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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-26

Study Completion Date

2017-07-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginal Dryness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ospemifene

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

Group Type EXPERIMENTAL

Ospemifene

Intervention Type DRUG

60 mg tablet

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet identical to the ospemifene tablet without drug

Interventions

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Ospemifene

60 mg tablet

Intervention Type DRUG

Placebo

Tablet identical to the ospemifene tablet without drug

Intervention Type DRUG

Other Intervention Names

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Osphena®

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No