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Trimegestone - Publication and Abstract Tracking Report
7/17/2003
II.
Manuscripts - Totelle Cycle 1 mg
Authors
Priority |Article title
Stage
Journal Timing
Status
Genazzani A
Paper PS(1)
Phase III Maturitas July/August First draft submitted for initial review August 8
AR,
A study of the control of climacteric
2003 journal Comments received from Daniele December 7
Gambaccia
symptoms in postmenopausal women
submission Revised draft submitted January 9
ni M,
following sequential regimens of 1mg
Comments received from Richie, February 28
Spielmann
D, and the
estradiol and trimegestone compared with
Needs major revisions because of inclusion of non-marketed
a regimen containing estradiol and
formulation
Trimegest
norethisterone over a period of 2 years
(3-7-03) Danielle needs to get comments to them, before can
one 301
update. Parthenon to continue through to publication.
Study
(5-7-03) Needs to be circulated for final review and sign off ready
Group
for journal submission
5-29-03) Circulated for review to Linda, Daniele, Richie and Sophie
(7-10-03) Being updated by Parthenon, a quick review by the team
then out to external authors for final review.
Koninckx
A
Paper PS(2)
Phase III Menopausaly 2003
First draft submitted for initial review August 9
,
A comparative 2-year study of the effects
e
journa
Comments received from Daniele December 7
Spielmann
of sequential regimens of 1 mg estradiol
submission Revised draft submitted January 13
D, and
and trimegestone with a regimen
Comments received from Richie February 28
The
containing estradiol and norethisterone
Needs major revisions because of inclusion of non-marketed
Trimegest
formulation
one 302
upon the patterns of endometrial bleeding
and safety in postmenopausal women
(3-7-03) Sophie has sent comments (but Parthenon do not have),
Stud
but waiting for Danielle's comments - week after next. Dave to
Group
forward Sophie's comments to Parthenon. Parthenon to continue
through to publication
(5-7-03) Needs to be circulated for final review and for Sophie to
include the new bleeding data analysis; then do sign off ready for
journal submission
(5-30-03) Circulated for review to Linda, Daniele, Richie and Sophie
(7-10-03) Being updated by Parthenon, a quick review by the team
and then out to external authors for final review.
TBD
C
Paper PS(3)
Phase III TBD
Q4 2003
First draft submitted for initial review April 19, 2002
Metabolic and hemostatic profile of
journal
Comments received from Gary May 13
postmenopausal women receiving a
submission Revised draft in preparation
combined sequential regimen of either
3-7-03) This has not progressed that far. Gary has made
1mg estradiol and trimegestone or
comments. Need to forward all to Dave for DW to take over.
estradiol and norethisterone over a 1-year
Passed over to DW
period
7-10-03) Needs to be updated post-WHI, but is a low-priority
paper
Page 3 of 13
Design Write, Inc.
Confidential Pursuant to Confidentiality Order
WINNR201-013978
Source: https://www.industrydocuments.ucsf.edu/docs/yxvw0217

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