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

Vaginal Atrophy Clinical Trial

Official title:
A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo Controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy

Clinical Trial Summary

A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.

Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the lower urinary tract. As these alterations frequently affect the quality of life of postmenopausal women, it is important for doctors to detect their presence and offer treatment options. Estrogen therapy is the most effective treatment of moderate to severe symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen compared with oral therapy; the local route also minimize systemic adverse effects. The search for therapeutic alternatives which may present improvements in relation to the current products has been encouraged.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02967510
Study type Interventional
Source ITF Research Pharma, S.L.U.
Contact
Status Completed
Phase Phase 2
Start date October 2016
Completion date May 2018
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
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 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 Phase 2
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