Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Atrophy

Breast Neoplasms

Pathological Conditions, Anatomical

All Drugs and Chemicals

Hormones

Aromatase Inhibitors

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

estriol

Placebo

This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs) in the adjuvant setting and symptoms of vaginal atrophy.

This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study.

In the setting of postmenopausal hormone receptor positive breast cancer, treatment with aromatase inhibitors (AIs) is the most effective and well-studied therapy. Vaginal dryness is one of the most frequently reported symptom caused by this adjuvant therapy which may lead to a reduced adherence in breast cancer women.

This study will explore the safety of 0.005% estriol vaginal gel in this oncological context, to demonstrate that this medicinal product is a safe option to treat the vaginal atrophy caused by AIs, without a clinically relevant influence in gonadotropins or systemic estrogen levels.

The main objective is to evaluate the levels of Follicle Stimulating Hormone (FSH) after treatment with 0.005% estriol vaginal gel in hormone receptor-positive postmenopausal women with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs) in the adjuvant setting and symptoms of vaginal atrophy.

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

A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multi-Centre 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

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)

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)

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)

Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline

Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline.

Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline.

Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints

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

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

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

Changes in Symptoms of vaginal atrophy (vaginal dryness, dyspareunia and pruritus) at week 3 and week 12 vs baseline.

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 A Global Symptoms Score will be calculated by summing the intensities of all the three symptoms of vaginal atrophy in a certain time point, thus ranging between 0 and 9.

It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:

0 Absence. The sign 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

The signs evaluated Will be the following: vaginal mucosa with flattening of folds or thinning, dryness of the mucosa and Fragility of the mucosa.

It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:

0 Absence. The sign 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 A Total Signs Score will be calculated by summing the intensities of all the three signs of vaginal atrophy in a certain time point, thus ranging between 0 and 9.

Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula:

0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial).

Spanish Breast Cancer Research Group

ITF Research Pharma, S.L.U.

AE: Any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.

0.005% Estriol Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

Placebo

Placebo Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

estriol

Total

Age, Categorical

Age, Continuous

Female

Sex/Gender, Customized

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Sweden

Spain

Region of Enrollment

Concepción Nieto Magro

The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.

The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit.

The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.

Variation in Serum Levels of Follicle Stimulating Hormone (FSH)

Variation in serum levels of FSH at week 1

Variation in serum levels of FSH at week 3

Variation in serum levels of FSH at week 8

change from baseline to week 1

change from baseline to week 3

change from baseline to week 8

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

estriol: 0.005% estriol vaginal gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

Placebo: placebo vaginal gel

Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8

Change in serum levels of Luteinizing hormone (LH) from baseline to week 1

Change in serum levels of Luteinizing hormone (LH) from baseline to week 3

Change in serum levels of Luteinizing hormone (LH) from baseline to week 8

Change in serum levels of Luteinizing hormone (LH) from baseline to week 12

change from LH baseline to week 1

change from LH baseline to week 3

change from LH baseline to week 8

change from LH baseline to week 12

Variation in Serum Levels of Luteinizing Hormone (LH)

Change from baseline to week 1 in plasma levels of estriol

Change from baseline to week 3 in plasma levels of estriol

Change from baseline to week 8 in plasma levels of estriol

Change from baseline to week 12 in plasma levels of estriol

Change between baseline and week 1

Change between baseline and week 3

Change between baseline and week 8

Change between baseline and week 12

Variation in Plasma Levels of Estriol

Change from baseline to week 1 in plasma levels of estradiol.

Change from baseline to week 3 in plasma levels of estradiol.

Change in plasma levels of estradiol from baseline to week 8

Change in plasma levels of estradiol from baseline to week 12

Variation in Plasma Levels of Estradiol

Change in plasma levels of estrona from baseline to week 1

Change in plasma levels of estrona from baseline to week 3

Change in plasma levels of estrona from baseline to week 8

Change in plasma levels of estrona from baseline to week 12

Change from baseline to week 1

Change from baseline to week 12

Variation in Plasma Levels of Estrona

Change in pH between baseline and week 12

Change from baseline to Week 3

Change from baseline to Week 12

Changes in Vaginal pH Between Baseline and Week 3 and Week 12

Changes in dyspareunia from baseline to week 3

Changes in dyspareunia from baseline to week 12

Changes in Dyspareunia

Changes between baseline and week 3

Changes between baseline and week 12

Change in Pruritus or Itching From Baseline to Week 3 and Week 12

Changes in vaginal dryness from baseline to week 3

Changes in vaginal dryness from baseline to week 12

Changes in Vaginal Dryness

Changes in total score of symptoms of vaginal atrophy from baseline to week 3

Changes in total score of symptoms of vaginal atrophy from baseline to week 12

Changes in Total Score of Symptoms of Vaginal Atrophy

Changes in dryness of the mucosa between baseline and week 3

Changes in dryness of the mucosa betweeen baseline and week 12

Changes in Dryness of the Mucosa

Changes in dryness of the mucosa between baseline and week 12

Changes from baseline to week 3

Changes from baseline to week 12

Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]

Changes in Vaginal Mucosa With Flattening of Folds or Thinning

Change in total score of signs between week 3 and baseline

Change in total score of signs between week 12 and baseline

Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline

Change in maturation value from baseline to week 3

Change in maturation value from baseline to week 12

Spots Global Cancer Trial Database for estriol

Every month we try and update this database with for estriol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for estriol

Every month we try and update this database with for estriol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for estriol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.