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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atrophy Vaginal Diseases	Drug: Ospemifene (Dose 1) Drug: Ospemifene (Dose 2) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Ospemifene

U.S. FDA Resources

Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: Week 20 (Phone Contact) to Week 56 (Visit 7) ] [ Designated as safety issue: Yes ]
Assessment of cervical Pap smear samples [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
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.
Assessment of endometrial biopsy [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessments were based on Blaustein's classification. A biopsy was performed at Week 26 (Visit 5) only if the TVU indicted a double-layer thickness of ≥4 mm (as determined by the investigator). If the investigator determined that the endometrium was <4 mm, and the central reader determined that the endometrium was ≥4 mm, an endometrial biopsy was performed after the results from the central reader were received at the site.
Change from baseline in serum lipids [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Change from baseline in serum lipids [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessment of blood chemistry parameters [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Assessment of blood chemistry parameters [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessment of endometrial safety with a transvaginal ultrasound (TVU) [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Assessment of endometrial safety with a TVU [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Change from baseline in visual evaluation of the vagina [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
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).
Change from baseline in visual evaluation of the vagina [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
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).
Change from baseline in serum hormone levels [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Change from baseline in serum hormone levels [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessment of coagulation parameters [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Assessment of breast palpation [ Time Frame: Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Breast palpation was done by the investigator to assess abnormalities in the breast.
Assessment of coagulation parameters [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessment of breast palpation [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Breast palpation was done by the investigator to assess abnormalities in the breast.
Assessment of mammography [ Time Frame: Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Mammography was done for the detection of characteristic masses and microcalcifications in the breast.
Assessment of hematology tests [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Assessment of hematology tests [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Assessment of urinalysis tests [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Urinalysis tests measured the pH and specific gravity of urine.
Assessment of urinalysis tests [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]
Urinalysis tests measured the pH and specific gravity of urine.
Assessment of physical examination and vital signs [ Time Frame: Baseline to Week 26 (Visit 5) ] [ Designated as safety issue: Yes ]
Assessment of physical examination and vital signs [ Time Frame: Baseline to Week 52 (Visit 6) ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	May 2006
Study Completion Date:	September 2008

Arms	Assigned Interventions
Experimental: Treatment Group 1	Drug: Ospemifene (Dose 1)
Experimental: Treatment Group 2	Drug: Ospemifene (Dose 2)
Placebo Comparator: Treatment Group 3	Drug: Placebo

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585558

Sponsors and Collaborators

Shionogi

QuatRx Pharmaceuticals

Investigators

Study Director:

Shionogi Clinical Trials Administrator Clinical Support Help Line

Shionogi

More Information

No publications provided

Responsible Party:	Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov Identifier:	NCT01585558 History of Changes
Other Study ID Numbers:	15-50310X
Study First Received:	April 18, 2012
Last Updated:	April 23, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:

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

Additional relevant MeSH terms:

Vaginal Diseases
Atrophy
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013