Clinical Trials Logo
  1. Home
  2. Vaginal Atrophy
  3. 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 — BLISSAFE  

Vaginal Atrophy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02413008
Study type Interventional
Source ITF Research Pharma, S.L.U.
Contact
Status Completed
Phase Phase 2
Start date October 16, 2015
Completion date February 10, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT06136975 - Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
Recruiting NCT04081805 - LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2) N/A
Completed NCT04039555 - Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER) N/A
Active, not recruiting NCT02704741 - Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments N/A
Completed NCT01975129 - A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin Phase 2
Completed NCT04735549 - Vulvovaginal Atrophy Correction Using Neodymium Laser N/A
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Completed NCT03063684 - Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus N/A
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Not yet recruiting NCT05483634 - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Completed NCT04717245 - Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment N/A
Completed NCT02937805 - Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes N/A
Completed NCT02967510 - Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy Phase 2
Not yet recruiting NCT02571127 - Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. Phase 4
Completed NCT00238732 - Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause Phase 3
Completed NCT03493126 - Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function Phase 4
Not yet recruiting NCT03238053 - Laser Treatment of Genito-urinary Syndrome in Women N/A
Terminated NCT01753102 - Efficacy and Safety Of Spil's Estradiol Vaginal Tablet Phase 3
Terminated NCT05627791 - Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman Phase 2/Phase 3
Completed NCT00429806 - DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy Phase 1