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A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women - Article


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Spinal and bulbar muscular atrophy

Bulbospinal muscular atrophy, X-linked; KD; Kennedy disease; Kennedy spinal and bulbar muscular atrophy; SBMA 



Clinical Trial: A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

This study is not yet open for patient recruitment.
Verified by QuatRx Pharmaceuticals Company January 2006

Sponsors and Collaborators: QuatRx Pharmaceuticals Company
Hormos Medical Corporation
Information provided by: QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier: NCT00276094

Purpose

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.
Condition Intervention Phase
Vulvar and Vaginal Atrophy in Postmenopausal Women
  Drug: Ospemifene once daily for 12 weeks
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

Further study details as provided by QuatRx Pharmaceuticals Company:
Primary Outcomes: Mean change from baseline in the VVA symptom identified by the patient to be most bothersome; Mean change from baseline in vaginal pH; Mean change from baseline in number of parabasal cells in maturation index of vaginal smear; Mean change from baseline in number of superficial cells in maturation index of vaginal smear
Secondary Outcomes: Change from baseline in visual evaluation of the vagina; Change from baseline in VVA symptoms; Change from baseline in serum hormone levels; Change from baseline in urinary symptoms
Expected Total Enrollment:  795

Study start: February 2006
Last follow-up: December 2006

Eligibility

Ages Eligible for Study:  50 Years   -   80 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  • Naturally or surgically postmenopausal
  • Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
  • Vaginal pH greater than 5.0
  • 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00276094


Alabama
      Clinical Research Site, Mobile,  Alabama,  36608,  United States

Study chairs or principal investigators

Janne Komi, MD, PhD,  Study Director,  Hormos Medical Corporation   

More Information

MedlinePlus Vaginal Diseases Health Topic Site

Publications

Willhite LA, O''''Connell MB. Urogenital atrophy: prevention and treatment. Pharmacotherapy. 2001 Apr;21(4):464-80. Review.

Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and atrophic vaginitis. Am J Med Sci. 1997 Oct;314(4):228-31. Review.

Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician. 2000 May 15;61(10):3090-6.

Iosif CS, Batra S, Ek A, Astedt B. Estrogen receptors in the human female lower uninary tract. Am J Obstet Gynecol. 1981 Dec 1;141(7):817-20.

Cardozo L, Bachmann G, McClish D, Fonda D, Birgerson L. Meta-analysis of estrogen therapy in the management of urogenital atrophy in postmenopausal women: second report of the Hormones and Urogenital Therapy Committee. Obstet Gynecol. 1998 Oct;92(4 Pt 2):722-7.

Berg G, Gottwall T, Hammar M, Lindgren R. Climacteric symptoms among women aged 60-62 in Linkoping, Sweden, in 1986. Maturitas. 1988 Oct;10(3):193-9. Erratum in: Maturitas 1988 Dec;10(4):363. Gottgall T [corrected to Gottwall T].

Rekers H, Drogendijk AC, Valkenburg HA, Riphagen F. The menopause, urinary incontinence and other symptoms of the genito-urinary tract. Maturitas. 1992 Oct;15(2):101-11.

Molander U, Milsom I, Ekelund P, Mellstrom D, Eriksson O. Effect of oral oestriol on vaginal flora and cytology and urogenital symptoms in the post-menopause. Maturitas. 1990 Jun;12(2):113-20.

Henriksson L, Stjernquist M, Boquist L, Cedergren I, Selinus I. A one-year multicenter study of efficacy and safety of a continuous, low-dose, estradiol-releasing vaginal ring (Estring) in postmenopausal women with symptoms and signs of urogenital aging. Am J Obstet Gynecol. 1996 Jan;174(1 Pt 1):85-92.

Milsom I, Arvidsson L, Ekelund P, Molander U, Eriksson O. Factors influencing vaginal cytology, pH and bacterial flora in elderly women. Acta Obstet Gynecol Scand. 1993 May;72(4):286-91.

Study ID Numbers:  15-50310
Last Updated:  January 11, 2006
Record first received:  January 10, 2006
ClinicalTrials.gov Identifier:  NCT00276094
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17


Source: ClinicalTrials.gov
Cache Date: January 18, 2006

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