Clinical Research Directory

Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy

Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus. The purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone. This prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period. The results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.

Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women. 2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.