Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

NCT02638337 | Completed Phase 3 Results

• 1 other identifier: 1517I0231
• Study Type: interventional
• Target: 631
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.

Conditions

Vaginal Dryness

Keywords

Vulvo-vaginal Atrophy; menopause

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12

  Parabasal cells are immature squamous cells in the lining of the vagina. A predominance of parabasal cells indicates absence of estrogenic stimulation and vaginal atrophy. Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist. A decrease in parabasal cells indicates improvement in vaginal atrophy. To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used.

  Baseline and Week 12

• Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12

  Superficial cells are mature squamous cells in the lining of the vagina that can decrease in number after menopause resulting in vulvovaginal atrophy. Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist. An increase in the number of superficial cells indicates improvement in atrophy. To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used.

  Baseline and Week 12

• Change From Baseline in the Vaginal pH at Week 12

  The pH scale ranges from 0 to 14. A pH of 7 is neutral, less than 7 is acidic, and greater than 7 is basic. A typical vaginal pH in women of reproductive age is between 3.5 and 4.5, increasing to \> 4.5 after menopause. Vaginal pH was measured by the investigator using a pH indicator strip at the middle third of the vaginal wall. To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used.

  Baseline and Week 12

• Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12

  The severity of the most bothersome symptom of vaginal dryness was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.

  Baseline and Week 12

• Number of Participants With Adverse Events

  Treatment-related adverse events (AEs) were defined as AEs that were considered by the investigator to be related to investigational medicinal product, for which causal relationship with the study drug could be reasonably explained. A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening condition * Hospitalization or prolongation of existing hospitalization for treatment * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important conditions that, based on medical judgment, may jeopardize the participant's health and may require medical intervention to prevent one of the outcomes listed above.

  From the first dose of study drug up to 14 days after the last dose; 14 weeks

Secondary Outcomes (34)

• Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8

  Baseline and Weeks 4 and 8

• Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8

  Baseline and Weeks 4 and 8

• Change From Baseline in the Vaginal pH

  Baseline and Weeks 4 and 8

• Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Weeks 4 and 8

  Baseline and Weeks 4 and 8

• Change From Baseline in Vaginal and/or Vulvar Irritation or Itching

  Baseline and Weeks 4, 8, and 12

Study Arms (2)

Ospemifene

EXPERIMENTAL

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Drug: Ospemifene

Placebo

PLACEBO COMPARATOR

Participants will take one tablet of matching placebo, orally, once a day for 12 weeks.

Drug: Placebo

Interventions

Ospemifene DRUG

60 mg tablet

Also known as: Osphena®

Ospemifene

Placebo DRUG

Tablet identical to the ospemifene tablet without drug

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is postmenopausal.
• Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

You may not qualify if:

• Subject has clinically significant abnormal findings in the physical examination.
• Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2
• Subject has uncontrolled hypertension.
• Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
• Subject has uterine/vaginal bleeding of unknown origin.
• Subject has a vaginal infection requiring medication (may be treated and be eligible for study).

Sponsors & Collaborators

• Shionogi: lead

Related Publications (2)

• 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

• Archer DF, Goldstein SR, Simon JA, Waldbaum AS, Sussman SA, Altomare C, Zhu J, Yoshida Y, Schaffer S, Soulban G. Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Menopause. 2019 Jan 28;26(6):611-621. doi: 10.1097/GME.0000000000001292.

  PMID: 30694917 DERIVED

MeSH Terms

Interventions

Ospemifene

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 23, 2015
• Study Start: January 26, 2016
• Primary Completion: June 23, 2017
• Study Completion: July 5, 2017
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03