Clinical trial NCT01586364: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Vaginal Diseases
Keywords: Menopausal symptoms
Vulvar and vaginal atrophy in menopausal women
Vaginal atrophy
Urogenital atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: QuatRx Pharmaceuticals
First posted: 2012-04-26
Enrollment: 301
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Week 13 (Phone Contact) to Week 56 (Visit 4)
measure: Change From Baseline in Serum Lipid Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Serum Lipid Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Blood Pressure at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Pulse Rate at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Weight at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Body Mass Index (BMI) at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Blood Pressure at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Pulse Rate at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Weight at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in BMI at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Visual Evaluation of Vagina at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Visual Evaluation of Vagina at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Assessment of Cervical Pap Smear Samples (if Cervix is Intact)
timeFrame: Week 52 (Visit 3)
measure: Assessment of Breast Palpation at Visit 2
timeFrame: Week 26 (Visit 2)
measure: Assessment of Breast Palpation at Visit 3
timeFrame: Week 52 (Visit 3)
measure: Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Erythrocyte Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Hemoglobin Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Erythrocyte Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Hemoglobin Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in MCV and MPV at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Albumin and Total Protein Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Albumin and Total Protein Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in ALT, AST and CK Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in pH of Urine at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Specific Gravity of Urine at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in pH of Urine at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Specific Gravity of Urine at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Estradiol (E2) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in Testosterone Levels at Visit 2
timeFrame: Baseline to Week 26 (Visit 2)
measure: Change From Baseline in E2 Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in FSH and LH Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in SHBG Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
measure: Change From Baseline in Testosterone Levels at Visit 3
timeFrame: Baseline to Week 52 (Visit 3)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: