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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atrophy Vaginal Diseases	Drug: Ospemifene	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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: A 52-Week Open-Label 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 13 (Phone Contact) to Week 56 (Visit 4) ] [ Designated as safety issue: Yes ]
Assessment of clinical safety laboratory parameters, coagulation parameters, urinalysis, serum lipid levels, and hormone levels at Visit 2 [ Time Frame: Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
Clinical safety laboratory parameters include: red blood cell (RBC) count, white blood cell (WBC) count, differential, platelet count, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), RBC distribution width (RDW), mean platelet volume (MPV), albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, total protein, glucose, uric acid, blood urea nitrogen (BUN), and creatine kinase (CK).
Assessment of clinical safety laboratory parameters, coagulation parameters, urinalysis, serum lipid levels, and hormone levels at Visit 3 [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
Clinical safety laboratory parameters include: red blood cell (RBC) count, white blood cell (WBC) count, differential, platelet count, hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), RBC distribution width (RDW), mean platelet volume (MPV), albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, total protein, glucose, uric acid, blood urea nitrogen (BUN), and creatine kinase (CK).
Assessment of physical examination and vital signs at Visit 2 [ Time Frame: Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
Assessment of physical examination and vital signs at Visit 3 [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
Assessment of physical examination and vital signs at Visit 4 [ Time Frame: Week 56 (Visit 4) ] [ Designated as safety issue: Yes ]
Assessment of gynecological examination at Visit 2 [ Time Frame: Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
Visual evaluation of the vagina (petechiae, pallor, friability, vaginal dryness, and redness seen in vaginal mucosa), assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe), was performed as part of the gynecological examination
Assessment of gynecological examination at Visit 3 [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
Visual evaluation of the vagina (petechiae, pallor, friability, vaginal dryness, and redness seen in vaginal mucosa), assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe), was performed as part of the gynecological examination
Assessment of gynecological examination at Visit 4 [ Time Frame: Week 56 (Visit 4) ] [ Designated as safety issue: Yes ]
Visual evaluation of the vagina (petechiae, pallor, friability, vaginal dryness, and redness seen in vaginal mucosa), assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe), was performed as part of the gynecological examination
Assessment of cervical Pap smear samples (if cervix is intact) [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
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.
Assessment of breast palpation at Visit 2 [ Time Frame: Week 26 (Visit 2) ] [ Designated as safety issue: Yes ]
Breast palpation is used to assess breast abnormalities.
Assessment of breast palpation at Visit 3 [ Time Frame: Week 52 (Visit 3) ] [ Designated as safety issue: Yes ]
Breast palpation is used to assess breast abnormalities.

Enrollment:	301
Study Start Date:	May 2006

Arms	Assigned Interventions
Experimental: Treatment Arm	Drug: Ospemifene

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586364

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:	NCT01586364 History of Changes
Other Study ID Numbers:	15-50312
Study First Received:	April 18, 2012
Last Updated:	April 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:

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

Additional relevant MeSH terms:

Vaginal Diseases
Atrophy
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013