Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy.
OBJECTIVE
To determine if the efficacy of continuous low dose estradiol released from a vaginal ring is equivalent to estriol vaginal cream regarding improvement of the patient's subjective feeling of vaginal dryness and to determine if there is a preference for either of the two study treatments.


METHODS
Open-label randomized parallel group trial with active control with a blind evaluation of vaginal cytology and with a cross-over (change-over) phase for preference comparison. One hundred and sixty five postmenopausal women with symptoms of vaginal dryness and signs of vaginal atrophy were randomized to an estradiol ring (Estring) or estriol cream (Synapause). The duration of each treatment period was 12 weeks.


RESULTS
Both study treatments were equally effective regarding the ability to alleviate the symptom feeling of vaginal dryness and the signs of vaginal atrophy. Both treatments were efficient in restoring the vaginal mucosa, recorded as higher maturation values and as decreased vaginal pH. Estring was superior to estriol cream regarding preference of treatment. Both treatments were equivalent for the occurrence of adverse events, including bleeding.


CONCLUSIONS
data from this change-over study confirm efficacy and safety of both the vaginal ring and cream in the treatment of postmenopausal women with urogenital atrophy symptoms and signs. The patients had a strong preference for the vaginal ring.
Barentsen
R
R
Department of Obstetrics and Gynecology, Elkerliek Hospital, Helmond, The Netherlands.
van de Weijer
P H
PH
Schram
J H
JH
D000282:Administration, Intravaginal; D001284:Atrophy; D018592:Cross-Over Studies; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004964:Estriol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology; D017060:Patient Satisfaction; D017698:Postmenopause; D014621:Vagina / Q000473:pathology*; D014622:Vaginal Creams, Foams, and Jellies
D014622:Vaginal Creams, Foams, and Jellies; D004958:Estradiol; D004964:Estriol