A multicenter, open-label study to evaluate satisfaction and menopausal quality of life in women using transdermal estradiol/norethindrone acetate therapy for the management of menopausal signs and symptoms.
Author(s): Adler G, Young D, Galant R, Quinn L, Witchger MS, Maki KC
Affiliation(s): Florida GYN Group, Orlando, Florida, USA.
Publication date & source: 2005, Gynecol Obstet Invest., 59(4):212-9. Epub 2005 Mar 7.
Publication type: Clinical Trial; Multicenter Study
AIM: This multicenter, open-label, single-arm study evaluated subject satisfaction and improvements in menopausal quality of life among menopausal women using the CombiPatch transdermal system consisting of 17beta-estradiol 0.05 mg plus norethindrone acetate 0.14 mg in a matrix patch formulation. METHODS: The 193 postmenopausal women between the ages of 45 and 65 years who comprised the modified intent-to-treat population (at least one patch and one efficacy assessment) were required to have reported at least five daily moderate-to-severe hot flashes and episodes of nocturnal sweating upon study entry for at least 1 month and applied one patch twice a week for 12 weeks. At weeks 0, 6, and 12, the women completed the Menopause-Specific Quality of Life (MENQOL) Questionnaire and, as a secondary study outcome, reported the scale of their application site discomfort. During weeks 1-12, they also kept diary records of number and severity of hot flashes and four other menopausal symptoms. Skin tolerance and adherence of the transdermal system were evaluated at weeks 6 and 12 by qualified evaluators. At week 6 and the end of the study, both subjects and physicians rated their satisfaction with the system. RESULTS: Among women in the modified intent-to-treat population, transdermal 17beta-estradiol plus norethindrone acetate significantly reduced the mean daily number of moderate-to-severe hot flashes experienced by women from 4.1 at week 1 to 0.6 at week 12 (p < 0.0001). The mean ratings of headache severity, insomnia, and vaginal irritation/dryness also improved significantly by week 6 and were maintained at week 12. At week 12, 92.4% of the subjects and 97.3% of the physicians reported that they were 'satisfied' or 'very satisfied' with the transdermal hormone delivery system. CONCLUSIONS: The results of this study compare favorably with previous placebo-controlled studies of transdermal hormone therapy in managing menopausal signs and symptoms. Furthermore, quality of life was significantly improved by the transdermal hormone therapy system, and both subjects and physicians reported high levels of satisfaction. Copyright 2005 S. Karger AG, Basel