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

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 60 mg Drug: Placebo Drug: Non-hormonal vaginal lubricant	Phase 3

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 Shionogi Inc.:

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 ]

Enrollment:	919
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
Experimental: Subjects on ospemifene 60 mg/day and non-hormonal lubricant Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.	Drug: Ospemifene 60 mg 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) Drug: Non-hormonal vaginal lubricant Vaginal lubricant should be used as needed
Placebo Comparator: Subjects on placebo and non-hormonal vaginal lubricant	Drug: Placebo Drug: Non-hormonal vaginal lubricant Vaginal lubricant should be used as needed

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

Sponsors and Collaborators

Shionogi

Hormos Medical

QuatRx Pharmaceuticals

Investigators

Study Director:

Shionogi Clinical Trials Administrator Clinical Support Help Line

Shionogi

More Information

No publications provided

Responsible Party:	Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier:	NCT00729469 History of Changes
Other Study ID Numbers:	15-50821
Study First Received:	August 4, 2008
Last Updated:	April 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:

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

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 May 16, 2013