Atrophy Clinical Trial
Official title:
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: A 52-Week Open-Label Follow-Up to Protocol 15-50310
Verified date | April 2018 |
Source | Shionogi Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 301 |
Est. completion date | December 22, 2008 |
Est. primary completion date | November 21, 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shionogi | QuatRx Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events (AEs) | Week 13 (Phone Contact) to Week 56 (Visit 4) | ||
Primary | Change From Baseline in Serum Lipid Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Serum Lipid Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Blood Pressure at Visit 2 | Systolic blood pressure (SBP), diastolic blood pressure (DBP) | Baseline to Week 26 (Visit 2) | |
Primary | Change From Baseline in Pulse Rate at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Weight at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Body Mass Index (BMI) at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Blood Pressure at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Pulse Rate at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Weight at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in BMI at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | 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) | Baseline to Week 26 (Visit 2) | |
Primary | 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) | Baseline to Week 52 (Visit 3) | |
Primary | 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. | Week 52 (Visit 3) | |
Primary | Assessment of Breast Palpation at Visit 2 | Breast palpation was used to assess breast abnormalities. | Week 26 (Visit 2) | |
Primary | Assessment of Breast Palpation at Visit 3 | Breast palpation was used to assess breast abnormalities. | Week 52 (Visit 3) | |
Primary | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Erythrocyte Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Hemoglobin Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Erythrocyte Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Hemoglobin Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in MCV and MPV at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Albumin and Total Protein Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Albumin and Total Protein Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in ALT, AST and CK Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in pH of Urine at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Specific Gravity of Urine at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in pH of Urine at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Specific Gravity of Urine at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Estradiol (E2) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in Testosterone Levels at Visit 2 | Baseline to Week 26 (Visit 2) | ||
Primary | Change From Baseline in E2 Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in FSH and LH Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in SHBG Levels at Visit 3 | Baseline to Week 52 (Visit 3) | ||
Primary | Change From Baseline in Testosterone Levels at Visit 3 | Baseline to Week 52 (Visit 3) |
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