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

Shionogi180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Atrophy Vaginal Diseases

Interventions

Ospemifene (Dose 1)DRUG

Ospemifene (Dose 2)DRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Week 20 (Phone Contact) to Week 56 (Visit 7)

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.

Time frame: Week 52 (Visit 6)

Assessment of Endometrial Biopsy

Assessments were based on Blaustein's classification.

Time frame: Week 52 (Visit 6)

Mean Percent Change From Baseline in Serum Lipids

Time frame: Baseline to Week 26 (Visit 5)

Mean Percent Change From Baseline in Serum Lipids

Time frame: Baseline to Week 52 (Visit 6)

Mean Change in Blood Chemistry Parameters

Time frame: Baseline to Week 26 (Visit 5)

Mean Change in Blood Chemistry Parameters

Time frame: Baseline to Week 52 (Visit 6)

Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)

Mean change in endometrial thickness from baseline

Time frame: Baseline to Week 26 (Visit 5)

Assessment of Endometrial Safety With a TVU

Mean change in endometrial thickness from baseline

Time frame: Baseline to Week 52 (Visit 6)

Change From Baseline in Visual Evaluation of the Vagina

Data from ClinicalTrials.gov

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