Clinical Trials Logo

Clinical Trial Summary

Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.


Clinical Trial Description

Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.

This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02994342
Study type Interventional
Source Zambon SpA
Contact
Status Completed
Phase N/A
Start date October 2012
Completion date October 2015

See also
  Status Clinical Trial Phase
Not yet recruiting NCT01170195 - Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms Phase 1/Phase 2
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Completed NCT02937805 - Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes N/A
Recruiting NCT05913479 - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer N/A
Completed NCT03307044 - Fractional CO2 Laser Therapy for Survivors of Breast Malignancies N/A
Recruiting NCT03714581 - Laser Therapy Following Radiotherapy for Gynecological Cancer N/A
Completed NCT01948583 - Humectant Activity of a New Formulation of Gynomunal® Vaginalgel Phase 4
Completed NCT03178825 - Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause N/A
Completed NCT03372720 - Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors N/A
Not yet recruiting NCT06282614 - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer N/A
Completed NCT02176083 - Reproductive Health Survivorship Care Plan Pilot N/A
Completed NCT04908124 - A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants. Phase 3
Not yet recruiting NCT05156502 - To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser N/A
Completed NCT02638337 - Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause Phase 3
Not yet recruiting NCT02987647 - Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream Phase 4
Not yet recruiting NCT03782961 - Evaluation of Viscosity of a Vaginal Moisturizer Phase 4
Withdrawn NCT01724242 - Vaginal DHEA for Women After Breast Cancer Phase 2/Phase 3
Completed NCT01697345 - Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy Phase 0
Completed NCT02269826 - Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness N/A
Completed NCT05644444 - Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action N/A