A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Shionogi

Status and phase: Completed; Phase 3

Conditions: Atrophy; Vaginal Diseases

Treatments: Drug: Ospemifene 30 mg; Drug: Ospemifene 60 mg; Drug: Placebo; Drug: Nonhormonal vaginal lubricant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276094

15-50310

Details and patient eligibility

About

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Enrollment: 826 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naturally or surgically postmenopausal
• Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)
• Vaginal pH greater than 5.0
• 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion criteria

• Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology
• Abnormal Pap smear
• Uterine bleeding of unknown origin or uterine polyps
• Current vaginal infection requiring medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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826 participants in 3 patient groups, including a placebo group

Ospemifene 30 mg/day and nonhormonal vaginal lubricant

Experimental group

Description:

Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

Treatment:

Drug: Nonhormonal vaginal lubricant

Drug: Ospemifene 30 mg

Ospemifene 60 mg/day and nonhormonal vaginal lubricant

Experimental group

Description:

Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

Treatment:

Drug: Nonhormonal vaginal lubricant

Drug: Ospemifene 60 mg

Placebo tablets and nonhormonal vaginal lubricant

Placebo Comparator group

Description:

Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.

Treatment:

Drug: Nonhormonal vaginal lubricant

Drug: Placebo