Trial · NCT00729469
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
NCT00729469, Phase 3, Completed, Shionogi; results first posted 2013-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity. Trials, record NCT00729469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
- NCT number
- NCT00729469
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 919 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Atrophy, Vaginal Diseases
- Interventions
- Ospemifene 60 mg, Placebo
- First posted
- 2008-08-07
- Last updated
- 2018-05-18
- Results first posted
- 2013-06-28
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | 12 weeks | |
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 12 weeks | |
| Secondary | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | 4 weeks | |
| Secondary | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 4 weeks |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | 12 weeks | ITT; LOCF | percentage of parabasal cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | 12 weeks | ITT; LOCF | percentage of superficial cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | 12 weeks | ITT; LOCF | pH | MEAN |
| SECONDARY | Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | 4 weeks | ITT | percentage of parabasal cells | MEAN |
| SECONDARY | Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | 4 weeks | ITT | percentage of superficial cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) | 12 weeks | ITT; LOCF | participants | NUMBER |
| PRIMARY | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) | 12 weeks | ITT; LOCF | percentage of parabasal cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) | 12 weeks | ITT; LOCF | percentage of superficial cells | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) | 12 weeks | ITT; LOCF | pH | MEAN |
| PRIMARY | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) | 12 weeks | ITT; LOCF | participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | Subjects on Placebo | -3.7 | Standard Deviation 29.97 | percentage of parabasal cells | |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) | Subjects on Ospemifene 60 mg/Day | -31.7 | Standard Deviation 37.25 | percentage of parabasal cells | |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | Subjects on Placebo | 3.3 | Standard Deviation 9.02 | percentage of superficial cells | |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) | Subjects on Ospemifene 60 mg/Day | 12.4 | Standard Deviation 15.36 | percentage of superficial cells | |
| Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | Subjects on Placebo | -0.24 | Standard Deviation 0.800 | pH | |
| Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) | Subjects on Ospemifene 60 mg/Day | -0.92 | Standard Deviation 1.100 | pH | |
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | Subjects on Placebo | -2.8 | Standard Deviation 2.18 | percentage of parabasal cells | |
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) | Subjects on Ospemifene 60 mg/Day | -31.2 | Standard Deviation 2.15 | percentage of parabasal cells | |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | Subjects on Placebo | 3.6 | Standard Deviation 1.07 | percentage of superficial cells | |
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) | Subjects on Ospemifene 60 mg/Day | 12.7 | Standard Deviation 1.05 | percentage of superficial cells |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Subjects on Placebo | 456 | |
| Overall Study | STARTED | Subjects on Ospemifene 60 mg/Day | 463 | |
| Overall Study | COMPLETED | Subjects on Placebo | 403 | |
| Overall Study | COMPLETED | Subjects on Ospemifene 60 mg/Day | 416 | |
| Overall Study | NOT COMPLETED | Subjects on Placebo | 53 | |
| Overall Study | NOT COMPLETED | Subjects on Ospemifene 60 mg/Day | 47 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | Infections and infestations | Subjects on Placebo | 23 | 456 | |
| other | Urinary Tract Infection | Infections and infestations | Subjects on Ospemifene 60 mg/Day | 37 | 463 | |
| other | Nasopharyngitis | Infections and infestations | Subjects on Placebo | 16 | 456 | |
| other | Nasopharyngitis | Infections and infestations | Subjects on Ospemifene 60 mg/Day | 20 | 463 | |
| other | Vulvovaginal Candidiasis | Infections and infestations | Subjects on Placebo | 2 | 456 | |
| other | Vulvovaginal Candidiasis | Infections and infestations | Subjects on Ospemifene 60 mg/Day | 18 | 463 | |
| other | Vulvovaginal Mycotic Infection | Infections and infestations | Subjects on Placebo | 2 | 456 | |
| other | Vulvovaginal Mycotic Infection | Infections and infestations | Subjects on Ospemifene 60 mg/Day | 17 | 463 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Subjects on Placebo | 21 | 456 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Subjects on Ospemifene 60 mg/Day | 15 | 463 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subjects on Placebo | ||
| Total, all-cause mortality | Subjects on Ospemifene 60 mg/Day | ||
| Total, other adverse events | Subjects on Placebo | 102 | 456 |
| Total, other adverse events | Subjects on Ospemifene 60 mg/Day | 153 | 463 |
| Total, serious adverse events | Subjects on Placebo | 7 | 456 |
| Total, serious adverse events | Subjects on Ospemifene 60 mg/Day | 6 | 463 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23361170 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Subjects on Ospemifene 60 mg/Day vs Subjects on Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00729469
GET https://conductscience.org/api/trials/v1/NCT00729469/results?page=2