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

Shionogi

Status and phase

Completed

Phase 3

Conditions

Atrophy

Vaginal Diseases

Treatments

Drug: Ospemifene 60Mg Oral Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01586364

15-50312

Details and patient eligibility

About

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.

Enrollment

301 patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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