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Trial record 12 of 198 for:    Vaginal Cancer: Clinical Trials

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)

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ClinicalTrials.gov Identifier: NCT02413008
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Spanish Breast Cancer Research Group
Information provided by (Responsible Party):
ITF Research Pharma, S.L.U.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vaginal Atrophy Drug: estriol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : February 10, 2017
Actual Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Estriol

Arm Intervention/treatment
Experimental: 0.005% estriol 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
Drug: estriol
Other Names:
  • Blissel (estriol)
  • Gelistrol (estriol)

Placebo Comparator: placebo 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
Drug: Placebo



Primary Outcome Measures :
  1. Variation in serum levels of FSH [ Time Frame: from baseline to 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Variation in serum levels of FSH [ Time Frame: different time points compared to baseline (weeks 1, 3 and 8) ]
  2. Variation in serum levels of Luteinizing hormone (LH) and plasma levels of estriol, estradiol and estrone [ Time Frame: different time points compared to baseline (weeks 1, 3, 8 and 12) ]
  3. Adverse Events [ Time Frame: baseline, weeks 1, 3, 8 and 12) ]
  4. Changes in vaginal dryness [ Time Frame: week 3 and week 12 vs baseline ]
  5. Changes in pruritus or itching [ Time Frame: week 3 and week 12 vs baseline ]
  6. Changes in dyspareunia [ Time Frame: week 3 and week 12 vs baseline ]
  7. Changes in vaginal mucosa with flattening of folds or thinning [ Time Frame: week 3 and week 12 vs baseline ]
  8. Changes in dryness of the mucosa [ Time Frame: week 3 and week 12 vs baseline ]
  9. Changes in fragility of the mucosa [ Time Frame: week 3 and week 12 vs baseline ]
  10. Changes in vaginal maturation value [ Time Frame: week 3 and week 12 vs baseline ]
  11. Changes in vaginal pH [ Time Frame: week 3 and week 12 vs baseline ]
  12. Changes in sexual function measured by the Female Sexual Function Index (FSFI) [ Time Frame: week 3 and week 12 vs baseline ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413008


Locations
Spain
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
L´Hospitalet de Llobregat, Barcelona, Spain, 08908
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
A Coruña, Spain, 15006
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
Jaén, Spain, 23007
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
Madrid, Spain, 28050
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
Valencia, Spain, 46010
Sweden
For additional information regarding investigative sites for this trial, contact ITF Research Pharma S.L.U.
Stockholm, Sweden, 171 77
Sponsors and Collaborators
ITF Research Pharma, S.L.U.
Spanish Breast Cancer Research Group

Responsible Party: ITF Research Pharma, S.L.U.
ClinicalTrials.gov Identifier: NCT02413008     History of Changes
Other Study ID Numbers: ITFE-2026-C10
2014-004517-84 ( EudraCT Number )
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Hormones
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists