Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity - Tabular View

Tracking Information
First Received Date ^ICMJE	August 4, 2008
Last Updated Date	July 10, 2009
Start Date ^ICMJE	July 2008
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 6, 2008)	Change from baseline to week 12 in percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Change from baseline to week 12 in percentage of superficial cells in the maturation index of the vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Change from baseline to week 12 in vaginal pH. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Change from baseline to week 12 in severity of the most bothersome symptom of vaginal dryness and vaginal pain associated with sexual activity. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00729469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 6, 2008)	Change from baseline in percentage of parabasal cells in the maturation index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Change from baseline in percentage of superficial cells in the maturation index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] Change from baseline in vaginal pH [ Time Frame: Week 4 ] [ Designated as safety issue: No ] Change from baseline in severity of most bothersome symptom of vaginal dryness and vaginal pain associated with sexual activity [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Official Title ^ICMJE	Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women
Brief Summary	The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Atrophy Vaginal Diseases
Intervention ^ICMJE	Drug: Ospemifene Drug: Placebo
Study Arms / Comparison Groups	Placebo Comparator: Placebo comparator Active Comparator: Ospemifene 60 mg dose
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. Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208.
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	750
Estimated Completion Date	August 2009
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Naturally or surgically menopausal Moderate or severe symptoms of vaginal atrophy 5% or fewer superficial cells in maturation index of vaginal smear Vaginal pH greater than 5.0 Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization Exclusion Criteria: Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids Current vaginal infection requiring medication Clinically significant abnormal gynecological findings other thans signs of vaginal atrophy (e.g. uterine or vaginal prolapse of Grade 2 or higher) Previous participation in any other ospemifene study
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	United States

Administrative Information
NCT ID ^ICMJE	NCT00729469
Responsible Party	Quatrx Pharmaceuticals Company, Quatrx Pharmaceuticals Company
Study ID Numbers ^ICMJE	15-50821
Study Sponsor ^ICMJE	QuatRx Pharmaceuticals Company
Collaborators ^ICMJE
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