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

NCT01585558 | Completed Phase 3 Results

• 1 other identifier: 15-50310X
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrophy; Vaginal Diseases

Keywords

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

Outcome Measures

Primary Outcomes (58)

• Incidence of Adverse Events (AEs)

  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.

  Week 52 (Visit 6)

• Assessment of Endometrial Biopsy

  Assessments were based on Blaustein's classification.

  Week 52 (Visit 6)

• Mean Percent Change From Baseline in Serum Lipids

  Baseline to Week 26 (Visit 5)

• Mean Percent Change From Baseline in Serum Lipids

  Baseline to Week 52 (Visit 6)

• Mean Change in Blood Chemistry Parameters

  Baseline to Week 26 (Visit 5)

• Mean Change in Blood Chemistry Parameters

  Baseline to Week 52 (Visit 6)

• Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)

  Mean change in endometrial thickness from baseline

  Baseline to Week 26 (Visit 5)

• Assessment of Endometrial Safety With a TVU

  Mean change in endometrial thickness from baseline

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Visual Evaluation of the Vagina

  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).

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Visual Evaluation of the Vagina

  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).

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Estradiol (E2) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Luteinizing Hormone (LH) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Follicle Stimulating Hormone (FSH) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Testosterone (Total) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Testosterone (Free) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in E2 Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in LH Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in FSH Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in SHBG Levels

  Baseline to Week 52 (Visit 6)

• Assessment of Mammography

  Mammography was done for the detection of characteristic masses and microcalcifications in the breast.

  Week 52 (Visit 6)

• Change From Baseline in Testosterone (Total) Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Testosterone (Free) Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Antithrombin Antigen, P Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Fibrinogen Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Protein C Ag, P Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Protein S Ag (Free), P Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Thromboplastin Time

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Antithrombin Antigen, P Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Fibrinogen Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Protein C Ag, P Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Protein S Ag (Free), P Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Thromboplastin Time

  Baseline to Week 52 (Visit 6)

• Assessment of Breast Palpation

  Breast palpation was done by the investigator to assess abnormalities in the breast.

  Week 26 (Visit 5)

• Assessment of Breast Palpation

  Breast palpation was done by the investigator to assess abnormalities in the breast.

  Week 52 (Visit 6)

• Assessment of Hematology Tests

  Change from baseline

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Erythrocyte (RBC) Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Hemogobin Levels

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Hematocrit Levels

  Baseline to Week 26 (Visit 5)

• Assessment of Hematology Test Values

  Change from baseline

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Erythrocyte (RBC) Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Hemoglobin Levels

  Baseine to Week 52 (Visit 6)

• Change From Baseline in Hematocrit Levels

  Baseline to Week 52 (Visit 6)

• Change From Baseline in pH of Urine

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Specific Gravtiy of Urine

  Baseline to Week 26 (Visit 5)

• Change From Baseline in pH of Urine

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Specific Gravity of Urine

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Systolic Blood Pressure (SBP)

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Diastolic Blood Pressure (DBP)

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Pulse Rate

  Baseline to Week 26 (Visit 5)

• Change From Baseline in Weight

  Baseline to Week 26 (Visit 5)

• Change From Baseline in BMI

  Baseline to Week 26

• Change From Baseline in SBP

  Baseline to Week 52 (Visit 6)

• Change From Baseline in DBP

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Pulse Rate

  Baseline to Week 52 (Visit 6)

• Change From Baseline in Weight

  Baseline to Week 52 (Visit 6)

• Change From Baseline in BMI

  Baseline to Week 52 (Visit 6)

Study Arms (3)

Treatment Group 1

EXPERIMENTAL

Drug: Ospemifene (Dose 1)

Treatment Group 2

EXPERIMENTAL

Drug: Ospemifene (Dose 2)

Treatment Group 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ospemifene (Dose 1) DRUG

Treatment Group 1

Ospemifene (Dose 2) DRUG

Treatment Group 2

Placebo DRUG

Treatment Group 3

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Had completed Protocol 15-50310
• 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

Sponsors & Collaborators

• Shionogi: lead
• QuatRx Pharmaceuticals: collaborator

Related Publications (1)

• Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

  PMID: 37619252 DERIVED

MeSH Terms

Conditions

Atrophy; Vaginal Diseases

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi Inc.

Shionogiclintrials-admin@shionogi.co.jp

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 26, 2012
• Study Start: May 16, 2006
• Primary Completion: August 19, 2008
• Study Completion: September 18, 2008
• Last Updated: May 21, 2018
• Results First Posted: June 28, 2013

Record last verified: 2018-04