Clinical Trials Logo
  1. Home
  2. Vaginal Atrophy
  3. NCT03770065
  4. Details
NCT03770065 Clinical Trial

Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Vaginal Atrophy Clinical Trial

Official title:
A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03770065
Other study ID # VML-0001-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 19, 2018
Est. completion date April 8, 2020

Study information
Verified date October 2020
Source Viramal Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date April 8, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria:

- be greater than 45 years

- no positive findings on screening gynaecological examination

- negative smear test within the last 5 years

Exclusion Criteria:

- has signs of vaginal infection

- has evidence of alcohol abuse

- has used hormonal replacement therapy in three months prior to study entry

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• VML-0001
Medical device

Locations
Country Name City State
United States Medical Affiliated Research Center, Inc. (MARC) Huntsville Alabama

Sponsors (1)
Lead Sponsor Collaborator
Viramal Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH. The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits. 7-14 days
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 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