Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Shionogi301 enrolled

Overview

The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

301

Conditions

Atrophy Vaginal Diseases

Interventions

Ospemifene 60Mg Oral TabletDRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * Did not have a uterus * Met the inclusion and exclusion criteria for Protocol 15-50310 * Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310 * Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits 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

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Week 13 (Phone Contact) to Week 56 (Visit 4)

Change From Baseline in Serum Lipid Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Serum Lipid Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Blood Pressure at Visit 2

Systolic blood pressure (SBP), diastolic blood pressure (DBP)

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Pulse Rate at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Weight at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Body Mass Index (BMI) at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Blood Pressure at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Pulse Rate at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Weight at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in BMI at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Data from ClinicalTrials.gov

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Change From Baseline in Visual Evaluation of Vagina at Visit 2

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Visual Evaluation of Vagina at Visit 3

Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)

Time frame: Baseline to Week 52 (Visit 3)

Assessment of Cervical Pap Smear Samples (if Cervix is Intact)

Cervical Pap smear samples are 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.

Time frame: Week 52 (Visit 3)

Assessment of Breast Palpation at Visit 2

Breast palpation was used to assess breast abnormalities.

Time frame: Week 26 (Visit 2)

Assessment of Breast Palpation at Visit 3

Breast palpation was used to assess breast abnormalities.

Time frame: Week 52 (Visit 3)

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Erythrocyte Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Hemoglobin Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Erythrocyte Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Hemoglobin Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in MCV and MPV at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Albumin and Total Protein Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Albumin and Total Protein Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in ALT, AST and CK Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in pH of Urine at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Specific Gravity of Urine at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in pH of Urine at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Specific Gravity of Urine at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Estradiol (E2) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in Testosterone Levels at Visit 2

Time frame: Baseline to Week 26 (Visit 2)

Change From Baseline in E2 Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in FSH and LH Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in SHBG Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)

Change From Baseline in Testosterone Levels at Visit 3

Time frame: Baseline to Week 52 (Visit 3)