A Clinical Study to Evaluate the Safety of Ospemifene

Shionogi

Status and phase: Completed; Phase 3

Conditions: Atrophy; Vaginal Diseases

Treatments: Drug: Ospemifene 60 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566982

15-50718

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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426 participants in 2 patient groups, including a placebo group

Ospemifene 60 mg/day

Experimental group

Description:

Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.

Treatment:

Drug: Ospemifene 60 mg

Placebo

Placebo Comparator group

Description:

Placebo will be taken once daily, in the morning, with food for 52 weeks.

Treatment:

Drug: Placebo