Trial · NCT04574999

Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.

NCT04574999, Phase 3, Completed, Italfarmaco S.A; results first posted 2020-12-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy. Trials, record NCT04574999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04574999

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Trial

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

Title: Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
NCT number: NCT04574999
Status: Completed
Phases: Phase 3
Enrollment: 167 participants, actual
Lead sponsor: Italfarmaco S.A
Conditions: Vaginal Atrophy
Interventions: Estriol, Placebo
First posted: 2020-10-05
Last updated: 2020-12-11
Results first posted: 2020-12-11

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment	At week 12/Early withdrawal	Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree.
Secondary	Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period	At week 12 /early withdrawal	As a consequence of reduced estrogen levels, the vaginal mucosa occurs loses its rugosity, its thickness decreases, and it becomes pale and friable. The production of glycogen decreases, which determines vaginal pH alkalinization.
Secondary	Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	At baseline and at 12 weeks / early withdrawal	Signs and symptoms of vaginal atrophy are: vaginal dryness, pruritus or itching, burning, dyspareunia, dysuria. For each of these symptoms the subject indicates one the following status: present, absent, missing. Symptoms of vaginal atrophy were scored by the patients in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient's 3. The symptom is very irritating and severe in intensity Signs of vaginal atrophy were evaluated by the investigator and scored on a numerical scale as shown below: 0 Absence. The symptom is not present 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration
Secondary	Change From Baseline to Week 3 in Maturation Value (MV) After 3 Weeks of Treatment	At week 3/ early withdrawal	Maturation value (MV) is a cytologic parameter indicative of the degree of atrophy of the vaginal mucosa. This variable is a quantitative parameter indicative of the cytological status of the vaginal epithelium. The number of parabasal, intermediate and superficial cells was calculated from 300 consecutive cells of the samples of vaginal cytology, and the percentages of each type of cells obtained. The Maturation Value was obtained based on the following formula: 0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial). The higher the value, the higher the maturation degree.
Secondary	Change From Baseline to Week 3 of the Vaginal pH After the 3-week Observation Period	At week 3 / early withdrawal	As a consequence of reduced estrogen levels, the vaginal mucosa occurs loses its rugosity, its thickness decreases, and it becomes pale and friable. The production of glycogen decreases, which determines vaginal pH alkalinization.
Secondary	Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period	At 3 weeks	Signs and symptoms of vaginal atrophy are: vaginal dryness, pruritus or itching, burning, dyspareunia, dysuria. For each of these symptoms the subject indicates one the following status: present, absent, missing. Symptoms of vaginal atrophy were scored by the patients in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient's 3. The symptom is very irritating and severe in intensity Signs of vaginal atrophy were evaluated by the investigator and scored on a numerical scale as shown below: 0 Absence. The symptom is not present 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment	At week 12/Early withdrawal	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	vaginal health index	MEAN
SECONDARY	Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period	At week 12 /early withdrawal	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	pH units	MEAN
SECONDARY	Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	At baseline and at 12 weeks / early withdrawal	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline to Week 3 in Maturation Value (MV) After 3 Weeks of Treatment	At week 3/ early withdrawal	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	vaginal health index	MEAN
SECONDARY	Change From Baseline to Week 3 of the Vaginal pH After the 3-week Observation Period	At week 3 / early withdrawal	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	pH units	MEAN
SECONDARY	Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period	At 3 weeks	Intention-to-treat population (ITT): all randomized women that received at least one dose of the study drug (Estriol gel vaginal 0.005% or placebo) after the randomization.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group128

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment	0.005% Estriol Group		26.9	Standard Deviation 23.33	vaginal health index
Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment	Placebo Group		3.2	Standard Deviation 16.48	vaginal health index
Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period	0.005% Estriol Group		-1.2	Standard Deviation 1.4	pH units
Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period	Placebo Group		-0.4	Standard Deviation 1.2	pH units
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	0.005% Estriol Group	Vaginal dryness - Baseline - present	114		Participants
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	Placebo Group	Vaginal dryness - Baseline - present	53		Participants
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	0.005% Estriol Group	Vaginal dryness - Baseline - absent	0		Participants
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	Placebo Group	Vaginal dryness - Baseline - absent	0		Participants
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	0.005% Estriol Group	Vaginal dryness - Baseline - missing	0		Participants
Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	Placebo Group	Vaginal dryness - Baseline - missing	0		Participants

1 to 10 of 128Source ClinicalTrials.gov

See all 128 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	0.005% Estriol Group	114
Overall Study	STARTED	Placebo Group	53
Overall Study	COMPLETED	0.005% Estriol Group	105
Overall Study	COMPLETED	Placebo Group	48
Overall Study	NOT COMPLETED	0.005% Estriol Group	9
Overall Study	NOT COMPLETED	Placebo Group	5

Source ClinicalTrials.gov

Adverse events166

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	Urinary tract infection	Infections and infestations	0.005% Estriol Group	3	114	3
other	Urinary tract infection	Infections and infestations	Placebo Group	2	53	2
other	Nasopharyngitis	Infections and infestations	0.005% Estriol Group	1	114	1
other	Nasopharyngitis	Infections and infestations	Placebo Group	2	53	2
other	Candidiasis	Infections and infestations	0.005% Estriol Group	2	114	2
other	Candidiasis	Infections and infestations	Placebo Group	0	53	0
other	Cystitis	Infections and infestations	0.005% Estriol Group	0	114	0
other	Cystitis	Infections and infestations	Placebo Group	2	53	2
other	Influenza	Infections and infestations	0.005% Estriol Group	1	114	1
other	Influenza	Infections and infestations	Placebo Group	1	53	1

1 to 10 of 166Source ClinicalTrials.gov

See all 166 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.005% Estriol Group	0	114
Total, all-cause mortality	Placebo Group	0	53
Total, other adverse events	0.005% Estriol Group	50	114
Total, other adverse events	Placebo Group	20	53
Total, serious adverse events	0.005% Estriol Group	1	114
Total, serious adverse events	Placebo Group	0	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22914208	RESULT

Source PubMed

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
0.005% Estriol Group vs Placebo Group: deaths from any cause	Trial comparisons
0.005% Estriol Group vs Placebo Group: serious adverse events	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.

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