Trial · NCT03332303

Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy

NCT03332303, Phase 3, Completed, Prasco LLC; results first posted 2024-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy. Trials, record NCT03332303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03332303

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Trial

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

Title: Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
NCT number: NCT03332303
Status: Completed
Phases: Phase 3
Enrollment: 540 participants, actual
Lead sponsor: Prasco LLC
Conditions: Vulvar and Vaginal Atrophy
Interventions: Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
First posted: 2017-11-06
Last updated: 2024-05-30
Results first posted: 2024-05-30

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	The Primary Efficacy Endpoint	Study Day 8 or Study Day 9	The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % 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.
Secondary	The Secondary Efficacy Endpoint	Study Day 8 or Study Day 9	The secondary efficacy endpoint is the number of participants in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 8 or Day 9. A "Treatment Success" is defined as a score of 0 or 1 on Day 8 or Day 9 for the symptom identified at baseline as the most bothersome. This evaluation will be based on (one) participant self-assessed symptom of VVA (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, or vaginal pain associated with sexual activity) on a scale of 0 to 3 where 0 = none and 3 = severe. Evaluation of vaginal bleeding during sexual activity will be based on a score of 1 (presence) if it is identified by the participant as the most bothersome symptom at baseline and a score of 0 (absent) on Day 8 or Day 9.
Other	Duration of Post-menopausal Status (Years)	Visit 1 (Day - 28 to Day -1)	Baseline Characteristic for Participants who reported Natural Cause for Menopause (Total n = 373 patients) with mean and standard deviation (SD) evaluated per Arm/Group at Visit 1 (Day -28 to Day -1) during Medical History and Demographics Screening

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	The Primary Efficacy Endpoint	Study Day 8 or Study Day 9	Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)	participants	NUMBER
SECONDARY	The Secondary Efficacy Endpoint	Study Day 8 or Study Day 9	Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)	participants	NUMBER
OTHER_PRE_SPECIFIED	Duration of Post-menopausal Status (Years)	Visit 1 (Day - 28 to Day -1)	Participants who reported Natural Cause for Menopause during Medical History and Demographics Screening	years	MEAN

Source ClinicalTrials.gov

Results by group13

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

Outcome	Group	Category	Value	Units
The Primary Efficacy Endpoint	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	Equivalence: PP Population	49	participants
The Primary Efficacy Endpoint	Active Comparator: Estrace® Cream	Equivalence: PP Population	59	participants
The Primary Efficacy Endpoint	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	Superiority: mITT Population	52	participants
The Primary Efficacy Endpoint	Active Comparator: Estrace® Cream	Superiority: mITT Population	63	participants
The Primary Efficacy Endpoint	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	Superiority: mITT Population	1	participants
The Secondary Efficacy Endpoint	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	Equivalence: PP Population	112	participants
The Secondary Efficacy Endpoint	Active Comparator: Estrace® Cream	Equivalence: PP Population	116	participants
The Secondary Efficacy Endpoint	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	Superiority: mITT Population	122	participants
The Secondary Efficacy Endpoint	Active Comparator: Estrace® Cream	Superiority: mITT Population	127	participants
The Secondary Efficacy Endpoint	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	Superiority: mITT Population	63	participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	215
Overall Study	STARTED	Active Comparator: Estrace® Cream	216
Overall Study	STARTED	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	109
Overall Study	Safety Population	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	215
Overall Study	Safety Population	Active Comparator: Estrace® Cream	216
Overall Study	Safety Population	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	109
Overall Study	Modified Intention to Treat (mITT) Population	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	214
Overall Study	Modified Intention to Treat (mITT) Population	Active Comparator: Estrace® Cream	213
Overall Study	Modified Intention to Treat (mITT) Population	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	109
Overall Study	Per Protocol (PP) Population	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	196

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events285

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	Vertigo Positional	Ear and labyrinth disorders	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	1	215
other	Vertigo Positional	Ear and labyrinth disorders	Active Comparator: Estrace® Cream	0	216
other	Vertigo Positional	Ear and labyrinth disorders	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	0	109
other	Abdominal Discomfort	Gastrointestinal disorders	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	1	215
other	Abdominal Discomfort	Gastrointestinal disorders	Active Comparator: Estrace® Cream	1	216
other	Abdominal Discomfort	Gastrointestinal disorders	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	0	109
other	Abdominal distention	Gastrointestinal disorders	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	6	215
other	Abdominal distention	Gastrointestinal disorders	Active Comparator: Estrace® Cream	5	216
other	Abdominal distention	Gastrointestinal disorders	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	0	109
other	Abdominal pain	Gastrointestinal disorders	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	7	215

1 to 10 of 285Source ClinicalTrials.gov

See all 285 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	0	215
Total, all-cause mortality	Active Comparator: Estrace® Cream	0	216
Total, all-cause mortality	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	0	109
Total, other adverse events	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	66	215
Total, other adverse events	Active Comparator: Estrace® Cream	59	216
Total, other adverse events	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	23	109
Total, serious adverse events	Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)	0	215
Total, serious adverse events	Active Comparator: Estrace® Cream	1	216
Total, serious adverse events	Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream	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/NCT03332303

GET https://conductscience.org/api/trials/v1/NCT03332303/events?page=2

API reference For AI assistants