EFTA01734942Set 10
2016-09-1615p5,915w
Trial Populations 4
I. Appropriate Target Population 4
2. Eligibility 5
3. Menopausal Status 5
D. Clinical Outcome Assessment Instruments 6
1. Recall Period 6
2. Format ofData Capture ... which is often, but not always, related to vulvovaginal
46 atrophy (VVA) associated with menopause. VVA symptoms are addressed in a separate
47 guidance?
48
49 Although this guidance discusses ... www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfonnation/Guidancesidefault.htm.
2
EFTA_R1_00015160
EFTA01734946
Contains Nonbinding Recommendations
Draft — Notfor Implementation
73 menopause), psychiatric conditions (such as depression and anxiety), use of medications (such as
74 selective serotonin
https://www.justice.gov/epstein/files/DataSet%2010/EFTA01734942.pdf
EFTA00490658Set 9
2019-02-252p410w
Avrum Bluming, M.: Controversial topic affecting
all women—the role of HRT thin menopause and beyond
Date: Mon, 25 Feb 2019 12:02:59 +0000
Greetings -
Released a new episode ... Avrum
Bluming,...: Controversial topic affecting all women—the role of hormone
replacement therapy through menopause and beyond—the compelling case for
long-term HRT and dispelling the myth that ... polarizing and
confusing topic of hormone replacement therapy for women suffering with
symptoms of menopause. In many ways, the story and history of HRT is in
striking parallel
https://www.justice.gov/epstein/files/DataSet%209/EFTA00490658.pdf
EFTA00620069Set 9
26p10,915w
free testosterone. In women, changes in sex
hormones are most extreme during the peri-menopausal time period, when estrogen and
progesterone cycling reduces, along with absolute levels of all androgens ... especially
plagued by poor design (and poor interpretations)—cases in point: HRT in
post-menopausal women without attention to the mode of estrogen delivery;
use of immediate-release
https://www.justice.gov/epstein/files/DataSet%209/EFTA00620069.pdf