NCT02413008|CompletedPhase 2ResultsDMC

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

BLISSAFE

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

ITF Research Pharma, S.L.U.ClinicalTrials.gov

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2 other identifiers

ITFE-2026-C102014-004517-84

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredApr 2015

StartedOct 2015

CompletionFeb 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach

2 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

April 1, 2015

Completed

8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed

6 months until next milestone

Study Start

First participant enrolled

October 16, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2017

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed

Last Updated

August 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

April 1, 2015

Results QC Date

August 8, 2018

Last Update Submit

June 21, 2019

Conditions

Vaginal Atrophy

Keywords

vaginal atrophybreast cancervaginal drynessaromatase inhibitor

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (15)

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
Variation in Serum Levels of Luteinizing Hormone (LH)
Change from baseline to week 1, week 3, week 8 and week 12
Variation in Plasma Levels of Estriol
Change from baseline to week 1, week 3, week 8 and week 12
Variation in Plasma Levels of Estradiol
Change from baseline to week 1, week 3, week 8 and week 12
Variation in Plasma Levels of Estrona
Change from baseline to week 1, week 3, week 8 and week 12
+10 more secondary outcomes

Study Arms (2)

0.005% estriol vaginal gel

EXPERIMENTAL

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

Drug: estriol

placebo vaginal gel

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

estriolDRUG

0.005% estriol vaginal gel

Also known as: Blissel (estriol), Gelistrol (estriol)

0.005% estriol vaginal gel

PlaceboDRUG

placebo vaginal gel

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent prior to beginning specific protocol procedures.
Patients must have histological confirmation of breast adenocarcinoma with stage I-IIIA, documented at a local pathology department.
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.
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.
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.
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.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Adequate bone marrow as defined by the following laboratory values:
Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L.
Platelets (plt) ≥ 100 x 109/L.
Hemoglobin (Hgb) ≥ 10 g/dl.
Patient has adequate organ function as defined by the following laboratory values:
Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN).
Bilirubin ≤ 1.5 × ULN.
Alkaline phosphatase ≤ 2 × ULN.
+2 more criteria

You may not qualify if:

Stage IIIB-IV breast cancer or bilateral breast cancer.
Treatment with any other current anti-tumoral therapy (chemotherapy, anti-Her2…etc) besides the NSAI. Pamidronate or Alendronate are permitted.
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.
Postmenopausal uterine bleeding. Vaginal bleeding of unknown etiology.
Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.
Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study.
Use of any hormone, natural (phytoestrogens) or herbal products for the treatment of menopausal symptoms within the last 3 months.
Current or previous history of thromboembolic disease or coagulopathies.
Severe cardiovascular or respiratory diseases in the previous 6 months.
Renal Impairment.
Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function).
Known human immunodeficiency virus infection.
Known hypersensitivity to NSAI.
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.

Contact the study team to confirm eligibility.