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

Shionogi

Status and phase: Completed; Phase 3

Conditions: Atrophy; Vaginal Diseases

Treatments: Drug: Ospemifene (Dose 2); Drug: Placebo; Drug: Ospemifene (Dose 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585558

15-50310X

Details and patient eligibility

About

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.

Enrollment: 180 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

180 participants in 3 patient groups, including a placebo group

Treatment Group 1

Experimental group

Treatment:

Drug: Ospemifene (Dose 1)

Treatment Group 2

Experimental group

Treatment:

Drug: Ospemifene (Dose 2)

Treatment Group 3

Placebo Comparator group

Treatment:

Drug: Placebo