A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women.

Author(s): Gast MJ, Freedman MA, Vieweg AJ, De Melo NR, Girao MJ, Zinaman MJ, the Dyspareunia Study Group

Affiliation(s): From the 1Wyeth Pharmaceuticals, Collegeville, PA; 2Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta, GA; 3Instituto de Saude e Ben-Estar da Mulher, Sao Paulo, Brazil; 4Department of Gynaecology, Federal University, Sao Paulo, Brazil; and 5Department of Obstetrics and Gynecology, Loyola University of Chicago, Maywood, IL.

Publication date & source: 2008-11-20, Menopause., [Epub ahead of print]

Publication type:

OBJECTIVE:: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women. DESIGN:: This outpatient, double-blind, randomized, placebo-controlled trial enrolled 285 healthy, sexually active postmenopausal women aged 45 to 65 years. Women received either one daily oral low-dose conjugated estrogens (0.45 mg)/medroxyprogesterone (1.5 mg) tablet for six 28-day cycles along with 1 g conjugated estrogens vaginal cream (0.625 mg), intravaginally for the first 6 weeks of the trial or a placebo cream and placebo tablet. Efficacy was evaluated using the McCoy Female Sexuality Questionnaire, self-reported daily diary cards, the Brief Index of Sexual Functioning-Women (BISF-W), and the Women's Health Questionnaire. RESULTS:: The EPT group had a significant decrease in the frequency of dyspareunia compared with baseline and placebo in an analysis of responses to the McCoy Female Sexuality Questionnaire. Also, EPT was associated with a significant improvement in a woman's level of sexual interest, frequency of orgasm, and pleasure of orgasm. There was no effect of EPT use on coital frequency. The EPT group had significant improvement in receptivity/initiation and relationship satisfaction, although not in other BISF-W domains, versus placebo (BISF-W analysis) and significant improvement versus placebo on most Women's Health Questionnaire responses. CONCLUSIONS:: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.