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

Phase 3

Completed

• Conditions: Atrophy; Vaginal Diseases
• Interventions: Drug: Ospemifene (Dose 2); Drug: Ospemifene (Dose 1); Drug: Placebo

• Registration Number: NCT01585558
• Lead Sponsor: Shionogi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-16
• Primary Completion: 2008-08-19
• Study Completion: 2008-09-18
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Results First Submitted: 2013-03-20
• Results First Submitted QC: 2013-05-21
• Results First Posted: 2013-06-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 2	Ospemifene (Dose 2)	-
Treatment Group 1	Ospemifene (Dose 1)	-
Treatment Group 3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Evaluation of the Vagina	Baseline to Week 52 (Visit 6)	Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).
Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels	Baseline to Week 26 (Visit 5)
Incidence of Adverse Events (AEs)	Week 20 (Phone Contact) to Week 56 (Visit 7)
Assessment of Cervical Pap Smear Samples	Week 52 (Visit 6)	Cervical Pap smear samples were 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.
Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)	Baseline to Week 26 (Visit 5)	Mean change in endometrial thickness from baseline
Change From Baseline in Follicle Stimulating Hormone (FSH) Levels	Baseline to Week 26 (Visit 5)
Change From Baseline in Testosterone (Free) Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in E2 Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in LH Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in FSH Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Protein S Ag (Free), P Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Thromboplastin Time	Baseline to Week 52 (Visit 6)
Assessment of Breast Palpation	Week 52 (Visit 6)	Breast palpation was done by the investigator to assess abnormalities in the breast.
Change From Baseline in Specific Gravtiy of Urine	Baseline to Week 26 (Visit 5)
Change From Baseline in Antithrombin Antigen, P Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Protein C Ag, P Levels	Baseline to Week 52 (Visit 6)
Mean Percent Change From Baseline in Serum Lipids	Baseline to Week 52 (Visit 6)
Assessment of Endometrial Safety With a TVU	Baseline to Week 52 (Visit 6)	Mean change in endometrial thickness from baseline
Change From Baseline in Estradiol (E2) Levels	Baseline to Week 26 (Visit 5)
Change From Baseline in Luteinizing Hormone (LH) Levels	Baseline to Week 26 (Visit 5)
Change From Baseline in Erythrocyte (RBC) Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Hematocrit Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in pH of Urine	Baseline to Week 52 (Visit 6)
Assessment of Hematology Test Values	Baseline to Week 52 (Visit 6)	Change from baseline
Change From Baseline in Hemoglobin Levels	Baseine to Week 52 (Visit 6)
Assessment of Endometrial Biopsy	Week 52 (Visit 6)	Assessments were based on Blaustein's classification.
Mean Change in Blood Chemistry Parameters	Baseline to Week 52 (Visit 6)
Change From Baseline in Testosterone (Total) Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in SHBG Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Hemogobin Levels	Baseline to Week 26 (Visit 5)
Assessment of Mammography	Week 52 (Visit 6)	Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Assessment of Hematology Tests	Baseline to Week 26 (Visit 5)	Change from baseline
Change From Baseline in Specific Gravity of Urine	Baseline to Week 52 (Visit 6)
Change From Baseline in Weight	Baseline to Week 52 (Visit 6)
Change From Baseline in DBP	Baseline to Week 52 (Visit 6)
Change From Baseline in Fibrinogen Levels	Baseline to Week 52 (Visit 6)
Change From Baseline in Systolic Blood Pressure (SBP)	Baseline to Week 26 (Visit 5)
Change From Baseline in Pulse Rate	Baseline to Week 52 (Visit 6)
Change From Baseline in BMI	Baseline to Week 52 (Visit 6)
Change From Baseline in Diastolic Blood Pressure (DBP)	Baseline to Week 26 (Visit 5)
Change From Baseline in SBP	Baseline to Week 52 (Visit 6)