Source: DGNews  |  Posted 8 years ago

By Jerry Ingram

MIAMI BEACH, FL -- October 3, 2003 -- Treatment with conjugated oestrogens and the norpregnane progestin trimegestone results in significant improvement in quality of life for postmenopausal women, according to a large clinical trial supported by Wyeth Research here September 21st at the Annual Meeting of the North American Menopause Society (NAMS).

"In this particular study, a new progestin is being looked at together with an old oestrogen," said Wulf Utian, MD, PhD, lead researcher and Executive Director/Honorary Founding President of NAMS. "We are now moving beyond the issues of pure symptom relief to trying to see what the impact is [on] quality of life. The value of this study is that it showed that there are differences clearly. Here's a progestin that did not attenuate the oestrogen effect, as previously shown, on a quality of life. You have a progestin that on most of the parameters here had a benefit."

For this double-blind, placebo controlled trial, investigators enrolled 1,655 healthy, postmenopausal women from multiple study centers. The women were between the ages of 40 and 65 and received 1 of 5 oral regimens of continuous combined or sequential conjugated oestrogens plus trimegestone (CO/TMG) or placebo. Treatment continued for a 1 year period consisting of thirteen 28-day cycles. The two continuous combined regimens were OE 0.625 mg plus TMG 0.0625 or 0.125 mg. The two sequential regimens were OE 0.625 mg on days 1-28 plus TMG 0.125 or 0.250 mg on days 17-28. Results were presented at the 14th Annual Meeting of the North American Menopause Society.

The investigators assessed patients' quality of life using the Women's Health Questionnaire (WHQ). All of the groups of patients taking OE/TMG had a significantly greater improvement than those on placebo in terms of vasomotor symptoms, sleep difficulty, physiological symptoms, memory concentration, sexual behavior and attractiveness (p<0.05). However, depressed mood and anxiety or fear related symptoms were not impacted by OE/TMG therapy.

Patients receiving OE/TMG had significant improvements (p<0.05) from baseline in all domains of the WHQ, except for attractiveness. The menstrual symptoms subscale scores increased significantly (p<0.05) in the OE/TMG groups in comparison with baseline and with the placebo group, indicating a less favourable assessment of therapy. However, these differences diminished over time.

On the whole, postmenopausal women in this study faired well in six of nine domains of WHQ when compared with placebo, the researchers concluded.

[Study title: The Impact of Conjugated Estrogens (CE)/Trimegestone (TMG) on Health-Related Quality of Life (QoL) in a Double-Blind, Randomized, Placebo-Controlled Study. Abstract P123]