NCT02413008 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-08-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Variation in Serum Levels of Follicle Stimulating Hormone (FSH)

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outcome · POSTED

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

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outcome · POSTED

Variation in Serum Levels of Luteinizing Hormone (LH)

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outcome · POSTED

Variation in Plasma Levels of Estriol

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outcome · POSTED

Variation in Plasma Levels of Estradiol

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outcome · POSTED

Variation in Plasma Levels of Estrona

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outcome · POSTED

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

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outcome · POSTED

Changes in Dyspareunia

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outcome · POSTED

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

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outcome · POSTED

Changes in Vaginal Dryness

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outcome · POSTED

Changes in Total Score of Symptoms of Vaginal Atrophy

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outcome · POSTED

Changes in Dryness of the Mucosa

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outcome · POSTED

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

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outcome · POSTED

Changes in Vaginal Mucosa With Flattening of Folds or Thinning

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outcome · POSTED

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

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outcome · POSTED

Changes in Vaginal Maturation Value

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Written informed consent prior to beginning specific protocol procedures. 2. Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department. 3. The breast tumors must be estrogen-receptor positive and/or progesterone receptor positive (≥1% of stained tumor cells by Immunohistochemistry (IHC) as determined by the local laboratory) with any Human Epidermal Growth Factor Receptor 2(HER2) status. 4. Postmenopausal status defined as: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 Milli-international units per milliliter (mIU/ml) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 5. Patient must be receiving the non-steroidal aromatase inhibitors anastrozole or letrozole as breast cancer treatment in the adjuvant setting for a minimum of 6 months. 6. Women suffering from moderate to severe vaginal dryness according to the FDA guidelines for drug development in postmenopausal women (Center for Drug Evaluation and Research, (CDER) Jan 2003). A moderate symptom will be considered if the symptom is present, bothersome and annoying, and a severe symptom will be considered if the symptom is present, bothersome and annoying, and interferes with the normal patient activity. 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 8. Adequate bone marrow as defined by the following laboratory values: 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L. 2. Platelets (plt) ≥ 100 x 109/L. 3. Hemoglobin (Hgb) ≥ 10 g/dl. 9. Patient has adequate organ function as defined by the following laboratory values: 1. Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN). 2. Bilirubin ≤ 1.5 × ULN. 3. Alkaline phosphatase ≤ 2 × ULN. 4. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 × ULN. 10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: 1. Stage IIIB-IV breast cancer or bilateral breast cancer. 2. Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2…etc) besides the NSAI. Pamidronate or Alendronate are permitted. 3. Prior history of other malignancy within 5 years of study entry, aside from non-melanoma skin cancer or carcinoma-in-situ of the uterine cervix adequately treated. 4. Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology. 5. Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound. 6. Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study. 7. Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 3 months. 8. Current or previous history of thromboembolic disease or coagulopathies. 9. Severe cardiovascular or respiratory diseases in the previous 6 months. 10. Renal Impairment. 11. Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function). 12. Known human immunodeficiency virus infection. 13. Known hypersensitivity to NSAI. 14. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 15. Previous investigational treatment for any condition or participation in any clinical trial within 4 weeks of inclusion date.
healthy Volunteers: false
sex: FEMALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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
intervention Names
Drug: estriol
label
0.005% estriol vaginal gel
type
EXPERIMENTAL
description
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
intervention Names
Drug: Placebo
label
placebo vaginal gel
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
0.005% estriol vaginal gel
description
0.005% estriol vaginal gel
name
estriol
other Names
Blissel (estriol)
Gelistrol (estriol)
type
DRUG
arm Group Labels
placebo vaginal gel
description
placebo vaginal gel
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 61
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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)
measure
Variation in Serum Levels of Follicle Stimulating Hormone (FSH)
time Frame
from baseline to 12 weeks of treatment

secondary Outcomes

description
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)
measure
Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8
time Frame
Change from baseline to week 1, week 3 and week 8
description
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)
measure
Variation in Serum Levels of Luteinizing Hormone (LH)
time Frame
Change from baseline to week 1, week 3, week 8 and week 12
description
Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline
measure
Variation in Plasma Levels of Estriol
time Frame
Change from baseline to week 1, week 3, week 8 and week 12
description
Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline.
measure
Variation in Plasma Levels of Estradiol
time Frame
Change from baseline to week 1, week 3, week 8 and week 12
description
Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline.
measure
Variation in Plasma Levels of Estrona
time Frame
Change from baseline to week 1, week 3, week 8 and week 12
description
Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints
measure
Changes in Vaginal pH Between Baseline and Week 3 and Week 12
time Frame
week 3 and week 12 vs baseline
description
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
measure
Changes in Dyspareunia
time Frame
week 3 and week 12 vs baseline
description
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
measure
Change in Pruritus or Itching From Baseline to Week 3 and Week 12
time Frame
Change from baseline to week 3 and week 12
description
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
measure
Changes in Vaginal Dryness
time Frame
week 3 and week 12 vs baseline
description
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.
measure
Changes in Total Score of Symptoms of Vaginal Atrophy
time Frame
week 3 and week 12 vs baseline
description
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
measure
Changes in Dryness of the Mucosa
time Frame
week 3 and week 12 vs baseline
description
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
measure
Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]
time Frame
from baseline to week 3 and 12

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

references

citation
Sanchez-Rovira P, Hirschberg AL, Gil-Gil M, Bermejo-De Las Heras B, Nieto-Magro C. A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter 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. Oncologist. 2020 Dec;25(12):e1846-1854. doi: 10.1634/theoncologist.2020-0417. Epub 2020 Jun 9.
pmid
32459035
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice