Trial · NCT00816556
A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
NCT00816556, Phase 3, Terminated, Maire Mac Bride; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis. Trials, record NCT00816556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00816556
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
- NCT number
- NCT00816556
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- Maire Mac Bride
- Conditions
- Atrophic Vaginitis
- Interventions
- Estriol, Estradiol valerate, Vanicream Lite
- First posted
- 2009-01-01
- Last updated
- 2017-11-13
- Results first posted
- 2014-03-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | baseline, 12 weeks | The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome. |
| Secondary | Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks | baseline, 2 weeks, 12 weeks | |
| Secondary | Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks | baseline, 2 weeks, 12 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | baseline, 12 weeks | units on a scale | MEAN | |
| SECONDARY | Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks | baseline, 2 weeks, 12 weeks | pg/ml | MEAN | |
| SECONDARY | Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks | baseline, 2 weeks, 12 weeks | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estriol | Dryness Severity | 3.2 | Standard Deviation 2.3 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estradiol | Dryness Severity | 2.0 | Standard Deviation 3.3 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Placebo | Dryness Severity | 2.7 | Standard Deviation 2.7 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estriol | Dryness Bothersomeness | 2.3 | Standard Deviation 2.8 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estradiol | Dryness Bothersomeness | 2.1 | Standard Deviation 2.7 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Placebo | Dryness Bothersomeness | 3.6 | Standard Deviation 3.1 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estriol | Itching Severity | 1.4 | Standard Deviation 1.6 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estradiol | Itching Severity | 2.6 | Standard Deviation 2.9 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Placebo | Itching Severity | 1.9 | Standard Deviation 2.8 | units on a scale |
| Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12 | Estriol | Itching Bothersomeness | 1.3 | Standard Deviation 1.6 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estriol | 20 | |
| Overall Study | STARTED | Estradiol | 21 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | Estriol | 18 | |
| Overall Study | COMPLETED | Estradiol | 19 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Estriol | 2 | |
| Overall Study | NOT COMPLETED | Estradiol | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events9
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 | Red Bumpy Rash | Skin and subcutaneous tissue disorders | Estriol | 1 | 18 | 1 |
| other | Red Bumpy Rash | Skin and subcutaneous tissue disorders | Estradiol | 0 | 19 | 0 |
| other | Red Bumpy Rash | Skin and subcutaneous tissue disorders | Placebo | 0 | 19 | 0 |
| other | Vaginal Spotting | Reproductive system and breast disorders | Estriol | 1 | 18 | 1 |
| other | Vaginal Spotting | Reproductive system and breast disorders | Estradiol | 0 | 19 | 0 |
| other | Vaginal Spotting | Reproductive system and breast disorders | Placebo | 1 | 19 | 1 |
| other | Breast tenderness | Reproductive system and breast disorders | Estriol | 1 | 18 | 1 |
| other | Breast tenderness | Reproductive system and breast disorders | Estradiol | 0 | 19 | 0 |
| other | Breast tenderness | Reproductive system and breast disorders | Placebo | 0 | 19 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Estriol | ||
| Total, all-cause mortality | Estradiol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Estriol | 3 | 18 |
| Total, other adverse events | Estradiol | 0 | 19 |
| Total, other adverse events | Placebo | 1 | 19 |
| Total, serious adverse events | Estriol | 0 | 18 |
| Total, serious adverse events | Estradiol | 0 | 19 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR000135 | Mayo Clinic Center for Clinical and Translational Science (CCaTS) | KHOSLA, SUNDEEP | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2012 to 2015 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00816556
GET https://conductscience.org/api/trials/v1/NCT00816556/results?page=2