Trial · NCT02995694

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

NCT02995694, Phase 3, Completed, Alvogen Pine Brook LLC; results first posted 2021-12-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis. Trials, record NCT02995694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02995694

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
NCT number: NCT02995694
Status: Completed
Phases: Phase 3
Enrollment: 535 participants, actual
Lead sponsor: Alvogen Pine Brook LLC
Conditions: Atrophic Vaginitis
Interventions: Estradiol, Placebos, Reference
First posted: 2016-12-16
Last updated: 2021-12-01
Results first posted: 2021-12-01

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Vaginal Cytology	Day 8	Number of patients in PP population identified as responders at end of the study.
Secondary	Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy	Day 8	Number of participants with the most bothersome vulvar and/or vaginal atrophy symptom treatment success at end of study. A "Treatment Success" was defined as a score of 0 or 1 at Day 8 (maximum Day 10) for the symptom identified at baseline as the most bothersome. This evaluation was based on patient self-assessed symptoms of VVA on a scale of 0 to 3 where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Vaginal Cytology	Day 8		participants	NUMBER
SECONDARY	Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy	Day 8		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Vaginal Cytology	Test	29	participants
Vaginal Cytology	Reference.	19	participants
Vaginal Cytology	Placebos	0	participants
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy	Estradiol Vaginal Cream	115	Participants
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy	Reference	114	Participants
Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy	Placebo	0	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Test	215
Overall Study	STARTED	Reference.	211
Overall Study	STARTED	Placebos	109
Overall Study	COMPLETED	Test	181
Overall Study	COMPLETED	Reference.	183
Overall Study	COMPLETED	Placebos	94
Overall Study	NOT COMPLETED	Test	34
Overall Study	NOT COMPLETED	Reference.	28
Overall Study	NOT COMPLETED	Placebos	15

Source ClinicalTrials.gov

Adverse events12

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
other	Gastrointestinal	Gastrointestinal disorders	Test	36	215
other	Gastrointestinal	Gastrointestinal disorders	Reference.	36	211
other	Gastrointestinal	Gastrointestinal disorders	Placebos	20	109
other	Breast Tenderness	Reproductive system and breast disorders	Test	36	215
other	Breast Tenderness	Reproductive system and breast disorders	Reference.	37	211
other	Breast Tenderness	Reproductive system and breast disorders	Placebos	5	109
other	Nervous System Disorders	Nervous system disorders	Test	13	215
other	Nervous System Disorders	Nervous system disorders	Reference.	19	211
other	Nervous System Disorders	Nervous system disorders	Placebos	5	109
other	Psychiatric disorders	Psychiatric disorders	Test	3	215

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test	0	215
Total, all-cause mortality	Reference.	0	211
Total, all-cause mortality	Placebos	0	109
Total, other adverse events	Test	88	215
Total, other adverse events	Reference.	85	211
Total, other adverse events	Placebos	30	109
Total, serious adverse events	Test	0	215
Total, serious adverse events	Reference.	0	211
Total, serious adverse events	Placebos	0	109

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02995694

GET https://conductscience.org/api/trials/v1/NCT02995694/registered

API reference For AI assistants