Vagifem (estradiol) / Novo Nordisk - LARVOL DELTA

From waste to wellness - what women want: insights into patient perspectives on topical vaginal estrogen applicators and environmental considerations. (PubMed, Climacteric) - "Manufacturers of health products and prescribers should be aware of this growing trend. With similar overall satisfaction and side-effect profiles, users should be made aware of the different types of applicators available to help support an informed decision."

Journal

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

OVGUS: A study examining the use oestradiol vaginal tablets (Vagifem Low) to treat genitourinary symptoms in women on adjuvant aromatase inhibitors for breast cancer (ANZCTR) - P2 | N=60 | Active, not recruiting | Sponsor: University of Sydney | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor • Vaginal Atrophy • Women's Health

Bilateral Ovarian Agenesis and Bone Modeling Disease in Pre-puberty Girl With Primary Amenorrhea. (PubMed, Cureus) - "Treatment included hormonal therapy with progyluton and estrofem, transitioning to marvilon, alongside physical therapy, nutritional support, and psychological counseling. This is the first reported case of bilateral ovarian agenesis with chromosome X translocation presenting with phenotypic amenorrhea and bone deformities, demonstrating the value of tailored therapeutic approaches. Ongoing monitoring remains essential to ensure continued progress and mitigate long-term risks."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pain • Rheumatology • Women's Health

IDEAL: Improving Diagnostics in Cervical Dysplasia (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: University of Aarhus | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2025 ➔ Jul 2025 | Trial primary completion date: Nov 2024 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Cervical Cancer • Gynecology • Oncology • Solid Tumor

Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women (clinicaltrials.gov) - P4 | N=86 | Completed | Sponsor: Mahidol University | Active, not recruiting ➔ Completed

Trial completion • Overactive Bladder • Urinary Incontinence • Urology

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

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

Determining Dose Equivalence Between Oral and Transdermal Estrogen Treatment in Women With Turner Syndrome (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Aarhus University Hospital

New P4 trial • Endocrine Disorders • Genetic Disorders • Turners Syndrome

Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women: A Randomized Controlled Study (clinicaltrials.gov) - P4 | N=86 | Active, not recruiting | Sponsor: Mahidol University

New P4 trial • Overactive Bladder • Urinary Incontinence • Urology

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

Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study). (PubMed, BMJ Open) - P=N/A, P4 | "A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy...Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences. NCT05283421."

Clinical protocol • Journal • Cervical Cancer • Gynecologic Cancers • Gynecology • 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

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ May 2024 | Trial primary completion date: Sep 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Gynecology • Oncology • Solid Tumor • Vaginal Atrophy • Vaginitis

Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections (clinicaltrials.gov) - P4 | N=111 | Recruiting | Sponsor: University of California, Irvine

Adherence • New P4 trial • Infectious Disease • Nephrology

Vaginal Estrogen Prescribing and Cost Trends Among Medicare Part D Beneficiaries. (PubMed, Urogynecology (Phila)) - "Vaginal estrogen claims, beneficiaries, and total expenditures across all provider types have decreased from 2016 to 2020. However, spending per beneficiary and VE claims have increased. Our data suggest that utilization and accessibility of vaginal estrogen may be influenced, in part, by cost."

Journal • Medicare • Reimbursement • US reimbursement • Breast Cancer • Obstetrics • 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 | 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

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial (clinicaltrials.gov) - P4 | N=51 | Completed | Sponsor: Albert Einstein College of Medicine | Active, not recruiting ➔ Completed

Trial completion • Gynecology • Human Immunodeficiency Virus • Infectious Disease • Vaginal Atrophy • Vaginitis • Women's Health

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

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Breast Cancer • Gynecology • Oncology • Solid Tumor • Vaginal Atrophy • Vaginitis

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial (clinicaltrials.gov) - P4 | N=51 | Active, not recruiting | Sponsor: Albert Einstein College of Medicine | Recruiting ➔ Active, not recruiting

Enrollment closed • Gynecology • Human Immunodeficiency Virus • Infectious Disease • Vaginal Atrophy • Vaginitis • Women's Health

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