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4.9 Body Weight
In year 1 of the study, the CE/TMG groups had significantly less weight gain than the
placebo group at cycles 6 and 9 (p<0.05) for the continuous combined groups and at
3,6 and 9 for the sequential groups (p<0.01).
CHANGES IN BODY WEIGHT
--CE/TMG 0.0625 (CC) vs P
--CE/TMG 0. 125 (SEQ) vs Placebo ---
Adjusted Mear
Adjusted Mean
Cycle
Difference
SEM
p-Values
Difference
SEM
p-Values
-0.01
0.18
0.97
.0.01
0.18
0.094
0.57
0.25
0.020*
0.70
0.24
0.004**
13
-0.76
0.29
0.008*
-0.74
0.28
0.009**
-0.44
0.34
0.19
0.89
0.3
0.008**
16
.0.41
0.52
0.43
-1.04
0.52
0.044*
19
0.02
0.55
0.96
0.61
0.54
0.26
22
26
-0.19
0.56
0.74
.0.76
0.55
0.17
0.14
0.58
0.81
0.97
0.58
0.98
a: Adjusted based on a 1-way analysis of covariance. SEM: Standard error of the
adjusted mean
* p < 0.05, ** p < 0.01
4.10 Quality of Life
The influence CE/TMG on quality of life (Qol) was assessed by identifying changes on
the Women's Health Questionnaire (WHQ) and the Medical Outcomes Study Short
Form-36 (SF-36) questionnaire. The WHQ measures the patient's own assessment of
her changes in health and well-being during the menopause transition. The SF-36 is a
generic measure of functioning and well being not related to any specific age or gender
groups.
The analysis indicated that administration of continuous combined CE /TMG 0.0625 mg
and sequential CE /TMG 0.125 mg to postmenopausal women leads to significant
improvements in Qol when compared with placebo. As measured by the WHQ,
improvements were observed in the domains of vasomotor symptoms, sleep problems,
somatic symptoms, memory/concentration, sexual behavior, and attractiveness; no
significant differences were seen for the domains of anxiety/fears and depressed mood.
For the sequential regimens, as with any sequential regimen designed to provide
regular monthly withdrawal bleeding, scores for the menstrual symptoms domain were
less favorable (p < 0.05) compared with the placebo group.
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Source: https://www.industrydocuments.ucsf.edu/docs/yrvw0217

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