Climara (estradiol) / Bausch Health, Bayer - LARVOL DELTA

Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PGR

Estrogen Supplementation and Bone Health in Women With CF (clinicaltrials.gov) - P4 | N=75 | Recruiting | Sponsor: Johns Hopkins University | Trial completion date: Dec 2025 ➔ Jan 2027 | Trial primary completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

The Case for, and Challenges to, using Transdermal Estradiol for Androgen Deprivation Therapy (AUA 2025) - "The RCT evidence used Femseven and Progynova TS 100 mcg patches initially 4 patches changed twice weekly, then 3 patches twice weekly when testosterone was<1.7 nmol/L. Despite randomized phase III data endorsing tE2 for ADT, PCa patients encounter barriers to accessing tE2. Our data indicate the need for further research on tE2 products to treat PCa. There is currently a strong case for a license extension of products initially developed to treat menopausal symptoms in women."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Washington | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Mar 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Washington | Suspended ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Long-term cognitive effects of menopausal hormone therapy: Findings from the KEEPS Continuation Study. (PubMed, PLoS Med) - P4 | "In these KEEPS Continuation analyses, there were no long-term cognitive effects of short-term exposure to mHT started in early menopause versus placebo. These data provide reassurance about the long-term neurocognitive safety of mHT for symptom management in healthy, recently postmenopausal women, while also suggesting that mHT does not improve or preserve cognitive function in this population."

Clinical • Journal • Observational data

CLEAR-3: Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (clinicaltrials.gov) - P4 | N=90 | Completed | Sponsor: University of Illinois at Chicago | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ Aug 2024 | Trial primary completion date: Dec 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Psychiatry • Suicidal Ideation

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Suspended | Sponsor: University of Washington | Recruiting ➔ Suspended

Metastases • Trial suspension • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

CLEAR-3: Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (clinicaltrials.gov) - P4 | N=90 | Active, not recruiting | Sponsor: University of Illinois at Chicago | Recruiting ➔ Active, not recruiting

Enrollment closed • Psychiatry • Suicidal Ideation

Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: Mayo Clinic | Enrolling by invitation ➔ Active, not recruiting | N=38 ➔ 5

Enrollment change • Enrollment closed • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PGR

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=38 | Enrolling by invitation | Sponsor: Mayo Clinic | Trial completion date: Apr 2024 ➔ Jul 2026 | Trial primary completion date: Apr 2024 ➔ Jul 2026

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PGR

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

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Washington | Trial completion date: Mar 2025 ➔ Jun 2026

Metastases • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

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

Journal

Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=38 | Enrolling by invitation | Sponsor: Mayo Clinic | Recruiting ➔ Enrolling by invitation

Enrollment status • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PGR

PEEPS: Examining the Effects of Estradiol on Neural and Molecular Response to Reward (clinicaltrials.gov) - P4 | N=103 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Trial completion date: Dec 2027 ➔ Dec 2026

Trial completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: University of Washington

Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Estrogen Supplementation and Bone Health in Women With CF (clinicaltrials.gov) - P4 | N=75 | Recruiting | Sponsor: Johns Hopkins University

Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

A Gender Affirming Experience: The RNS System Tracking Seizure Frequency During Gender Changing Hormonal Therapy (AES 2023) - "During the process of transitioning from male to female, our patient began receiving a slow-release estrogen through transdermal estradiol patches (Climara 0.05 mg/24 hr) in July 2021. Spironolactone was prescribed in December 2021 and progesterone was added in January 2022. She was switched to intramuscular Estradiol (Delestrogen 5mg) injections every two weeks in June 2022... Our patient’s experience suggests that feminizing hormone therapy may increase seizure frequency. There was an observed increase in RNS detection shortly after estrogen initiation, followed by a delayed increase in clinical seizures after 4-5 months. The increase in RNS detections early with estrogen exposure could enable clinicians to make proactive changes to both antiseizure and hormone treatments to balance the patient’s needs in treatment of both conditions."

CNS Disorders • Epilepsy

Cardiometabolic outcomes in Kronos Early Estrogen Prevention Study continuation: 14-year follow-up of a hormone therapy trial. (PubMed, Menopause) - "There was no evidence of cardiovascular and/or metabolic benefits or adverse effects associated with 4 years use of oral or transdermal forms of hormone therapy by recently menopausal women with good cardiovascular health after 10 years."

Journal • Cardiovascular • Diabetes • Metabolic Disorders

Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Mayo Clinic | Trial primary completion date: Apr 2023 ➔ Apr 2024

Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • PGR

CLEAR-3: Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (clinicaltrials.gov) - P4 | N=90 | Recruiting | Sponsor: University of Illinois at Chicago | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Psychiatry • Suicidal Ideation

Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients (clinicaltrials.gov) - P2 | N=9169 | Completed | Sponsor: Istanbul University - Cerrahpasa (IUC)

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Estrogen Patches for Adolescent and Young Adult Women With Cystic Fibrosis (clinicaltrials.gov) - P4 | N=75 | Recruiting | Sponsor: Johns Hopkins University | Not yet recruiting ➔ Recruiting

Enrollment open • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases