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COMPLETEDPhase 3NCT02638337

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

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 ...

Lead sponsor: Shionogi•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Shionogi

Age

40 - 80 years

Sex

FEMALE

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 2, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment631

Start dateJan 2016

Last updatedApr 2, 2019

Condition

Vaginal Dryness

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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