A Clinical Study to Evaluate the Safety of Ospemifene - Tabular View

Tracking Information
First Received Date ^ICMJE	November 30, 2007
Last Updated Date	July 10, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 3, 2008)	Mean change from baseline in percentage of parabasal cells in maturation index of vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Mean change in percentage of superficial cells in maturation index of vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Mean change from baseline in vaginal pH [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: November 30, 2007)	Mean change from baseline in percentage of parabasal cells in maturation index of vaginal smear [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Mean change in percentage of superficial cells in maturation index of vaginal smear [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Mean change from baseline in vaginal pH [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00566982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 30, 2007)	Change from baseline in serum hormone levels [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Change from baseline in visual evaluation of the vagina [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Clinical Study to Evaluate the Safety of Ospemifene
Official Title ^ICMJE	Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo
Brief Summary	The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Atrophy Vaginal Diseases
Intervention ^ICMJE	Drug: Ospemifene (orally dosed once daily for 52 weeks) Drug: Placebo
Study Arms / Comparison Groups	Experimental: 60mg dose Placebo Comparator: Placebo
Publications *	Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician. 2000 May 15;61(10):3090-6. 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. Greendale GA, Judd HL. The menopause: health implications and clinical management. J Am Geriatr Soc. 1993 Apr;41(4):426-36. Review. 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. [No authors listed] Breast cancer and hormone replacement therapy: collaborative reanalysis of data from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Collaborative Group on Hormonal Factors in Breast Cancer. Lancet. 1997 Oct 11;350(9084):1047-59. Erratum in: Lancet 1997 Nov 15;350(9089):1484. Grady D, Gebretsadik T, Kerlikowske K, Ernster V, Petitti D. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Obstet Gynecol. 1995 Feb;85(2):304-13. [No authors listed] Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. North American Menopause Society. Estrogen and progestogen use in peri- and postmenopausal women: March 2007 position statement of The North American Menopause Society. Menopause. 2007 Mar-Apr;14(2):168-82. Doyle H. Effective topical treatments for atrophic vaginitis. JAAPA. 2006 Oct;19(10):33-8. No abstract available.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	350
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Naturally or surgically menopausal Intact uterus Vaginal pH greater than 5.0 5% or fewer superficial cells in maturation index of vaginal smear Exclusion Criteria: Evidence of endometrial hyperplasia, cancer or other pathology Abnormal Pap smear Uterine bleeding of unknown origin or uterine polyps Current vaginal infection requiring medication Use of hormonal medications Clinically significant abnormal gynecological findings other than signs of vaginal atrophy
Gender	Female
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Denmark, Finland, Sweden

Administrative Information
NCT ID ^ICMJE	NCT00566982
Responsible Party	Hormos Medical Ltd, Hormos Medical Ltd / Quatrx Pharmaceuticals Co.
Study ID Numbers ^ICMJE	15-50718
Study Sponsor ^ICMJE	QuatRx Pharmaceuticals Company
Collaborators ^ICMJE	Hormos Medical Ltd.
Investigators ^ICMJE
Information Provided By	QuatRx Pharmaceuticals Company
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP