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 Clinical Trial

Official title:

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: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585558
• Other study ID #: 15-50310X
• Status: Completed
• Phase: Phase 3
• Start date: May 16, 2006
• Est. completion date: September 18, 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 18, 2008
• Est. primary completion date: August 19, 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

• 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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

Drug:
• Ospemifene (Dose 1)

• Ospemifene (Dose 2)

• Placebo

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 20 (Phone Contact) to Week 56 (Visit 7)
Primary	Assessment of Cervical Pap Smear Samples	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.	Week 52 (Visit 6)
Primary	Assessment of Endometrial Biopsy	Assessments were based on Blaustein's classification.	Week 52 (Visit 6)
Primary	Mean Percent Change From Baseline in Serum Lipids		Baseline to Week 26 (Visit 5)
Primary	Mean Percent Change From Baseline in Serum Lipids		Baseline to Week 52 (Visit 6)
Primary	Mean Change in Blood Chemistry Parameters		Baseline to Week 26 (Visit 5)
Primary	Mean Change in Blood Chemistry Parameters		Baseline to Week 52 (Visit 6)
Primary	Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)	Mean change in endometrial thickness from baseline	Baseline to Week 26 (Visit 5)
Primary	Assessment of Endometrial Safety With a TVU	Mean change in endometrial thickness from baseline	Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Visual Evaluation of the Vagina	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).	Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Visual Evaluation of the Vagina	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).	Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Estradiol (E2) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Luteinizing Hormone (LH) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Follicle Stimulating Hormone (FSH) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Testosterone (Total) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Testosterone (Free) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in E2 Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in LH Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in FSH Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in SHBG Levels		Baseline to Week 52 (Visit 6)
Primary	Assessment of Mammography	Mammography was done for the detection of characteristic masses and microcalcifications in the breast.	Week 52 (Visit 6)
Primary	Change From Baseline in Testosterone (Total) Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Testosterone (Free) Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Antithrombin Antigen, P Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Fibrinogen Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Protein C Ag, P Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Protein S Ag (Free), P Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Thromboplastin Time		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Antithrombin Antigen, P Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Fibrinogen Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Protein C Ag, P Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Protein S Ag (Free), P Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Thromboplastin Time		Baseline to Week 52 (Visit 6)
Primary	Assessment of Breast Palpation	Breast palpation was done by the investigator to assess abnormalities in the breast.	Week 26 (Visit 5)
Primary	Assessment of Breast Palpation	Breast palpation was done by the investigator to assess abnormalities in the breast.	Week 52 (Visit 6)
Primary	Assessment of Hematology Tests	Change from baseline	Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Erythrocyte (RBC) Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Hemogobin Levels		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Hematocrit Levels		Baseline to Week 26 (Visit 5)
Primary	Assessment of Hematology Test Values	Change from baseline	Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Erythrocyte (RBC) Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Hemoglobin Levels		Baseine to Week 52 (Visit 6)
Primary	Change From Baseline in Hematocrit Levels		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in pH of Urine		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Specific Gravtiy of Urine		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in pH of Urine		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Specific Gravity of Urine		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Systolic Blood Pressure (SBP)		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Diastolic Blood Pressure (DBP)		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Pulse Rate		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in Weight		Baseline to Week 26 (Visit 5)
Primary	Change From Baseline in BMI		Baseline to Week 26
Primary	Change From Baseline in SBP		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in DBP		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Pulse Rate		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in Weight		Baseline to Week 52 (Visit 6)
Primary	Change From Baseline in BMI		Baseline to Week 52 (Visit 6)