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A Clinical Study to Evaluate the Safety of Ospemifene

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: QuatRx Pharmaceuticals Company
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

ChemIDplus related topics:   Ospemifene   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
60mg: Experimental
60mg dose
Drug: Ospemifene (orally dosed once daily for 52 weeks)
Ospemifene 60mg orally dosed once daily for 52 weeks
Placebo: Placebo Comparator
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
      Leuven, Belgium
      Gent, Belgium
      Tienen, Belgium
      Ukkel, Belgium
Denmark
      Frederiksberg, Denmark
      Odense, Denmark
      Randers, Denmark
Finland
      Helsinki, Finland
      Turku, Finland
      Tampere, Finland
      Kuopio, Finland
      Joensuu, Finland
      Oulu, Finland
      Kemi, Finland
Sweden
      Stockholm, Sweden
      Kungsbacka, Sweden
      Uppsala, Sweden
      Lund, Sweden

Sponsors and Collaborators
QuatRx Pharmaceuticals Company
Hormos Medical Ltd.
  More 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 / Quatrx Pharmaceuticals Co. ( Hormos Medical Ltd )
Study ID Numbers:   15-50718
First Received:   November 30, 2007
Last Updated:   June 10, 2008
ClinicalTrials.gov Identifier:   NCT00566982
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  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Genital Diseases, Female
Atrophy
Vaginal Diseases
Menopause

ClinicalTrials.gov processed this record on October 10, 2008




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