Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women.
OBJECTIVE
To evaluate the safety and efficacy of synthetic conjugated estrogens B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women.


METHODS
Prospective, randomized, multicenter, double-blind, placebo-controlled trial.


METHODS
Forty-two participating sites in the United States.


METHODS
Postmenopausal women with at least one moderate to severe symptom of vaginal atrophy.


METHODS
Daily oral administration, in a randomized, placebo-controlled setting, of SCE-B (0.3 mg) or of placebo for 12 weeks.


METHODS
Mean changes in vaginal maturation index, percentage of parabasal and superficial cells, vaginal pH, and severity of the most bothersome symptom (MBS) between baseline and predetermined time points were assessed. Safety and tolerability were evaluated.


RESULTS
A total of 310 women (mean age, 58.6 y) were enrolled. Synthetic conjugated estrogens B yielded statistically significantly greater differences in vaginal maturation index and vaginal pH from baseline to the end of treatment. Vaginal dryness (44.4%) and pain during intercourse (30.2%) were the symptoms most commonly identified as the MBS. A statistically significant mean reduction in the severity of the MBS was noted for SCE-B. There were no clinically significant differences observed between the two groups for findings related to safety.


CONCLUSIONS
Synthetic conjugated estrogens B (0.3 mg/d) was effective in treating vulvovaginal atrophy in symptomatic postmenopausal women. Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.
Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences, Washington, District of Columbia 20036, USA. simon@jamesasimonmd.com
James A
JA
Simon
Kathleen Z
KZ
Reape
Steve
S
Wininger
Howard
H
Hait
D001284:Atrophy / Q000188:drug therapy; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D015990:Placebo Effect; D017698:Postmenopause / Q000187:drug effects*; D016896:Treatment Outcome; D014481:United States; D014621:Vagina / Q000187:drug effects* / Q000473:pathology*; D014844:Vulva / Q000187:drug effects* / Q000473:pathology*
D004966:Estrogens, Conjugated (USP)