Vagifem (estradiol) / Novo Nordisk - 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

IDEAL: Improving Diagnostics in Cervical Dysplasia (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: University of Aarhus | Trial completion date: Jul 2025 ➔ Aug 2026 | Trial primary completion date: Jun 2025 ➔ Aug 2026

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

VEMORA: Vaginal Estrogen versus non-hormonal MOisturizer in women Receiving Aromatase inhibitors: a randomized, controlled trial. (PubMed, Breast Cancer Res Treat) - "In this randomized study, vaginal estrogen provided greater improvement in vaginal dryness and dyspareunia than non-hormonal therapy in breast cancer survivors. These findings provide prospective evidence supporting symptomatic benefit with minimal systemic estrogen exposure in most patients, although larger studies with longer follow up are needed to define long-term safety and efficacy."

Clinical • Journal • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Vaginal Cancer • Women's Health

Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV (clinicaltrials.gov) - P4 | N=62 | Not yet recruiting | Sponsor: Albert Einstein College of Medicine | Trial completion date: Jun 2031 ➔ Oct 2029 | Initiation date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Jun 2031 ➔ Sep 2029

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

Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV (clinicaltrials.gov) - P4 | N=62 | Not yet recruiting | Sponsor: Albert Einstein College of Medicine

New P4 trial • Gynecology • Human Immunodeficiency Virus • Infectious Disease • Vaginal Atrophy • Vaginitis • Women's Health

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Polly A. Niravath, MD | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections (clinicaltrials.gov) - P4 | N=111 | Active, not recruiting | Sponsor: University of California, Irvine | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2027 ➔ Jun 2027

Enrollment closed • Trial primary completion date • Infectious Disease • Nephrology

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Polly A. Niravath, MD | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial primary completion date • Breast Cancer • Estrogen Receptor Positive 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 | Trial completion date: Jul 2026 ➔ Dec 2026

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

Trends in Prescription Cost Savings for Vaginal Estrogen. (PubMed, Urogynecology (Phila)) - "While significant price variations for prescriptions were seen on a regional level within zip codes and between pharmacies, notable price savings were consistently seen with CPD and GoodRx, offering a solution to the financial strain that these prescriptions may impose."

HEOR • Journal • Women's Health

Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: Tel-Aviv Sourasky Medical Center

New trial • CNS Disorders • PROS1

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