Trial · NCT02195986

A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis

NCT02195986, Phase 3, Completed, Mylan Pharmaceuticals Inc; results first posted 2017-09-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis. Trials, record NCT02195986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195986

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Trial

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

Title: A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
NCT number: NCT02195986
Status: Completed
Phases: Phase 3
Enrollment: 366 participants, actual
Lead sponsor: Mylan Pharmaceuticals Inc
Conditions: Atrophic Vaginitis
Interventions: Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream, Placebo Vaginal Cream
First posted: 2014-07-21
Last updated: 2022-03-09
Results first posted: 2017-09-06

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	Study Day 8	Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient 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.
Primary	Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	Study Day 8	Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8. A responder was defined as a patient 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.
Secondary	Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	Day 8	Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.
Secondary	Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	Day 8	Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.

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	Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	Study Day 8	The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	Study Day 8	The Intent-to-treat (ITT) population was used for the comparison of active treatments versus placebo analysis which consisted of all randomized subjects that used at least one dose of Test, Reference or Placebo and returned for at least one post-baseline visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	Day 8	The Per Protocol population was used for the secondary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed secondary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	Day 8	The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of Estradiol Vaginal Cream, Estrace®, or Placebo and returned for at least one post-baseline visit	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	Value	Units
Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	Estradiol Vaginal Cream	42	Participants
Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	Estrace® 0.01% Cream	45	Participants
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	Estradiol Vaginal Cream	49	Participants
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	Estrace® 0.01% Cream	51	Participants
Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo	Placebo Vaginal Cream	1	Participants
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	Estradiol Vaginal Cream	72	Participants
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	Estrace® 0.01% Cream	63	Participants
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	Estradiol Vaginal Cream	82	Participants
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	Estrace® 0.01% Cream	77	Participants
Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo	Placebo Vaginal Cream	33	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Estradiol Vaginal Cream	146
Overall Study	STARTED	Estrace® 0.01% Cream	147
Overall Study	STARTED	Placebo Vaginal Cream	73
Overall Study	COMPLETED	Estradiol Vaginal Cream	143
Overall Study	COMPLETED	Estrace® 0.01% Cream	142
Overall Study	COMPLETED	Placebo Vaginal Cream	71
Overall Study	NOT COMPLETED	Estradiol Vaginal Cream	3
Overall Study	NOT COMPLETED	Estrace® 0.01% Cream	5
Overall Study	NOT COMPLETED	Placebo Vaginal Cream	2

Source ClinicalTrials.gov

Adverse events27

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	Abdominal Pain	Gastrointestinal disorders	Estradiol Vaginal Cream	12	146	13
other	Abdominal Pain	Gastrointestinal disorders	Estrace® 0.01% Cream	17	144	22
other	Abdominal Pain	Gastrointestinal disorders	Placebo Vaginal Cream	0	72	0
other	Vulvovaginal Pruritus	Reproductive system and breast disorders	Estradiol Vaginal Cream	9	146	10
other	Vulvovaginal Pruritus	Reproductive system and breast disorders	Estrace® 0.01% Cream	2	144	2
other	Vulvovaginal Pruritus	Reproductive system and breast disorders	Placebo Vaginal Cream	2	72	2
other	Headache	Nervous system disorders	Estradiol Vaginal Cream	9	146	11
other	Headache	Nervous system disorders	Estrace® 0.01% Cream	4	144	4
other	Headache	Nervous system disorders	Placebo Vaginal Cream	4	72	4
other	Breast Tenderness	Reproductive system and breast disorders	Estradiol Vaginal Cream	2	146	2

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Estradiol Vaginal Cream	0	146
Total, all-cause mortality	Estrace® 0.01% Cream	0	144
Total, all-cause mortality	Placebo Vaginal Cream	0	72
Total, other adverse events	Estradiol Vaginal Cream	31	146
Total, other adverse events	Estrace® 0.01% Cream	27	144
Total, other adverse events	Placebo Vaginal Cream	8	72
Total, serious adverse events	Estradiol Vaginal Cream	1	146
Total, serious adverse events	Estrace® 0.01% Cream	0	144
Total, serious adverse events	Placebo Vaginal Cream	0	72

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
Estradiol Vaginal Cream vs Estrace® 0.01% Cream: Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence	Trial comparisons
Estradiol Vaginal Cream vs Estrace® 0.01% Cream: Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence	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.

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/NCT02195986

GET https://conductscience.org/api/trials/v1/NCT02195986/events?page=2

API reference For AI assistants