Treatment of urogenital atrophy with low-dose estradiol: Preliminary results

Richard J. Santen, Jo Ann V. Pinkerton, Mark Conaway, Mary Ropka, Lisa Wisniewski, Larry Demers, Karen O. Klein

Research output: Contribution to journalArticle

84 Scopus citations

Abstract

Objective: To determine the lowest dosage of vaginally administered estradiol (E2) that reverses signs and symptoms of urogenital atrophy but does not substantially increase plasma E2 levels. Design: Single-blind, single-arm study to determine the effects of de-escalating doses of vaginal estrogen on symptoms of urogenital atrophy, vaginal pH, and vaginal and urethral cytology. A questionnaire was used to assess subjective vaginal and urethral symptoms. Objective measurements included vaginal and urethral cytology, pH, endometrial biopsy, and 24-h circulating plasma luteinizing hormone, follicle-stimulating hormone (FSH), E2, and estrone levels obtained in a Clinical Research Unit. Circulating E2 levels were assayed with an ultrasensitive yeast bioassay with a detection limit of 0.02 pg/mL. Measurements were obtained over a 24-h period after administration of vehicle alone, on day 1 after the initial vaginal E2 dosage, after 3 weeks of daily E2 administration, and after an additional 9 weeks of twice weekly administration. Results: From the first seven subjects studied at a 10-μg dose of E2, 100% responded according to predefined criteria. Vaginal cytology showed statistical improvement at 3 and 12 weeks. Urethral cytology was statistically improved after 12 weeks. Vaginal pH decreased from postmenopausal to premenopausal levels at both 3 and 12 weeks. Eighty-two percent of symptoms were cured or improved. Endometrium remained atrophic. Circulating E2 levels remained within the postmenopausal range of 3-10 pg/mL. Conclusion: A 10-μg dose of vaginal E2 effectively treated urogenital atrophy in seven women and did not cause endometrial hyperplasia or increase E2 levels.

Original languageEnglish (US)
Pages (from-to)179-187
Number of pages9
JournalMenopause
Volume9
Issue number3
DOIs
StatePublished - Jan 1 2002

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'Treatment of urogenital atrophy with low-dose estradiol: Preliminary results'. Together they form a unique fingerprint.

  • Cite this

    Santen, R. J., Pinkerton, J. A. V., Conaway, M., Ropka, M., Wisniewski, L., Demers, L., & Klein, K. O. (2002). Treatment of urogenital atrophy with low-dose estradiol: Preliminary results. Menopause, 9(3), 179-187. https://doi.org/10.1097/00042192-200205000-00006