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

Sponsors and Collaborators:	QuatRx Pharmaceuticals Company Hormos Medical
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
Atrophy Vaginal Diseases	Drug: Ospemifene (once daily for 12 weeks)	Phase III

Drug Information available for: Ospemifene

U.S. FDA Resources

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 Outcome Measures:

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 Outcome Measures:

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

Enrollment:	826
Study Start Date:	January 2006
Study Completion Date:	December 2007

Detailed Description:

This study has two extension studies associated with it; both with the purpose of evaluating the long-term safety of ospemifene at varying dosages in postmenopausal women.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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:

Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
Abnormal Pap smear
Uterine bleeding of unknown origin or uterine polyps
Current vaginal infection requiring medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276094

Show 52 Study Locations

Sponsors and Collaborators

QuatRx Pharmaceuticals Company

Hormos Medical

Investigators

Study Director:

Janne Komi, MD, PhD

Hormos Medical

More Information

MedlinePlus Vaginal Diseases Health Topic Site This link exits the ClinicalTrials.gov 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.

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.

Responsible Party:	QuatRx ( Medical Director )
Study ID Numbers:	15-50310
Study First Received:	January 10, 2006
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00276094
Health Authority:	United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:

Vaginal atrophy
Urogenital atrophy
Menopausal symptoms
Vulvar and vaginal atrophy in postmenopausal women

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Genital Diseases, Female
Atrophy
Vaginal Diseases
Menopause

ClinicalTrials.gov processed this record on January 16, 2009