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

NCT02638337 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2019-04-02

Study results available
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Summary

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.

Conditions

  • Vaginal Dryness

Interventions

DRUG

Ospemifene

60 mg tablet

DRUG

Placebo

Tablet identical to the ospemifene tablet without drug

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-26
Primary Completion
2017-06-23
Completion
2017-07-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638337 on ClinicalTrials.gov