Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

April 19, 2018 updated by: Shionogi

Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
  • Had an intact uterus
  • Met the inclusion and exclusion criteria for Protocol 15-50310
  • Had completed Protocol 15-50310

Exclusion Criteria:

  • Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
  • Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group 1
Drug: Ospemifene (Dose 1)
Experimental: Treatment Group 2
Drug: Ospemifene (Dose 2)
Placebo Comparator: Treatment Group 3
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Week 20 (Phone Contact) to Week 56 (Visit 7)
Week 20 (Phone Contact) to Week 56 (Visit 7)
Assessment of Cervical Pap Smear Samples
Time Frame: Week 52 (Visit 6)
Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.
Week 52 (Visit 6)
Assessment of Endometrial Biopsy
Time Frame: Week 52 (Visit 6)
Assessments were based on Blaustein's classification.
Week 52 (Visit 6)
Mean Percent Change From Baseline in Serum Lipids
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Mean Percent Change From Baseline in Serum Lipids
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Mean Change in Blood Chemistry Parameters
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Mean Change in Blood Chemistry Parameters
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)
Time Frame: Baseline to Week 26 (Visit 5)
Mean change in endometrial thickness from baseline
Baseline to Week 26 (Visit 5)
Assessment of Endometrial Safety With a TVU
Time Frame: Baseline to Week 52 (Visit 6)
Mean change in endometrial thickness from baseline
Baseline to Week 52 (Visit 6)
Change From Baseline in Visual Evaluation of the Vagina
Time Frame: Baseline to Week 26 (Visit 5)
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Baseline to Week 26 (Visit 5)
Change From Baseline in Visual Evaluation of the Vagina
Time Frame: Baseline to Week 52 (Visit 6)
Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Baseline to Week 52 (Visit 6)
Change From Baseline in Estradiol (E2) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Luteinizing Hormone (LH) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Total) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Free) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in E2 Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in LH Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in FSH Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in SHBG Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Assessment of Mammography
Time Frame: Week 52 (Visit 6)
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Week 52 (Visit 6)
Change From Baseline in Testosterone (Total) Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Testosterone (Free) Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Antithrombin Antigen, P Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Fibrinogen Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Protein C Ag, P Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Protein S Ag (Free), P Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Thromboplastin Time
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Antithrombin Antigen, P Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Fibrinogen Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Protein C Ag, P Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Protein S Ag (Free), P Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Thromboplastin Time
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Assessment of Breast Palpation
Time Frame: Week 26 (Visit 5)
Breast palpation was done by the investigator to assess abnormalities in the breast.
Week 26 (Visit 5)
Assessment of Breast Palpation
Time Frame: Week 52 (Visit 6)
Breast palpation was done by the investigator to assess abnormalities in the breast.
Week 52 (Visit 6)
Assessment of Hematology Tests
Time Frame: Baseline to Week 26 (Visit 5)
Change from baseline
Baseline to Week 26 (Visit 5)
Change From Baseline in Erythrocyte (RBC) Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Hemogobin Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Hematocrit Levels
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Assessment of Hematology Test Values
Time Frame: Baseline to Week 52 (Visit 6)
Change from baseline
Baseline to Week 52 (Visit 6)
Change From Baseline in Erythrocyte (RBC) Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Hemoglobin Levels
Time Frame: Baseine to Week 52 (Visit 6)
Baseine to Week 52 (Visit 6)
Change From Baseline in Hematocrit Levels
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in pH of Urine
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Specific Gravtiy of Urine
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in pH of Urine
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Specific Gravity of Urine
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Pulse Rate
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in Weight
Time Frame: Baseline to Week 26 (Visit 5)
Baseline to Week 26 (Visit 5)
Change From Baseline in BMI
Time Frame: Baseline to Week 26
Baseline to Week 26
Change From Baseline in SBP
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in DBP
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Pulse Rate
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in Weight
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)
Change From Baseline in BMI
Time Frame: Baseline to Week 52 (Visit 6)
Baseline to Week 52 (Visit 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shionogi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
QuatRx Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-50310X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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