Phase 3 N=301 Treatment

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 · Vaginal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01586364 ↗

Enrolled (actual)

301

Serious AEs

4.3%

Results posted

Jun 2013

Primary outcome: Primary: Incidence of Adverse Events (AEs) — 220; 67; 34; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ospemifene 60Mg Oral Tablet (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Shionogi
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs)	220; 67; 34; 13; 38	—
PRIMARY Change From Baseline in Serum Lipid Levels at Visit 2	1.59; 2.83; 2.81; 11.51	—
PRIMARY Change From Baseline in Serum Lipid Levels at Visit 3	-0.02; -0.54; 2.74; 13.07	—
PRIMARY Change From Baseline in Blood Pressure at Visit 2	-1.2; -0.7	—
PRIMARY Change From Baseline in Pulse Rate at Visit 2	2.1	—
PRIMARY Change From Baseline in Weight at Visit 2	0.798	—
PRIMARY Change From Baseline in Body Mass Index (BMI) at Visit 2	0.309	—
PRIMARY Change From Baseline in Blood Pressure at Visit 3	-1.2; -1.0	—
PRIMARY Change From Baseline in Pulse Rate at Visit 3	3.3	—
PRIMARY Change From Baseline in Weight at Visit 3	1.122	—
PRIMARY Change From Baseline in BMI at Visit 3	0.439	—
PRIMARY Change From Baseline in Visual Evaluation of Vagina at Visit 2	-0.6; -1.0; -0.8; -1.4; -0.6	—
PRIMARY Change From Baseline in Visual Evaluation of Vagina at Visit 3	-0.6; -1.2; -0.8; -1.5; -0.8	—
PRIMARY Assessment of Cervical Pap Smear Samples (if Cervix is Intact)	1; 15	—
PRIMARY Assessment of Breast Palpation at Visit 2	243; 0	—
PRIMARY Assessment of Breast Palpation at Visit 3	198; 1	—
PRIMARY Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2	0.4; -1.3; 9.6	—
PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2	-1.5	—
PRIMARY Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2	-25.4	—
PRIMARY Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3	2.4; 4.3; 12.9	—
PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3	-0.7	—
PRIMARY Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3	-29.9	—
PRIMARY Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2	-0.17; -0.058; -0.012; -6.2	—
PRIMARY Change From Baseline in Erythrocyte Levels at Visit 2	-0.098	—
PRIMARY Change From Baseline in Hemoglobin Levels at Visit 2	-0.29	—
PRIMARY Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2	-0.86; 0.07	—
PRIMARY Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2	0.02; 0.01	—
PRIMARY Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3	-0.05; -0.010; -0.021; -13.5	—
PRIMARY Change From Baseline in Erythrocyte Levels at Visit 3	-0.108	—
PRIMARY Change From Baseline in Hemoglobin Levels at Visit 3	-0.35	—
PRIMARY Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3	-0.97; 0.14	—
PRIMARY Change From Baseline in MCV and MPV at Visit 3	0.01; -0.03	—
PRIMARY Change From Baseline in Albumin and Total Protein Levels at Visit 2	-0.10; -0.14	—
PRIMARY Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2	-3.7; -0.1; -6.7	—
PRIMARY Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2	-0.08; -0.06; 3.2; -0.02; 0.5	—
PRIMARY Change From Baseline in Albumin and Total Protein Levels at Visit 3	-0.08; -0.19	—
PRIMARY Change From Baseline in ALT, AST and CK Levels at Visit 3	-4.1; 0.2; 2.6	—
PRIMARY Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3	-0.08; -0.04; 3.6; 0.03; 0.7	—
PRIMARY Change From Baseline in pH of Urine at Visit 2	-0.11	—
PRIMARY Change From Baseline in Specific Gravity of Urine at Visit 2	0.0003	—
PRIMARY Change From Baseline in pH of Urine at Visit 3	-0.09	—
PRIMARY Change From Baseline in Specific Gravity of Urine at Visit 3	-0.0010	—
PRIMARY Change From Baseline in Estradiol (E2) Levels at Visit 2	0.5	—
PRIMARY Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2	-10.3; -2.2	—
PRIMARY Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2	19.5	—
PRIMARY Change From Baseline in Testosterone Levels at Visit 2	-0.03; 1.45	—
PRIMARY Change From Baseline in E2 Levels at Visit 3	0.4	—
PRIMARY Change From Baseline in FSH and LH Levels at Visit 3	-15.9; -1.7	—
PRIMARY Change From Baseline in SHBG Levels at Visit 3	20.1	—
PRIMARY Change From Baseline in Testosterone Levels at Visit 3	0.00; 2.23	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01586364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.