Evaluating the effect of a non-hormonal vaginal gel on the cervix and vagina of HPV-positive wome

Not Applicable

Completed

• Conditions: Human papillomavirus infection; Infections and Infestations

• Registration Number: ISRCTN13043765
• Lead Sponsor: Gabinete Médico Velázquez S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-31
• Study Start: 2019-04-02
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

1. Sexually active women
2. 25 years of age and older
3. Attending a routine control gynecologic visit
4. Normal Papanicolaou smear and normal colposcopic findings
5. Diagnosis of HPV positivity by polymerase chain reaction (PCR)-based HPV DNA detection within 3 months before consultation.

Exclusion Criteria

1. Clinically relevant disorders of the immune system
2. Treatment with immunosuppressant agents
3. Abnormal vaginal bleeding (without diagnosis) within the 6 months prior to the screening visit
4. Symptomatic vulvovaginal infection
5. History of gynecologic cancer
6. Use of vaginal contraceptives or other vaginal hormonal treatments
7. Planned surgery preventing compliance with treatment
8. Current participation in a current clinical trials or in the previous 4 weeks
9. Fertile women not using effective contraceptive methods
10. Pregnant or breastfeeding
11. Contraindication for the use of Papilocare® or known allergies to some of its components.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The epithelization degree of the cervical mucosa was assessed by the investigator by standard colposcopy and rated using a 5-point Likert scale, where 5 was no ectopy, 4: mild (<25% of the external os), 3: moderate (25–50% of the external os), 2: severe (>50% of the external os) and 1: severe ectopy and bleeding. This variable was measured at baseline and 21 days.

Secondary Outcome Measures

Name	Time	Method
<br> The composition of bacterial communities was assessed by calculating three major ecological parameters, including the Chao1 richness index for abundance data (an estimate of a total community), the Pielou’s evenness index (to show how evenly the individuals in the community were distributed over different operational taxonomic units [OUT]) , and the Shannon biodiversity index (a combined parameter of richness and evenness) [34]. The Shannon biodiversity index was categorized as < 2 (low diversity), 2-3 (normal), and > 3 (high diversity). This variable was measured at baseline and 21 days.<br>