The Menopause Hour - Episode #30 The FDA’s New Direction and Evolving Menopause Care
Podcast

The Menopause Hour with Winona: The FDA's New Direction and Evolving Menopause Care - Episode #30

Published: December, 2025

Dr. Cathleen Brown

Featured Physician

Cathleen M. Brown

Host

Madi Baldwin

What changed when the FDA removed its decades-old black box warning on hormone therapy? In Episode #30 of The Menopause Hour with Winona, Dr. Michael Green and Dr. Cathleen Brown opened with exactly that question, answering listener questions live in an Ask the Experts Q&A hosted by Madi Baldwin.

The conversation covered why hormone lab testing doesn't guide treatment decisions, how DHEA and dosage changes can affect symptoms like hot flashes and acne, and when birth control versus HRT makes more sense for perimenopausal symptoms. Dr. Green and Dr. Brown also answered questions on joint pain, tinnitus, and the safe window for starting hormone therapy later in life.

LISTEN TO THE EPISODE

Episode Details

  • Podcast: The Menopause Hour with Winona

  • Episode Number: 30

  • Episode Title: Episode #30: The FDA's New Direction and Evolving Menopause Care

  • Host: Madi Baldwin

  • Featured Physicians: Dr. Cathleen Brown

  • Published Date: December 9, 2025

  • Episode Duration: 59 minutes 46 seconds

  • Format: Menopause Q&A

  • Main Topics: FDA Black Box Warning, Hormone Testing, HRT Safety

About The Menopause Hour with Winona Podcast

The Menopause Hour with Winona is a health and wellness podcast hosted by Winona's Chief Medical Officer, Dr. Michael Green, and Medical Director, Dr. Cathleen Brown. The show addresses common questions about perimenopause and menopause, combining medical expertise with straightforward discussions of symptoms, treatment options, and the science behind the menopause transition.

Episodes include live Q&A sessions, doctor-led conversations, and patient stories. In its live Q&A format, women from Winona's community submitted questions directly to the hosts, creating practical discussions shaped by the concerns women commonly brought to their own doctors.

Visit The Menopause Hour on Buzzsprout.

About This Episode

This live Q&A opened with major news: the FDA removed the decades-old black box warning that had appeared on all estrogen products, including vaginal estrogen, since the Women's Health Initiative study. Dr. Brown and Dr. Green explained how this warning had discouraged both doctors and patients from considering hormone therapy for years, even though it no longer reflected current research, and why its removal is expected to make menopause care more accessible.

From there, listener questions ranged widely: why hormone lab testing doesn't help guide treatment, how to know when a dose needs adjusting, and why birth control pills aren't a substitute for HRT in perimenopause. Dr. Brown and Dr. Green also addressed joint pain, tinnitus, and other less-discussed menopause symptoms, along with the safety window for starting hormone therapy later in life, based on the timing hypothesis from the Women's Health Initiative research.

RSVP here to join our next Menopause Q&A.

Topics Covered

  • The FDA's removal of the black box warning on hormone therapy

  • Why hormone lab testing doesn't help guide menopause treatment

  • Spotting and bleeding changes after starting or missing HRT doses

  • How long women can expect to stay on hormone therapy

  • Why birth control isn't a substitute for HRT in perimenopause

  • Managing acne when adjusting DHEA dosage

  • Supplements to avoid or discuss with a doctor while on HRT

  • Joint pain, back pain, and stiffness linked to declining estrogen

  • Tinnitus and other less-common menopause symptoms

  • New hot flashes or night sweats after adding DHEA

  • Why testosterone isn't currently offered through Winona

  • The safe age window for starting hormone therapy later in life

Key Takeaways

The FDA removed the black box warning because the data no longer supported it

Dr. Brown explained that the black box warning had appeared on all estrogen products for decades, including vaginal estrogen, despite newer research showing hormone therapy is safe for most women. Dr. Green added that the change follows an FDA expert panel and years of data showing the original warning was based on outdated research.

Hormone lab testing still isn't a reliable way to guide treatment

Dr. Brown said lab values don't tell providers how to adjust a woman's dose or which medication will work best, and that neither the Menopause Society nor ACOG recommends routine hormone testing. Dr. Green added that a symptom diary gives far more useful information than a lab report.

Birth control pills carry more risk than HRT, not less

Dr. Green explained that birth control pills use a much higher effective dose of estrogen and progesterone than HRT, and carry a greater risk of blood clots and stroke. He noted that HRT is generally the better option for managing perimenopausal symptoms unless contraception is also needed.

Joint pain and stiffness can improve with hormone therapy

Dr. Brown clarified that declining estrogen affects tendons, ligaments, and joint capsules throughout the body, which can make joint pain and stiffness feel like accelerated aging. She noted that estrogen's anti-inflammatory effects mean many women see meaningful improvement in joint pain after starting HRT.

There's a safe window for starting hormone therapy later in life

Dr. Brown explained that starting hormone therapy is generally safest within 10 years of menopause and before age 60, based on the timing hypothesis from the Women's Health Initiative research. She noted that starting HRT well outside that window, such as at 80, carries more risk than benefit.


Cathleen M. Brown

Dr. Cathleen M. Brown

Obstetrics & Gynecology

Dr. Cathleen Brown is a menopause specialist and physician with Winona. She brings a physician’s perspective to menopause, perimenopause, hormone changes, symptom care, and treatment options during midlife.

At Winona, Dr. Brown helps women better understand symptoms, health history, hormone changes, and when physician-reviewed care may be appropriate.

Meet Dr. Cathleen M. Brown

Watch or Listen to the Episode

Watch the full conversation with Dr. Cathleen M. Brown on
The Menopause Hour with Winona with Madi Baldwin.

Get Physician-Led Menopause Care

Winona helps women access menopause and perimenopause care from home. Start with a short health questionnaire, and a board-certified physician will review your symptoms, health history, and treatment options.

Start Your Visit
lead-banner-woman-holding-mug-mobile