Trial · NCT03294538
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
NCT03294538, Phase 3, Completed, Actavis Inc.; results first posted 2019-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis. Trials, record NCT03294538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03294538
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
- NCT number
- NCT03294538
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 663 participants, actual
- Lead sponsor
- Actavis Inc.
- Conditions
- Atrophic Vaginitis
- Interventions
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- First posted
- 2017-09-27
- Last updated
- 2019-12-26
- Results first posted
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Up to Day 9 | Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder. |
| Primary | Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Up to Day 9 | Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. |
| Secondary | Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Up to Day 9 | The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder. |
| Secondary | Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Up to 9 months | The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Up to Day 9 | Participants who met I/E criteria, didn't develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn't miss \>1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Up to Day 9 | Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using Last Observation Carried Forward (LOCF). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Up to Day 9 | Participants who met I/E criteria, didn't develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn't miss \>1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Up to 9 months | Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using LOCF. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Generic Estradiol Vaginal Cream USP, 0.01% | 49 | Participants | ||
| Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Estrace Vaginal Cream USP, 0.01% | 44 | Participants | ||
| Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Generic Estradiol Vaginal Cream USP, 0.01% | 53 | Participants | ||
| Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Estrace Vaginal Cream USP, 0.01% | 53 | Participants | ||
| Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Vehicle Vaginal Cream | 0 | Participants | ||
| Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Generic Estradiol Vaginal Cream USP, 0.01% | 161 | Participants | ||
| Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Estrace Vaginal Cream USP, 0.01% | 153 | Participants | ||
| Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Generic Estradiol Vaginal Cream USP, 0.01% | 175 | Participants | ||
| Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Estrace Vaginal Cream USP, 0.01% | 169 | Participants | ||
| Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups | Vehicle Vaginal Cream | 80 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Generic Estradiol Vaginal Cream USP, 0.01% | 268 | |
| Overall Study | STARTED | Estrace Vaginal Cream USP, 0.01% | 262 | |
| Overall Study | STARTED | Vehicle Vaginal Cream | 133 | |
| Overall Study | Safety Population | Generic Estradiol Vaginal Cream USP, 0.01% | 267 | |
| Overall Study | Safety Population | Estrace Vaginal Cream USP, 0.01% | 262 | |
| Overall Study | Safety Population | Vehicle Vaginal Cream | 132 | |
| Overall Study | mITT Population | Generic Estradiol Vaginal Cream USP, 0.01% | 267 | |
| Overall Study | mITT Population | Estrace Vaginal Cream USP, 0.01% | 262 | |
| Overall Study | mITT Population | Vehicle Vaginal Cream | 132 | |
| Overall Study | PP Population | Generic Estradiol Vaginal Cream USP, 0.01% | 244 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events309
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 | Tachycardia | Cardiac disorders | Generic Estradiol Vaginal Cream USP, 0.01% | 1 | 267 | |
| other | Tachycardia | Cardiac disorders | Estrace Vaginal Cream USP, 0.01% | 0 | 262 | |
| other | Tachycardia | Cardiac disorders | Vehicle Vaginal Cream | 0 | 132 | |
| other | Ear pain | Ear and labyrinth disorders | Generic Estradiol Vaginal Cream USP, 0.01% | 0 | 267 | |
| other | Ear pain | Ear and labyrinth disorders | Estrace Vaginal Cream USP, 0.01% | 0 | 262 | |
| other | Ear pain | Ear and labyrinth disorders | Vehicle Vaginal Cream | 1 | 132 | |
| other | Retinal tear | Eye disorders | Generic Estradiol Vaginal Cream USP, 0.01% | 0 | 267 | |
| other | Retinal tear | Eye disorders | Estrace Vaginal Cream USP, 0.01% | 1 | 262 | |
| other | Retinal tear | Eye disorders | Vehicle Vaginal Cream | 0 | 132 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Generic Estradiol Vaginal Cream USP, 0.01% | 2 | 267 |
1 to 10 of 309Source ClinicalTrials.gov
See all 309 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Estradiol Vaginal Cream USP, 0.01% | 0 | 267 |
| Total, all-cause mortality | Estrace Vaginal Cream USP, 0.01% | 0 | 262 |
| Total, all-cause mortality | Vehicle Vaginal Cream | 0 | 132 |
| Total, other adverse events | Generic Estradiol Vaginal Cream USP, 0.01% | 63 | 267 |
| Total, other adverse events | Estrace Vaginal Cream USP, 0.01% | 74 | 262 |
| Total, other adverse events | Vehicle Vaginal Cream | 25 | 132 |
| Total, serious adverse events | Generic Estradiol Vaginal Cream USP, 0.01% | 0 | 267 |
| Total, serious adverse events | Estrace Vaginal Cream USP, 0.01% | 1 | 262 |
| Total, serious adverse events | Vehicle Vaginal Cream | 0 | 132 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01%: Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | Trial comparisons |
Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01%: Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups | 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/NCT03294538
GET https://conductscience.org/api/trials/v1/NCT03294538/events?page=2