Trial · NCT02413008

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting

NCT02413008, Phase 2, Completed, ITF Research Pharma, S.L.U.; results first posted 2019-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting. Trials, record NCT02413008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02413008

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Trial

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

Title: A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
NCT number: NCT02413008
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: ITF Research Pharma, S.L.U.
Conditions: Vaginal Atrophy
Interventions: estriol, Placebo
First posted: 2015-04-09
Last updated: 2019-08-05
Other registries' IDs: eudract:2014-004517-84
Results first posted: 2019-08-05

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Variation in Serum Levels of Follicle Stimulating Hormone (FSH)	from baseline to 12 weeks of treatment	Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)
Secondary	Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	Change from baseline to week 1, week 3 and week 8	Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation)
Secondary	Variation in Serum Levels of Luteinizing Hormone (LH)	Change from baseline to week 1, week 3, week 8 and week 12	Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH compare to natural physiological variability ( screening-baseline variation)
Secondary	Variation in Plasma Levels of Estriol	Change from baseline to week 1, week 3, week 8 and week 12	Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline
Secondary	Variation in Plasma Levels of Estradiol	Change from baseline to week 1, week 3, week 8 and week 12	Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline.
Secondary	Variation in Plasma Levels of Estrona	Change from baseline to week 1, week 3, week 8 and week 12	Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline.
Secondary	Changes in Vaginal pH Between Baseline and Week 3 and Week 12	week 3 and week 12 vs baseline	Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints
Secondary	Changes in Dyspareunia	week 3 and week 12 vs baseline	Changes in dyspareunia from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown 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 3. The symptom is stated as very irritating and severe in intensity
Secondary	Change in Pruritus or Itching From Baseline to Week 3 and Week 12	Change from baseline to week 3 and week 12	Change in pruritus or itching from baseline to week 3 and week 12 Each symptom will be scored 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 3. The symptom is stated as very irritating and severe in intensity
Secondary	Changes in Vaginal Dryness	week 3 and week 12 vs baseline	Change in vaginal dryness puntuation score from baseline to w3 and w12 Each symptom will be scored 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 3. The symptom is stated as very irritating and severe in intensity

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Variation in Serum Levels of Follicle Stimulating Hormone (FSH)	from baseline to 12 weeks of treatment	postmenopausal participants	mIU/ml	MEDIAN
SECONDARY	Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	Change from baseline to week 1, week 3 and week 8	postmenopausal women	mIU/ml	MEAN
SECONDARY	Variation in Serum Levels of Luteinizing Hormone (LH)	Change from baseline to week 1, week 3, week 8 and week 12	postmenopausal women	mIU/ml	MEDIAN
SECONDARY	Variation in Plasma Levels of Estriol	Change from baseline to week 1, week 3, week 8 and week 12	postmenopausal women	pg/mL	MEDIAN
SECONDARY	Variation in Plasma Levels of Estradiol	Change from baseline to week 1, week 3, week 8 and week 12	postmenopausal women	pg/mL	MEDIAN
SECONDARY	Variation in Plasma Levels of Estrona	Change from baseline to week 1, week 3, week 8 and week 12	postmenopausal women	pg/mL	MEDIAN
SECONDARY	Changes in Vaginal pH Between Baseline and Week 3 and Week 12	week 3 and week 12 vs baseline	postmenopausal women	units on a scale	MEAN
SECONDARY	Changes in Dyspareunia	week 3 and week 12 vs baseline	postmenopausal women	score on a scale	MEDIAN
SECONDARY	Change in Pruritus or Itching From Baseline to Week 3 and Week 12	Change from baseline to week 3 and week 12	postmenopausal women	units on a scale	MEDIAN
SECONDARY	Changes in Vaginal Dryness	week 3 and week 12 vs baseline	postmenopausal women	units on a scale	MEDIAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group80

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

Outcome	Group	Category	Value	Spread	Units
Variation in Serum Levels of Follicle Stimulating Hormone (FSH)	0.005% Estriol Vaginal Gel		-2.8	Inter-Quartile Range -13.1 to 7.4	mIU/ml
Variation in Serum Levels of Follicle Stimulating Hormone (FSH)	Placebo Vaginal Gel		1.4	Inter-Quartile Range -5.4 to 15.7	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	0.005% Estriol Vaginal Gel	change from baseline to week 1	-4.8	Inter-Quartile Range -11.6 to 2.6	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	Placebo Vaginal Gel	change from baseline to week 1	4.2	Inter-Quartile Range -7.8 to 7.3	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	0.005% Estriol Vaginal Gel	change from baseline to week 3	-4.2	Inter-Quartile Range -12.0 to 3.5	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	Placebo Vaginal Gel	change from baseline to week 3	-0.9	Inter-Quartile Range -4.0 to 2.3	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	0.005% Estriol Vaginal Gel	change from baseline to week 8	-2.6	Inter-Quartile Range -10.1 to 7.9	mIU/ml
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8	Placebo Vaginal Gel	change from baseline to week 8	5.2	Inter-Quartile Range -11.8 to 9	mIU/ml
Variation in Serum Levels of Luteinizing Hormone (LH)	0.005% Estriol Vaginal Gel	change from LH baseline to week 1	-0.6	Inter-Quartile Range -3.7 to 2.8	mIU/ml
Variation in Serum Levels of Luteinizing Hormone (LH)	Placebo Vaginal Gel	change from LH baseline to week 1	0.2	Inter-Quartile Range -1.8 to 8.1	mIU/ml

1 to 10 of 80Source ClinicalTrials.gov

See all 80 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 Vaginal Gel	50
Overall Study	STARTED	Placebo Vaginal Gel	11
Overall Study	COMPLETED	0.005% Estriol Vaginal Gel	43
Overall Study	COMPLETED	Placebo Vaginal Gel	9
Overall Study	NOT COMPLETED	0.005% Estriol Vaginal Gel	7
Overall Study	NOT COMPLETED	Placebo Vaginal Gel	2

Source ClinicalTrials.gov

Adverse events4

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	Urinary tract infection	Infections and infestations	0.005% Estriol Vaginal Gel	3	50
other	Urinary tract infection	Infections and infestations	Placebo Vaginal Gel	1	11
serious	Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0.005% Estriol Vaginal Gel	1	50
serious	Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo Vaginal Gel	0	11

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.005% Estriol Vaginal Gel	0	50
Total, all-cause mortality	Placebo Vaginal Gel	0	11
Total, other adverse events	0.005% Estriol Vaginal Gel	3	50
Total, other adverse events	Placebo Vaginal Gel	1	11
Total, serious adverse events	0.005% Estriol Vaginal Gel	1	50
Total, serious adverse events	Placebo Vaginal Gel	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32459035	DERIVED

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 Vaginal Gel vs Placebo Vaginal Gel: deaths from any cause	Trial comparisons
0.005% Estriol Vaginal Gel vs Placebo Vaginal Gel: 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.

GET https://conductscience.org/api/trials/v1/NCT02413008

GET https://conductscience.org/api/trials/v1/NCT02413008/results?page=2

API reference For AI assistants