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

Sponsor:	QuatRx Pharmaceuticals Company
Information provided by:	QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier:	NCT00729469

Purpose

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.

Condition	Intervention	Phase
Atrophy Vaginal Diseases	Drug: Ospemifene Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Ospemifene

U.S. FDA Resources

Further study details as provided by QuatRx Pharmaceuticals Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	750
Study Start Date:	July 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo comparator	Drug: Placebo
Active Comparator: 2 Ospemifene 60 mg dose	Drug: Ospemifene Ospemifene 60 mg

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729469

Show 114 Study Locations

Sponsors and Collaborators

QuatRx Pharmaceuticals Company

More Information

Publications:

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

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.

Responsible Party:	Quatrx Pharmaceuticals Company
ClinicalTrials.gov Identifier:	NCT00729469 History of Changes
Other Study ID Numbers:	15-50821
Study First Received:	August 4, 2008
Last Updated:	February 2, 2010
Health Authority:	United States: Institutional Review Board

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
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 12, 2012