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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586364
• Other study ID #: 15-50312
• Status: Completed
• Phase: Phase 3
• Start date: May 8, 2006
• Est. completion date: December 22, 2008

Study information

• Verified date: April 2018
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

Drug:
• Ospemifene 60Mg Oral Tablet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shionogi	QuatRx Pharmaceuticals

Outcome

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)