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

NCT01586364 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 15-50312
• Study Type: interventional
• Target: 301
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrophy; Vaginal Diseases

Keywords

Menopausal symptoms; Vulvar and vaginal atrophy in menopausal women; Vaginal atrophy; Urogenital atrophy

Outcome Measures

Primary Outcomes (50)

• Incidence of Adverse Events (AEs)

  Week 13 (Phone Contact) to Week 56 (Visit 4)

• Change From Baseline in Serum Lipid Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Serum Lipid Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Blood Pressure at Visit 2

  Systolic blood pressure (SBP), diastolic blood pressure (DBP)

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Pulse Rate at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Weight at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Body Mass Index (BMI) at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Blood Pressure at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Pulse Rate at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Weight at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in BMI at Visit 3

  Baseline to Week 52 (Visit 3)

• 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)

• 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)

• 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)

• Assessment of Breast Palpation at Visit 2

  Breast palpation was used to assess breast abnormalities.

  Week 26 (Visit 2)

• Assessment of Breast Palpation at Visit 3

  Breast palpation was used to assess breast abnormalities.

  Week 52 (Visit 3)

• Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Erythrocyte Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Hemoglobin Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Erythrocyte Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Hemoglobin Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in MCV and MPV at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Albumin and Total Protein Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Albumin and Total Protein Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in ALT, AST and CK Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in pH of Urine at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Specific Gravity of Urine at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in pH of Urine at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Specific Gravity of Urine at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Estradiol (E2) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in Testosterone Levels at Visit 2

  Baseline to Week 26 (Visit 2)

• Change From Baseline in E2 Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in FSH and LH Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in SHBG Levels at Visit 3

  Baseline to Week 52 (Visit 3)

• Change From Baseline in Testosterone Levels at Visit 3

  Baseline to Week 52 (Visit 3)

Study Arms (1)

Ospemifene 60 mg Oral Tablet

EXPERIMENTAL

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Drug: Ospemifene 60Mg Oral Tablet

Interventions

Ospemifene 60Mg Oral Tablet DRUG

Also known as: Osphena®

Ospemifene 60 mg Oral Tablet

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shionogi: lead
• QuatRx Pharmaceuticals: collaborator

MeSH Terms

Conditions

Atrophy; Vaginal Diseases

Interventions

Ospemifene; Tablets

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi Inc.

shionogiclintrialsadmin@shionogi.com

800-849-9707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 26, 2012
• Study Start: May 8, 2006
• Primary Completion: November 21, 2008
• Study Completion: December 22, 2008
• Last Updated: May 21, 2018
• Results First Posted: June 28, 2013

Record last verified: 2018-04