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PROGRESS REPORT
Trimegestone (1mg)
PROJECT
TARGET DATE CURRENT STATUS / COMMENTS
NEXT ACTION
PHASE 1 PROTOCOLS
0915A3-101/10
Trials are comple
Awaiting final data
A single-dose, comparative
bioavailability study of a single
No scientific interest
combination-tablet formulation
conjugated estrogen/
trimegestone (0.625mg/ 0.25mg
or 0.0625mg vs Premarin tablet
(0.625mg))
0915A3-105
Trial is complete.
Awaiting final data. pK report
The effects of food on the
Interest in publication depends on data
expected 07.99. Follow-up with J.
pharmacokinetics of
Ermer
combination tablets of
conjugated estrogens/
trimegestone in healthy
postmenopausal subjects
PHASE 2 PROTOCOL
0915A3-207-CH
Trial is complete. Awaiting final data
Awaiting final data.
A comparative, double-blind,
2Q99). 3-cycle lipid data comparing
Acceptability to publish?
randomized study of the lipid
medroxyprogesterone acetate and
effects of two regimens of
trimegestone in combination with Premarin
Premarin and trimegestone
compared with Premarin and
medroxyprogesterone acetate in
postmenopausal women
PHASE 2 PAP
WP2(1)
1 or 2 papers
Dose ranging study of 3
combinations of 1mg 17BE2
and 3 doses of trimegestone vs
Kliogest. Effect on endometrial
safety, bleeding patterns and
lipid metabolism
WP2(2)
Mid 1999
Abstract received 10.03.99. Publication
In vitro characterization of
outline is being drafted.
trimegestone: a new potent and
selective steroidal progestin
Target journal: J Steroid Biochem Molec
Z. Zhang et al.
Biol
WP2(3)
Mid 1999
Abstract received 10.03.99. Publication
in vivo characterization of
outline is being drafted.
trimegestone: a new potent and
selective steroidal progestin
Target journal: J Steroid Biochem Molec
Biol
S.G. Lunden et al.
WP2(4)
Late 1999/Early
Studies in progress; results due in
The effect trimegestone vs MPA
2000
March/April.
on estradiol antagonism of
Target Journal: none
calcium mobilization in coronary
artery smooth muscle cells
Poster presentation: none planned until
K. Hermsmeyer et al
esuits are r
Confidential Pursuant to Confidentiality
Order
SOLOJ015-000971
Source: https://www.industrydocuments.ucsf.edu/docs/hnvw0217

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