Premarin topical (equine conjugated estrogens) / Pfizer - LARVOL DELTA

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Mackay Memorial Hospital | N=100 ➔ 200 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Mackay Memorial Hospital | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Overactive Bladder

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

Efficacy of Combined Pharmacotherapy Versus Solifenacin with Vaginal Estrogen Cream for Women with Detrusor Overactivity (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Mackay Memorial Hospital | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (clinicaltrials.gov) - P=N/A | N=21 | Terminated | Sponsor: Pamela Moalli | N=53 ➔ 21 | Recruiting ➔ Terminated; Insufficient recruitment

Enrollment change • Trial termination

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Mackay Memorial Hospital | N=200 ➔ 300

Enrollment change • Overactive Bladder

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Mackay Memorial Hospital

New P4 trial • Overactive Bladder

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Mackay Memorial Hospital | N=50 ➔ 100

Enrollment change

Establishing a Rationale for Compounding Hormone Replacement Therapy. (PubMed, Int J Pharm Compd) - "Premarin is no longer at the top of the heap, and there are topical, commercial products that contain bioidentical estradiol, and capsules that contain the same progesterone that we use. Our compounding advantage comes from our abilities to prepare unique patient-specific products, and, very importantly, from our growing understanding of hormone receptors; we now know there are two main estrogen receptors, 1) estrogen receptor alpha and 2) estrogen receptor beta, and the growing knowledge base associated with the discovery of estrogen receptor beta is quite significant."

Journal • ER

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Mackay Memorial Hospital

New P4 trial

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

IMPROVE: Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen (clinicaltrials.gov) - P4 | N=206 | Completed | Sponsor: University of Texas Southwestern Medical Center | Active, not recruiting ➔ Completed

Trial completion • Women's Health

Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Fayoum University | Trial completion date: May 2022 ➔ Sep 2023 | Trial primary completion date: Apr 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Gynecology • Vaginal Atrophy • Vaginitis

[VIRTUAL] Improvement in OAB Symptoms After Vaginal Estrogen Therapy Is Associated with Measurable Pelvic Microbiome Changes (AUA 2020) - P=N/A, P4 | "Introduction: Improvement in OAB Symptoms After Vaginal Estrogen Therapy Is Associated with Measurable Pelvic Microbiome Changes Analysis of data from post-menopausal participants in two trials (NCT02524769 and NCT02835846) who chose vaginal estrogen as their primary OAB treatment and used 0.5 grams of Premarin Cream® twice weekly for 12 weeks. The mechanism of OAB symptom relief following vaginal estrogen use may relate to decreased microbial diversity. Following treatment, microbiota characteristics are more similar to a pre-menopausal state. Source of Funding: This study was funded by Loyola Urogynecology Division Research Fund, an Investigator Initiated grant from the Kimberly Clark Corporation, two NIH awards to Drs."

Late-breaking abstract • Gynecology

Postmenopausal Pessary Users: Estrogen Versus Trimosan (clinicaltrials.gov) - P4 | N=4 | Terminated | Sponsor: The University of Texas Health Science Center, Houston | N=34 ➔ 4 | Recruiting ➔ Terminated; Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel

Enrollment change • Trial termination • Vaginitis

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (clinicaltrials.gov) - P=N/A | N=53 | Recruiting | Sponsor: Pamela Moalli | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date

A multicenter, randomized, open, controlled trial to evaluate the efficacy of Honglilai Vaginal Cream and Premarin Vaginal Cream for Genitourinary Syndrome of Menopause in different subgroups of Chinese postmenopausal women. (PubMed, Gynecol Endocrinol) - "There were no significant differences of Vaginal symptom scores between Honglilai group and Premarin group in every sub-group (p > .05). Honglilai Vaginal Cream had comparable efficacy with Premarin Vaginal Cream in Chinese women older than 60 years."

Journal • Women's Health

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (clinicaltrials.gov) - P=N/A | N=53 | Recruiting | Sponsor: Pamela Moalli | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date

Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Fayoum University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gynecology • Vaginal Atrophy • Vaginitis

Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Fayoum University

Clinical • New P1 trial • Gynecology • Vaginal Atrophy • Vaginitis

FUM: Investigation of the Effect of the Female Urinary Microbiome on Incontinence (clinicaltrials.gov) - P4; N=35; Completed; Sponsor: Loyola University; N=64 ➔ 35

Enrollment change • Overactive Bladder • Urinary Incontinence

"Summer 2022- Premarin Cream" (@SteveShaver4)

IMPLORE: Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy (clinicaltrials.gov) - P4; N=25; Completed; Sponsor: University of Alabama at Birmingham; Recruiting ➔ Completed

Clinical • Trial completion • Gynecology • Urology • Vaginal Atrophy • Vaginitis • CSF2 • CXCL8 • IL10 • IL1B • IL4 • IL6 • TNFA

Vaginal and Urinary Microbiome Trial (clinicaltrials.gov) - P4; N=110; Completed; Sponsor: University of Louisville; Recruiting ➔ Completed

Clinical • Trial completion • Gynecology • Infectious Disease • Nephrology • Vaginal Atrophy • Vaginitis

Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse (clinicaltrials.gov) - P=N/A; N=53; Recruiting; Sponsor: Pamela Moalli; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date