Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

Shionogi

Status and phase: Completed; Phase 3

Conditions: Vaginal Dryness

Treatments: Drug: Ospemifene; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02638337

1517I0231

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.

Enrollment: 631 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is postmenopausal.
• Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion criteria

• Subject has clinically significant abnormal findings in the physical examination.
• Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2
• Subject has uncontrolled hypertension.
• Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
• Subject has uterine/vaginal bleeding of unknown origin.
• Subject has a vaginal infection requiring medication (may be treated and be eligible for study).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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631 participants in 2 patient groups, including a placebo group

Ospemifene

Experimental group

Description:

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Treatment:

Drug: Ospemifene

Placebo

Placebo Comparator group

Description:

Participants will take one tablet of matching placebo, orally, once a day for 12 weeks.

Treatment:

Drug: Placebo