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

ISRCTN	ISRCTN64791295
DOI	https://doi.org/10.1186/ISRCTN64791295
Secondary identifying numbers	INC056-01

Submission date: 18/07/2008
Registration date: 01/08/2008
Last edited: 05/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr André Luiz Vergnanini
Scientific

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

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethical approval received from the Ethics Committee of Irmandade de Misericórdia de Campinas - Hospital Irmãos Penteado (Brazil) on the 10th December 2007
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	INC056
Primary outcome measure	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 study start date	01/10/2008
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	65 volunteers
Key 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
Key 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
Date of first enrolment	01/10/2008
Date of final enrolment	01/02/2009

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Vicente Porto, 660.

Campinas
13085-080
Brazil

Sponsor information

Incrementha PD&I (Brazil)
Industry

Av. Professor Lineu Prestes, 2242
Prédio do Cietec - Sala 11
Cidade Universitária
São Paulo
05508-000
Brazil

Phone	+55 11 3039 8429
Email	fernando.francisco@incrementha.com.br
Website	http://www.incrementha.com.br

Funders

Funder type

Industry

Incrementha PD&I (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan