and enhanced collaboration between developers, users, and regulators are essential to ensure reproducibility and credibility of PBPK applications in high-impact contexts such as drug-drug interaction assessment."

Journal • PK/PD data

Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Washington

HEOR • New P2 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Immune Modulation • Immunology • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

Optimization of transdermal estradiol gel and micronised progesterone for menopausal hormone therapy (ISGE 2026) - "Objective To incorporate Randomized Controlled Trials (RCTs) evidence and identify estradiol serum levels associated with optimal vasomotor symptom relief from a transdermal estradiol (TdL E2) hydro-alcoholic gel formulation (Oestrogel) clinical development trials, and comparing those levels obtained with the estradiol transdermal patch used in Kronos Early Estrogen Prevention Study (KEEPS)...Interventions Daily application of 1.25g and 2.5g TdL E2 gel (Oestrogel) versus a patch delivering 50ug E2/day (Climara) Main Outcomes Measures and Results In the first study (N=216), the daily 1.25g and 2.5g doses of TdL E2 gel reduced moderate to severe hot flash frequency from a baseline of 10.3 to 2.8 ± 3.7 (-73%) and of 10.5 to 2.0 ± 4.2 (-82%), respectively...Conclusions The efficacy of the 2.5 g dose of gel showed consistently better and clinically meaningful efficacy on vasomotor symptoms versus the 1.25 g dose by reaching E2 blood levels of 60 pg/mL...."

Cardiovascular • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Women's Health

Position paper of the expert panel of the Polish Society of Menopause and Andropause on the use of Oestrogel® in menopausal hormone therapy. (PubMed, Prz Menopauzalny) - "Oestrogel® supports dose flexibility and personalisation, allowing treatment to be tailored according to patient needs and guideline-based therapeutic schemes. When combined with micronised progesterone - the gold-standard progestogen for endometrial protection and the preferred option due to its favourable overall safety profile - this form of HRT offers a modern, well-tolerated, and individualised approach to the management of menopausal symptoms and osteoporosis prevention."

Journal • Review • Cardiovascular • Ischemic stroke • Osteoporosis • Rheumatology • Venous Thromboembolism • CRP

Oestrogel HRT regimens prescribed in General Practice. (PubMed, Ulster Med J) - No abstract available

Journal

In Vitro Percutaneous Absorption of Permeation-Enhancing Estrogen Formulations. (PubMed, Pharmaceuticals (Basel)) - "The objective of this in vitro study is to evaluate the percutaneous absorption of compounded estradiol 0.06% and bi-est E3/E2 0.1%/0.06% in aqueous and anhydrous proprietary permeation-enhancing bases, in comparison with the commercially available estradiol transdermal gel (ESTROGel®). The compounded bases facilitated a steady percutaneous absorption of estradiol, without quick peaking or declining, which is one of the desired characteristics in HRT. Compounding pharmacists and practitioners may consider estradiol compounded formulations as a viable option for hormone delivery to patients."

Journal • Preclinical

Changes in menopause-specific quality of life between women with transdermal estradiol versus oral estrogens: results of a randomized controlled trial. (PubMed, Gynecol Endocrinol) - "257 women aged 40-55 years, within three years after their final menstrual period were randomized to receive transdermal oestrogel (t-E2) (n = 128) or oral estradiol valerate (o- E2V) (n = 129; both with micronized progesterone 200 mg for 14 days each month). The decrease of MENQOL scores after treatment showed almost no difference between the two groups (p > 0.05) except the VMS domain which indicated a better result in oral estrogen group after 24 weeks. This study showed that both transdermal and oral estrogens were highly effective in relieving the overall menopausal symptoms for recently-menopausal women, with little difference in treatment efficacy between the two routes."

Clinical • HEOR • Journal

DECLARED-CT: Effects of Menopausal Hormone and GLP-1 Agonist Therapy on Glucose and Energy Homeostasis in Postmenopausal Women (clinicaltrials.gov) - P=N/A | N=96 | Not yet recruiting | Sponsor: Lia Bally

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Estrogen Hormone Products (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: University of Maryland, Baltimore | Trial completion date: Oct 2024 ➔ Mar 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date

How to Tailor Transdermal Menopausal Hormone Therapy (MHT) to our Patients with a Clinically Meaningful Effect (ISGE 2024) - "2.5 g dosage of Estrogel® applied daily was the most effective dose of gel comparable with Climara® patch and 1 and 2 mg E2 oral tablet efficacy. Lower dosages did not appear to adequately relieve symptoms or there was a lag before effects were observed, independently of the route of administration."

Clinical • Pain

Estrogen Hormone Products (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: University of Maryland, Baltimore | Not yet recruiting ➔ Recruiting

Enrollment open

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Estrogen Hormone Products (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: University of Maryland, Baltimore | Initiation date: Oct 2023 ➔ Jan 2024

Trial initiation date

Estrogen Hormone Products (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: University of Maryland, Baltimore | Trial completion date: Aug 2023 ➔ Aug 2024 | Initiation date: Apr 2023 ➔ Aug 2023 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Trial completion date • Trial initiation date • Trial primary completion date

In vitro percutaneous absorption of extemporaneously compounded estradiol formulations (ISID 2023) - "The commercial medication ESTROGel (estradiol 0.06%) was used as positive control...It is demonstrated that estradiol penetrates through the skin upon topical application of aqueous and anhydrous compounded formulations. These results are important evidence to support the effectiveness of cHRT since the in vitro model used has proven to accurately predict in vivo permeation kinetics."

Preclinical

Estrogen Hormone Products (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: University of Maryland, Baltimore | Initiation date: Jan 2023 ➔ Apr 2023

Trial initiation date

Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women. (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Viramal Limited | Trial completion date: Dec 2021 ➔ Apr 2022 | Trial primary completion date: Oct 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date

Management of asymptomatic hypoglycemia with 40% oral dextrose gel in near term at-risk infants to reduce intensive care need and promote breastfeeding. (PubMed, Ital J Pediatr) - "In our population of near term infants, the introduction of 40% oral dextrose gel to the protocol, helped in the safe management of asymptomatic hypoglycemia and, at the same time, implemented breastfeeding."

Journal • Critical care • Hypoglycemia

Oestrogen Treatment for COVID-19 Symptoms (clinicaltrials.gov) - P2; N=2000; Not yet recruiting; Sponsor: Hamad Medical Corporation

New P2 trial • Infectious Disease • Novel Coronavirus Disease