A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

This study has been completed.

Sponsor:

Collaborators:

Hormos Medical

QuatRx Pharmaceuticals

Information provided by:

Shionogi Inc.

ClinicalTrials.gov Identifier:

NCT00630539

First received: February 28, 2008

Last updated: April 18, 2012

Last verified: April 2012

History of Changes

Purpose

The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Condition	Intervention	Phase
Atrophy Vaginal Diseases	Drug: Placebo Drug: Ospemifene 5 mg Drug: Ospemifene 15 mg Drug: Ospemifene 30 mg	Phase 2

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 Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Resource links provided by NLM:

Drug Information available for: Ospemifene

U.S. FDA Resources

Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:

Mean change from baseline in percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Mean change in percentage of superficial cells in maturation index of the 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:

Mean change from baseline in visual evaluation of vagina (by gynecological examination) [ Time Frame: Weeks 4 & 12 ] [ Designated as safety issue: Yes ]
Mean change from baseline in vaginal pH [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Mean change from baseline in percentage of superficial cells in the maturation index [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Mean change from baseline in serum hormones [ Time Frame: Weeks 4 & 12 ] [ Designated as safety issue: Yes ]
Mean change from baseline in percentage of parabasal cells in the maturation index [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

Enrollment:	126
Study Start Date:	August 2007
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Subjects on placebo Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks	Drug: Placebo 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 5 mg/day Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 5 mg 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 15 mg/day Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 15 mg 1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Experimental: Subjects on ospemifene 30 mg/day Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 30 mg 1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

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
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: NCT00630539

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:	NCT00630539 History of Changes
Other Study ID Numbers:	15-50717
Study First Received:	February 28, 2008
Last Updated:	April 18, 2012
Health Authority:	Sweden: Institutional Review Board United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Denmark: Danish Dataprotection Agency Finland: Ethics Committee

Keywords provided by Shionogi Inc.:

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

Additional relevant MeSH terms:

Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Atrophy
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 June 18, 2013

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