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

NCT00729469 | Completed Phase 3 Results

• 1 other identifier: 15-50821
• Study Type: interventional
• Target: 919
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrophy; Vaginal Diseases

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)

  12 weeks

• Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)

  12 weeks

• Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)

  12 weeks

• Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

  12 weeks

• Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)

  12 weeks

• Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)

  12 weeks

• Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)

  12 weeks

• Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

  12 weeks

Secondary Outcomes (8)

• Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)

  4 weeks

• Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)

  4 weeks

• Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)

  4 weeks

• Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

  4 weeks

• Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)

  4 weeks

Study Arms (2)

Ospemifene 60 mg/day and K-Y® lubricant

EXPERIMENTAL

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

Placebo and K-Y® lubricant

PLACEBO COMPARATOR

Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.

Drug: Placebo

Interventions

Ospemifene 60 mg DRUG

60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Also known as: Osphena®

Ospemifene 60 mg/day and K-Y® lubricant

Placebo DRUG

oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Placebo and K-Y® lubricant

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naturally or surgically menopausal
• Moderate or severe symptoms of vaginal atrophy
• % 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

You may not qualify if:

• 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 than signs of vaginal atrophy (e.g.
• uterine or vaginal prolapse of Grade 2 or higher)
• Previous participation in any other ospemifene study

Sponsors & Collaborators

• Shionogi: lead
• Hormos Medical: collaborator
• QuatRx Pharmaceuticals: collaborator

Related Publications (1)

• Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.

  PMID: 23361170 DERIVED

MeSH Terms

Conditions

Atrophy; Vaginal Diseases

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi Inc.

shionogiclintrialsadmin@shionogi.com

800-849-9707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 18, 2018
• Results First Posted: June 28, 2013

Record last verified: 2018-04