Condition category
Urological and Genital Diseases
Date applied
18/07/2008
Date assigned
01/08/2008
Last edited
05/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr André Luiz Vergnanini

ORCID ID

Contact details

Rua Vicente Porto
660.
Barão Geraldo
Campinas
13085-080
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INC056-01

Study information

Scientific title

A phase III, single-blind, single-centre trial to assess efficacy and tolerability of genital mucosa after use of product INC056 in post-menopausal women

Acronym

Study hypothesis

This study is to confirm the safety, tolerability and efficacy of INC056 in post-menopausal female volunteers.

Hypothesis:
This treatment is expected to lower the vaginal pH in post-menopausal women and thus, to relieve local irritability and dryness of vagina.

Ethics approval

Ethical approval received from the Ethics Committee of Irmandade de Misericórdia de Campinas - Hospital Irmãos Penteado (Brazil) on the 10th December 2007

Study design

A phase III, single-centre, non-randomised, non-controlled, single-blind study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Local irritability and dryness of vagina

Intervention

Pre-trial visit:
Prior to interventions, written informed consent will be gained. Screening assessment, vaginal pH testing, gynaecological exam and interview will be performed. The dose is one disposable applicator full of INC056 product (approximately 4 grams), applied intravaginally at bedtime.

Volunteers will be instructed to administrate the product as following:
1. Once every 3 days during 30 days
2. A 7 days washout period
3. Once daily for next 14 days

Visits will be performed on days 15, 30, 37 and 53.

Intervention type

Drug

Phase

Phase III

Drug names

INC056

Primary outcome measures

Evaluate vaginal acidification after product use (lowering of vaginal pH) at all visits (baseline and days 14, 30, 37 and 52).

Secondary outcome measures

The following will be assessed at all visits (baseline and days 14, 30, 37 and 52):
1. Assessment of all adverse events reported
2. Assessment of vaginal dryness and/or sexual discomfort
3. Occurrence of recurrent vaginal infections in volunteers
4. Investigator's Global Assessment
5. Volunteer's Global Assessment
6. Assessment measured by acceptability questionnaire
7. Interruption of use due allergic reactions or irritability

Overall trial start date

01/10/2008

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy female volunteers aged between 40 and 65 years
2. Post-menopausal women
3. Vaginal pH of 5.0 or higher
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

65 volunteers

Participant exclusion criteria

1. Pregnancy or lactation
2. Skin disease at site of administration
3. Diabetes mellitus
4. Immunological insufficiency
5. Use of systemic corticoid, antibiotics or steroids
6. Use of immunosuppressive drugs
7. Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
8. Antifungal therapy within the last month at screening
9. History of infection at the site of drug administration
10. History of allergies to components of product
11. Other diseases or medications that could interfere with the research result or endanger the volunteer

Recruitment start date

01/10/2008

Recruitment end date

01/02/2009

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Vicente Porto, 660.
Campinas
13085-080
Brazil

Sponsor information

Organisation

Incrementha PD&I (Brazil)

Sponsor details

Av. Professor Lineu Prestes
2242
Prédio do Cietec - Sala 11
Cidade Universitária
São Paulo
05508-000
Brazil
+55 11 3039 8429
fernando.francisco@incrementha.com.br

Sponsor type

Industry

Website

http://www.incrementha.com.br

Funders

Funder type

Industry

Funder name

Incrementha PD&I (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes