Condition category
Infections and Infestations
Date applied
11/10/2012
Date assigned
24/10/2012
Last edited
24/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims?
Bacterial vaginosis (BV) is a common condition that affects almost one third of childbearing age women. The cause of BV is still unclear, but currently it is considered to be characterized by depletion of Lactobacillus spp. and an intense increase of vaginal anaerobic bacteria leading to a replacement of Lactobacilli and an increase in vaginal pH. The study aimed to evaluate the potential effect of vitamin C in preventing BV relapses in patients previously cured after a BV episode.

Who can participate?
Out-patient women, aged between 18 and 50 years, with recurrent bacterial vaginosis (BV).

What does the study involve?
Participants were randomly allocated to receive either vitamin C or placebo. Women were instructed to insert the tablets deeply into the vagina at bedtime and were supplied with 250mg vitamin C (ascorbic acid) tablets or a matching placebo (dummy).

What are the possible benefits and risks of participating?
Benefits of participating in the study was maintaining a normal vaginal acidity. No particular risks were foreseen if taking part in the study, however participants my feel some discomfort at the application site like burning and/or itching.

Where is the study run from?
From nine European sites, in Italy (Pavia, Palermo, Lavagna – Genova), Germany (Freiburg), Russia (Moscow), Ukraine (Donezk), Portugal (Porto) and The Netherlands (Dordrecht).

When is study starting and how long is it expected to run for?
The study was carried out between April 2005 and September 2008.

Who is funding the study?
Polichem SA, Lugano, Switzerland

Who is the main contact?
Dr Paola Magnani
paola.magnani@polichem.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Luigi Alio

ORCID ID

Contact details

Libero
Obstetrics and Gynaecology
Ospedale Civico e Benfratelli
Palermo
90100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PM0316

Study information

Scientific title

A randomized, comparative, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of a 250 mg Vitamin C vaginal tablet - as prophylaxis of recurrent bacterial vaginosis

Acronym

Study hypothesis

To evaluate the effect of vitamin C 250 mg vaginal tablets in comparison to placebo on bacterial vaginosis relapses occuring during the 6-cycle period of prophylaxis in women with a previous episode of bacterial vaginosisv (BV) cured with either metronidazole or clindamycin accoridng to the local therapeutic protocols.

Ethics approval

Comitato di Bioetica –Azienda di Rilievo Nazionale e di Alta Specializzazione Ospedale Civico e Benfratelli - Palermo - Italy
Comitato Etico Regione Liguria –Azienda sanitaria locale N.4 “Chiavarese” – Chiavari (GE) –Italy
Comitato di Bioetica - I.R.C.C.S. Policlinico S. Matteo - Pavia – Italy
Lokale Toetsingcommissie - Albert Schweitzer Ziekenhuis, lok. Amstelwijk – Dordrecht – The Netherlands
Ministry of Health of Ukraine -Donetsk State Medical University M. Gorky - Donetsk - Ukraine
Ethics committee at Federal Drug Quality Control - Moscow -Russia
Ethik Kommission der Albert-Ludwigs Universität – Freiburg - Germany
Comissão de Etica da Maternidade de Julio Dinis - Porto - Portugal

Study design

Multicenter randomized double-blind placebo controlled parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Prophylaxis of bacterial vaginosis

Intervention

Women, cured (confirmed by the absence of 3 out of 4 Amsel criteria) from an episode of BV by an antibiotic treatment course of either metronidazole or clindamycin, were randomly assigned to receive vitamin C 250 mg vaginal tablets or placebo as prophylaxis for 6 monthly cycles, starting within 24 hours from the determination of “BV cure”. The patients applied 1 vaginal tablet once a day for 6 consecutive days per month after menses.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time to the first BV relapse (according to Amsel criteria) in the 2 groups during the period of prophylaxis.

Secondary outcome measures

1. Vaginal signs and symptoms (Erythema, Oedema, Fissures, Odour, Itching, Burning, Dysuria, Discharge) assessed by means of a four-point scale: 1=absent; 2=mild; 3=moderate; 4=severe
2. Measurement of vaginal pH
3. Investigator’s and subject’s judgement on product acceptability and tolerability assessed by means of a four-point scale: 1= very good, 2= good, 3=fair, 4= poor, 5= very poor
4. Assessment of adverse event (AEs) occurring at any time during the study

Overall trial start date

02/04/2005

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥ 18 years and < 50 years
2. Medical history positive for recurrent BV episodes (≥ 2 by years)
3. Regular menses
4. Diagnosis of BV (≥ 3 out of 4 Amsel criteria) at enrolment
5. Cure from the current BV episode (≤ 3 out of 4 Amsel criteria) with either metronidazole or clindamycin, according to the local therapeutic protocols
6. Written informed consent
7. Co-operative and reliable women

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

142

Participant exclusion criteria

1. Subjects with known hypersensitivity to ascorbic acid or to any of the ingredients
2. Metrorrhagia, polymenorrhea, amenorrea
3. Current or previous infections due to Neisseria gonorrheae, Treponema palidum, Herpes genitalis during the last 2 weeks before enrolment
4. Current or previous infections due to Candida spp. or to Trichomonas vaginalis during the last 2 weeks before enrolment
5. Concomitant treatment with local antibiotics, such as metronidazole and clindamycin, during the study prophylaxis
6. Concomitant use of local acidifying agents, disinfectants, Lactobacillus preparations or vaginal douching during the last 2 weeks before enrolment and during the study period
7. Immunodepression, including HIV positive patients
8. Concomitant neoplastic diseases under treatment
9. Ongoing pregnancy of women willing to be pregnant during the study period
10. Participation to clinical trials with investigational drug / devices during the last 3 months before enrolment
11. History of alcohol and drug abuse
12. Subjects likely to be not compliant or uncooperative

Recruitment start date

02/04/2005

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Germany, Italy, Netherlands, Portugal, Russian Federation, Ukraine

Trial participating centre

Libero
Palermo
90100
Italy

Sponsor information

Organisation

Polichem SA (Switzerland)

Sponsor details

c/o Renata Palmieri
Lugano
6912
Switzerland

Sponsor type

Industry

Website

http://www.polichem.com/

Funders

Funder type

Industry

Funder name

Polichem SA (Swizerland)

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