Completed
PHASE3
INTERVENTIONAL
NCT02638337
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Ospemifene
Type:
DRUG
Description:
60 mg tablet
Name:
Placebo
Type:
DRUG
Description:
Tablet identical to the ospemifene tablet without drug
Primary Outcomes
Measure:
Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12
TimeFrame:
Baseline and Week 12
Description:
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.
Measure:
Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12
TimeFrame:
Baseline and Week 12
Description:
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.
Measure:
Change From Baseline in the Vaginal pH at Week 12
TimeFrame:
Baseline and Week 12
Description:
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.
Measure:
Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12
TimeFrame:
Baseline and Week 12
Description:
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.
Measure:
Number of Participants With Adverse Events
TimeFrame:
From the first dose of study drug up to 14 days after the last dose; 14 weeks
Description:
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.
Trial Information
NCT ID
NCT02638337
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Shionogi
Last Updated
December 15, 2025