Output Explorer

Table 1 Summary of clinical phase II/Ill studies of Totelle Cycle and comparators
Study
Major endpoints
Treatment arms
Duration
Total
Number
Reference
number
(cycles)
number
evaluable
of
for bleeding
subjects
Phase II
2001
dose-ranging
2 mg E2 + TMG
3
38
14
(0. 10, 0.25 or
0.5 mg)
2002
dose-ranging
+ TMG
5/7
266
13
(0.05, 0. 10, 0.25 or
0.5 mg)
2003
extension of Study
2 mg E2 + 0.25 mg
5/7
134
200'
TMG
Phase III
3001
efficacy, safety
2 mg E2 + 0.25 mg
13/26
163
148
15
( endometrial safety
TMG
in extra 13 cycles
Totelle Cycle
165
153
with 236 subjects
Trisequens
159
145
3003
efficacy, safety
Totelle Cycle
13
320
296
16
Cycloprogynova /Cy
314
296
clocur
300400
hemostasis
Totelle Cycle
6/7
93
67
Femoston
91
72
300200
prevention of
Totelle Cycle
26
241
postmenopause
Femoston
242
227
230
osteoporosis,
efficacy, safety
300500
glucose and
Totelle Cycle
6/7
56
39
insulin metabolism
Placebo
56
n/a
2 mg E2 + 10 mg
58
36
MPA
1 .
All studies were carried out in a double-blind, randomized, multicenter parallel-
group design, with the exception of Study 2003 which was an open multicenter
study. All phase III studies were multinational
2 .
In the phase III studies, a total of 782 and 779 women for Totelle Cycle and all
comparators, respectively, were evaluable for bleeding
1 May, 2003
[Page]
Confidential Pursuant to Confidentiality
Produced for use in NJ HRT litigation.
DUBIDO02-007519
Order

Answer the question using only the OCR text from a single document page. Return only the answer, with no explanation. Preserve the answer wording from the OCR text when possible.