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


METHODS
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.
Gast
Michael J
MJ
Wyeth Pharmaceuticals, Collegeville, PA, USA.
Freedman
Murray A
MA
Vieweg
Alberta J
AJ
De Melo
Nilson R
NR
Girão
Manoel J B C
MJ
Zinaman
Michael J
MJ
D000282:Administration, Intravaginal; D004311:Double-Blind Method; D004338:Drug Combinations; D004414:Dyspareunia / Q000188:drug therapy*; D004967:Estrogens / Q000008:administration & dosage*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008525:Medroxyprogesterone / Q000008:administration & dosage; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects*; D011372:Progestins / Q000008:administration & dosage; D011788:Quality of Life; D016896:Treatment Outcome
D004338:Drug Combinations; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D011372:Progestins; D008525:Medroxyprogesterone