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

Shionogi

Status and phase: Completed; Phase 2

Conditions: Atrophy; Vaginal Diseases

Treatments: Drug: Ospemifene 15 mg; Drug: Ospemifene 5 mg; Drug: Ospemifene 30 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630539

15-50717

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 4 patient groups, including a placebo group

Subjects on placebo

Placebo Comparator group

Description:

Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks

Treatment:

Drug: Placebo

Subjects on ospemifene 5 mg/day

Experimental group

Description:

Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks

Treatment:

Drug: Ospemifene 5 mg

Subjects on ospemifene 15 mg/day

Experimental group

Description:

Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks

Treatment:

Drug: Ospemifene 15 mg

Subjects on ospemifene 30 mg/day

Experimental group

Description:

Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Treatment:

Drug: Ospemifene 30 mg