Clinical study of SPL7013 Gel for the treatment of bacterial vaginosis

Conditions: Bacterial vaginosis
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-000752-33-DE

Lead Sponsor: Starpharma Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 240

Inclusion Criteria

1.Women who are 12 or older
2.A diagnosis of BV defined as presentation with all of the four Amsel Criteria (i.e. all four of the following symptoms: presence of white to grey homogeneous discharge; positive whiff test [amine odor] following addition of potassium hydroxide [KOH] to a vaginal fluid sample; vaginal pH greater than 4.5; and presence of clue cells [=20% of total epithelial cells]), and a Nugent score of =4 (patients may be enrolled pending Nugent score results provided a BV Blue® test is positive).
3.Willing and able to provide written informed consent.
4.Healthy as assessed by medical history and medical interview.
5.If heterosexual or bisexual and of child-bearing potential, using an effective method of contraception with an intention to use this method for the duration of study participation, including one month after cessation of study product. An effective method of contraception” is defined as: surgical sterilization; documented vasectomy of partner(s); intra-uterine device inserted at least 30 days prior to entry in to the study; lubricated condoms (that do not contain nonoxynol-9 [N-9]); or hormonal contraception (non-vaginally administered).
6.Able to understand and willing to comply with study protocol procedures and restrictions.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Allergy or history of allergy to topical vaginal products, or to SPL7013 Gel, HEC placebo gel or their components.
2.Abnormal pelvic examination at baseline that, in the investigator’s opinion, indicates the participant is unsuitable for the study, including presence of vulvovaginitis and/or cervicitis.
3.Tests positive for Chlamydia, gonorrhea or trichomoniasis infection during screening (patients may be enrolled pending STI screening results); and/or signs/symptoms of active genital HSV-1 or HSV-2 infection.
4.Participation in any other drug or device study less than 30 days prior to screening and/or prior participation in this or any other SPL7013 Gel study.
5.Any social or medical condition precluding enrolment in to the study.
6.Use of oral and/or vaginal antibiotics or antifungals within 14 days of enrolment.
7.Tests positive for urinary tract infection (by urine dipstick) (women may be treated for their UTI and re-screened once the infection has fully resolved and exclusion criterion 7 is fulfilled).
8.Reported clinically significant abnormalities on Papanicolaou (Pap) smear in previous 2 years (or in line with local guidelines) for participants over 21 years old (if not available, screening will be offered in accordance with local clinical guidance and patients may be enrolled with results pending). Clinically significant is defined as CIN2 or CIN3 changes.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of 1% SPL7013 Gel compared with placebo gel for the treatment of bacterial vaginosis (BV);Secondary Objective: To determine the safety and tolerability of 1% SPL7013 Gel;Primary end point(s): E.5.1 Primary End Point (repeat as necessary) : Clinical Cure defined as resolution of clinical findings (i.e. Amsel criteria) from the Baseline visit (Day 1). Clinical Cure requires the status of specific Amsel criteria to be as follows: (i) the original discharge, characteristic of BV and meeting the Amsel criterion for abnormal discharge at baseline, has returned to normal physiological discharge, (ii) whiff test is negative for amine odor, and (iii) a saline wet-mount shows <20% clue cells. <br>;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this endpoint: Test of Cure visit (TOC) (Day 21-30)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical cure<br>Cure, defined as a Nugent score of 0-3<br>Incidence of adverse events<br>;Timepoint(s) of evaluation of this end point: Clinical Cure: End of Treatment (EOT) visit (Day 9-12)<br><br>Cure, defined as a Nugent score of 0-3: TOC visit and EOT visit<br><br>Incidence of adverse events: At any time during study period (Baseline (Day 1) to TOC visit<br>

Related Trials