Phase 3 N=180 Randomized Quadruple-blind Treatment

Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

Atrophy · Vaginal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01585558 ↗

Enrolled (actual)

180

Serious AEs

4.4%

Results posted

Jun 2013

Primary outcome: Primary: Incidence of Adverse Events (AEs) — 38; 44; 22; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ospemifene (Dose 1) (Drug); Ospemifene (Dose 2) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Shionogi
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs)	38; 44; 22; 11; 18; 5	—
PRIMARY Assessment of Cervical Pap Smear Samples	1; 2; 0; 1; 0; 1	—
PRIMARY Assessment of Endometrial Biopsy	44; 53; 32; 1; 1; 0	—
PRIMARY Mean Percent Change From Baseline in Serum Lipids	-0.55; -2.45; -1.05; -0.87; -6.20; -0.42	—
PRIMARY Mean Percent Change From Baseline in Serum Lipids	-0.55; -2.45; -1.05; -0.87; -6.20; -0.42	—
PRIMARY Mean Change in Blood Chemistry Parameters	-2.1; -3.2; -2.2; 1.5; 0.5; 0.3	—
PRIMARY Mean Change in Blood Chemistry Parameters	-2.1; -3.2; -2.2; 1.5; 0.5; 0.3	—
PRIMARY Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)	0.580; 0.818; -0.119	—
PRIMARY Assessment of Endometrial Safety With a TVU	0.681; 1.139; -0.041	—
PRIMARY Change From Baseline in Visual Evaluation of the Vagina	-0.8; -0.7; -0.4; -1.3; -1.2; -0.6	—
PRIMARY Change From Baseline in Visual Evaluation of the Vagina	-0.8; -0.7; -0.4; -1.3; -1.2; -0.6	—
PRIMARY Change From Baseline in Estradiol (E2) Levels	0.75; 0.94; 0.15	—
PRIMARY Change From Baseline in Luteinizing Hormone (LH) Levels	-2.02; -2.86; -0.83	—
PRIMARY Change From Baseline in Follicle Stimulating Hormone (FSH) Levels	-7.44; -9.87; -4.10	—
PRIMARY Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels	11.71; 22.64; -2.74	—
PRIMARY Change From Baseline in Testosterone (Total) Levels	1.92; 3.48; -0.95	—
PRIMARY Change From Baseline in Testosterone (Free) Levels	0.02; -0.01; 0.01	—
PRIMARY Change From Baseline in E2 Levels	0.06; -0.02; 0.14	—
PRIMARY Change From Baseline in LH Levels	-2.65; -4.95; -0.09	—
PRIMARY Change From Baseline in FSH Levels	-12.39; -15.60; -6.29	—
PRIMARY Change From Baseline in SHBG Levels	11.94; 28.09; -5.94	—
PRIMARY Assessment of Mammography	0; 0; 1; 2; 1; 0	—
PRIMARY Change From Baseline in Testosterone (Total) Levels	1.92; 3.48; -0.95	—
PRIMARY Change From Baseline in Testosterone (Free) Levels	0.02; -0.01; 0.01	—
PRIMARY Change From Baseline in Antithrombin Antigen, P Levels	5.1; 1.0; 7.1	—
PRIMARY Change From Baseline in Fibrinogen Levels	-24.0; -36.0; 7.4	—
PRIMARY Change From Baseline in Protein C Ag, P Levels	4.9; -2.9; 10.6	—
PRIMARY Change From Baseline in Protein S Ag (Free), P Levels	7.1; 11.1; 9.3	—
PRIMARY Change From Baseline in Thromboplastin Time	0.4; 0.5; 1.2	—
PRIMARY Change From Baseline in Antithrombin Antigen, P Levels	5.1; 1.0; 7.1	—
PRIMARY Change From Baseline in Fibrinogen Levels	-24.0; -36.0; 7.4	—
PRIMARY Change From Baseline in Protein C Ag, P Levels	4.9; -2.9; 10.6	—
PRIMARY Change From Baseline in Protein S Ag (Free), P Levels	7.1; 11.1; 9.3	—
PRIMARY Change From Baseline in Thromboplastin Time	0.4; 0.5; 1.2	—
PRIMARY Assessment of Breast Palpation	49; 57; 35; 0; 1; 0	—
PRIMARY Assessment of Breast Palpation	49; 57; 35; 0; 1; 0	—
PRIMARY Assessment of Hematology Tests	-0.008; -0.211; 0.207; 0.006; 0.001; -0.005	—
PRIMARY Change From Baseline in Erythrocyte (RBC) Levels	-0.087; -0.155; 0.028	—
PRIMARY Change From Baseline in Hemogobin Levels	-0.150; -0.165; 0.140	—
PRIMARY Change From Baseline in Hematocrit Levels	-0.445; -1.152; 0.174	—
PRIMARY Assessment of Hematology Test Values	0.061; -0.217; 0.371; 0.003; 0.002; -0.003	—
PRIMARY Change From Baseline in Erythrocyte (RBC) Levels	-0.087; -0.155; 0.028	—
PRIMARY Change From Baseline in Hemoglobin Levels	-0.141; -0.431; 0.094	—
PRIMARY Change From Baseline in Hematocrit Levels	-0.445; -1.152; 0.174	—
PRIMARY Change From Baseline in pH of Urine	0.1; 0.0; 0.2	—
PRIMARY Change From Baseline in Specific Gravtiy of Urine	-0.002; -0.003; -0.000	—
PRIMARY Change From Baseline in pH of Urine	0.1; 0.0; 0.2	—
PRIMARY Change From Baseline in Specific Gravity of Urine	-0.001; -0.002; -0.001	—
PRIMARY Change From Baseline in Systolic Blood Pressure (SBP)	-2.1; 2.4; 0.5	—
PRIMARY Change From Baseline in Diastolic Blood Pressure (DBP)	-2.0; 0.5; 0.3	—
PRIMARY Change From Baseline in Pulse Rate	2.6; -0.5; 2.9	—
PRIMARY Change From Baseline in Weight	-0.99; 0.98; 1.99	—
PRIMARY Change From Baseline in BMI	-0.379; 0.376; 0.748	—
PRIMARY Change From Baseline in SBP	-4.5; 0.9; 4.2	—
PRIMARY Change From Baseline in DBP	-2.5; 0.7; 0.8	—
PRIMARY Change From Baseline in Pulse Rate	2.6; -0.5; 2.9	—
PRIMARY Change From Baseline in Weight	-0.99; 0.98; 1.99	—
PRIMARY Change From Baseline in BMI	-0.379; 0.376; 0.748	—

Summary

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact 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
Had an intact uterus
Met the inclusion and exclusion criteria for Protocol 15-50310
Had completed Protocol 15-50310

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 (NCT01585558). 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.