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PROGRESS REPORT 33
Totelle 2mg
Client: Wyeth-Ayerst
March 20, 2002
PROJECT
CLASSIFICATION
TARGET
STATUS / ACTION
PUBLICATION
DATE/JOURNAL
P3(1.1) FAST TRACK
Metabolic
1Q2002
Blood lipid profile o
Sign off received from Wyeth. Dr Al-Azzawi agreed to act
impact/hemostasis
Gynecological
as named author. He suggested the addition of Dr J.
postmenopausal women receiving
Endocrinology
Stevenson since he had been a co-worker on the study. Dr
hormone replacement therapies
Stevenson has revised the manuscript and it was returned to
containing estradiol in combination
Dr Al-Azzawi for approval. He has provided his comments
with either norethisterone acetate or
and only final query has to be clarified with J. Stevenson
trimegestone over a 1-year period
before submission to Wyeth for final sign-off
P3(2)
Bone
2Q2002
Comments received from Gary Grubb 18.03.02. Revisions
A comparison of two hormone
being carried out.
replacement therapies containing
estradiol in combination with either
dydrogesterone or trimegestone with
respect to prevention of
postmenopausal bone loss
P3(3) FAST TRACK
Efficacy
Published
A 1-year comparison of the efficacy
Gynecological Endocrinology 2001;15:349-58
and clinical tolerance in
postmenopausal women of two
hormone replacement therapies
containing estradiol in combination
with either norgestrel or
trimegestone
Meuwissen J.H.J.M. et al.
P3(4)a
Metabolic
Paper to be prepared by Hellgren and Kluft
Effects of an es
impact/hemostasis
Am J Obstet
combination in comparison wit
Gynecol
Femoston on cardiovascular risk
factors (factor VII, fibrinogen, PAI-
1, t-PA, glucose, lipids
P3(4)1
Metabolic
Paper to be prepared by Norris
Effects of an estradiol/trimegestone
impact/hemostasis
Thrombosis
combination in comparison with
Haemostasis
Femoston on other coagulation
parameters (inhibitory factors,
markers of balance between
activation of coagulation and
fibrinolysis)
P3(5)
Metabolic
2Q2002
Parthenon request supply of data so that preparation of the
Single center, randomized, double-
impact/hemostasis
draft manuscript can begin
blind study of the effects of the
estradiol (2mg)
trimegestone (0.5mg) combination in
comparison with a placebo and an
estradiol
(2mg)/medroxyprogesterone acetate
(MPA) (10mg) combination on
glucose and insulin metabolism
during 6 months of treatment
P3(6) FAST TRACK
2Q2002
Assessment of the metabolic
Metabolic
tolerance in postmenopausal women
impact/hemostasis
Gynecological
Accepted for publication in April issue of Gynecological
Endocrinology
Endocrinology
over a 1-year period of two hormone
replacement therapies containing
estradiol in combination with either
norgestrel or trimegestone
P3(7) FAST TRACK
Bleeding profile
302002
Parthenon request supply of data so that preparation of the
Meta-analysis of phase III studies on
draft manuscript can begin
bleeding pattern data
P3(8
Metabolism
3Q2002
Title and paper in preparation
Glucose and insulin metabolism
Samsioe G.
N
Confidential Pursuant to Confidentiality
CONTA025-023032
Order
Source: https://www.industrydocuments.ucsf.edu/docs/lkvw0217

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