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Local estrogen treatment in patients with urogenital symptoms
Author(s) -
Šimunić V,
Banović I,
Ciglar S,
Jeren L,
Pavičić Baldani D,
Šprem M
Publication year - 2003
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/s0020-7292(03)00200-5
Subject(s) - medicine , placebo , vaginal atrophy , genitourinary system , urination , urology , estrogen , atrophy , urinary system , gynecology , alternative medicine , pathology
Objectives: Determination of the efficacy and safety of vaginally administered low dose (25 μg) micronized 17 β ‐estradiol in the management of patients with urogenital symptoms. Methods: A total of 1612 patients with urogenital complaints were randomized to receive 25 μg of micronized 17 β ‐estradiol ( n =828) or placebo ( n =784) in a multicenter double‐blind placebo‐controlled study running for 12 months. Female patients were treated once a day over a period of 2 weeks, and then twice a week for the remaining of the 12 months with an active or placebo tablet. The assessment included full history‐questionnaire, micturition diary, gynecologic and cystometric examination, transvaginal ultrasound, and serum 17 β ‐estradiol level determination. It was carried out at the beginning, and after 4 and 12 months of treatment. Results : The overall success rate of micronized 17 β ‐estradiol and placebo on subjective and objective symptoms of postmenopausal women with vaginal atrophy was 85.5%, and 41.4%, respectively. A significant improvement of urinary atrophy symptoms was determined in vaginal ERT group as compared with the beginning of the study (51.9% vs. 15.5%, P =0.001). The maximal cystometric capacity (290 ml vs. 200 ml, P =0.023), the volume of the urinary bladder at which patients first felt urgency (180 vs. 140, P =0.048), and strong desire to void (170 ml vs. 130 ml, P =0.045) were significantly increased subsequent to the micronized 17 β ‐estradiol treatment. The number of patients with uninhibited bladder contractions significantly decreased following micronized 17 β ‐estradiol as compared with pretreatment values (17/30, P =0.013). Side effects were observed in 61 (7.8%) patients treated with low dose micronized 17 β ‐estradiol. Therapy with 25 μg of micronized 17 β ‐estradiol did not raise serum estrogen level nor stimulated endometrial growth. Conclusions: Local administration of 25 μg of micronized 17 β ‐estradiol is an effective and a safe treatment option in the management of women with urogenital complaints.