A Clinical Study to Evaluate the Safety of Ospemifene - Full Text View

Sponsor:	QuatRx Pharmaceuticals Company
Collaborator:	Hormos Medical Ltd.
Information provided by:	QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier:	NCT00566982

Purpose

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.

Condition	Intervention	Phase
Atrophy Vaginal Diseases	Drug: Ospemifene (orally dosed once daily for 52 weeks) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Ospemifene

U.S. FDA Resources

Further study details as provided by QuatRx Pharmaceuticals Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	350
Study Start Date:	October 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 60mg 60mg dose	Drug: Ospemifene (orally dosed once daily for 52 weeks) Ospemifene 60mg orally dosed once daily for 52 weeks
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566982

Locations

Belgium

Gent, Belgium

Leuven, Belgium

Tienen, Belgium

Ukkel, Belgium
Denmark

Frederiksberg, Denmark

Odense, Denmark

Randers, Denmark
Finland

Helsinki, Finland

Joensuu, Finland

Kemi, Finland

Kuopio, Finland

Oulu, Finland

Tampere, Finland

Turku, Finland
Sweden

Kungsbacka, Sweden

Lund, Sweden

Stockholm, Sweden

Uppsala, Sweden

Sponsors and Collaborators

QuatRx Pharmaceuticals Company

Hormos Medical Ltd.

More Information

Additional Information:

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

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.

Nachtigall L et al. Update on Vaginal Atrophy. Menopause Management September/October:17-9, 2005

Responsible Party:	Hormos Medical Ltd, Hormos Medical Ltd / Quatrx Pharmaceuticals Co.
ClinicalTrials.gov Identifier:	NCT00566982 History of Changes
Other Study ID Numbers:	15-50718
Study First Received:	November 30, 2007
Last Updated:	July 10, 2009
Health Authority:	United States: Food and Drug Administration; Finland: Ethics Committee; Sweden: Institutional Review Board; Denmark: Danish Dataprotection Agency; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by QuatRx Pharmaceuticals Company:

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

Additional relevant MeSH terms:

Vaginal Diseases
Atrophy
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 12, 2012