A Clinical Study of Vaginal Lubricant for Improvement of Vaginal Dryness

A Randomized Comparative, Open Label, 2 Arm, Phase III Clinical Study to Evaluate the Safety and Efficacy of Vaginal Lubricant for Improvement of Vaginal Dryness

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011142

Enrollment

Registered

2018-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N952- Postmenopausal atrophic vaginitis

Interventions

Intervention1: HVGL-051502: advised to apply a small amount of lubricant inside the vagina just before the sexual intercourse. Control Intervention1: HVGL-051502/A: advised to apply a small amount of

Eligibility

Inclusion criteria

Inclusion criteria: Women with active sex lives of at least one sexual intercourse in a week Women without a history of sensitivity to similar formulations Subjects willing to sign informed consent and follow the study procedure.

Exclusion criteria

Exclusion criteria: Women using other intra vaginal gel moisturizer, diagnosed with cancer, Women using hormone replacement therapy in the last 3 months, Absence of history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infection, Pregnant or lactating, women likely to become pregnant, Personal history of allergy and hypersensitivity to any product of feminine hygiene, severe systemic complications of viral infections, severe systemic illness like cardiovascular disorders, neurological disorders, renal disorders, autoimmune disorders,Not willing to sign informed consent form

Design outcomes

Primary

Measure	Time frame
Percentage of improvement of vaginal dryness symptoms. Change of Verbal Rating Scale (VRS) total score from baseline to the end of the study.To evaluate the differences from baseline to the end of the study of Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS-R) Timepoint: Visit 0- At entry visit, baseline Visit 1- At the end of Week 2 Visit 2- At the end of Week 4	—

Secondary

Measure	Time frame
Incidence of adverse events (AEs) Safety and Tolerability of the study drug and patient compliance to therapyTimepoint: Visit 0- At entry visit, baseline Visit 1- At the end of Week 2 Visit 2- At the end of Week 4	—

Countries

India

Contacts

Public ContactDr Maya Kamble

Sree Ayurved College and Hospital

maya_kamble@rediffmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026