A clinical study to assess how safe and efficient is SPL7013 Gel (VivaGel®) in prevention of repeated episodes of bacterial vaginosis, compared to placebo.
- Conditions
- recurrent bacterial vaginosisMedDRA version: 17.0Level: PTClassification code 10004055Term: Bacterial vaginosisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-000694-39-HU
- Lead Sponsor
- Starpharma Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 620
1.Women aged 18-45 years, inclusive.
2.Have a current episode of BV diagnosed as:
-presentation with at least three of the four Amsel criteria (i.e. presence of homogeneous discharge characteristic of BV, positive whiff test, clue cells representing at least 20% of total epithelial cells, and vaginal fluid pH greater than 4.5);
-a Nugent score of =4 (patients may be enrolled pending Nugent score results provided a BV Blue® test is positive); and
-current patient reported symptoms consistent with BV or symptoms experienced within the previous three days in association with the current episode (i.e. any vaginal discharge, considered by the participant to be abnormal, and/or unpleasant vaginal odour).
3.Have a history of recurrent BV, defined as at least three documented episodes in the previous 12 months, including the current episode, as indicated by participant’s medical history and/or record of a prescription of medication to treat an episode of BV. Participants may be enrolled with documentation pending provided that verbal or written confirmation has been provided by a medical doctor or pharmacist who will supply the documentation.
4.Willing and able to provide written informed consent.
5.Other than for the presence of BV, participant is of general good health (i.e. no health issues that would hinder attendance to the clinic or study compliance, or confound study endpoints) as assessed by medical history and medical interview.
6.If heterosexual or bisexual and of child-bearing potential, participant is 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 sterilisation; documented vasectomy of partner(s); intra-uterine device inserted at least 30 days prior to entry in to the study; lubricated condoms (without nonoxynol-9 [N-9]); or hormonal contraception (non-vaginally administered) that has reached its maximum protective effect (e.g. combined oral contraceptives have commenced at least seven days prior to Screening unless commenced within five days of end of menses e.t.c.).
7.Able to understand and willing to comply with study protocol procedures and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 620
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Allergy or history of allergy to topical vaginal products, or to SPL7013 Gel, HEC placebo gel or their components.
2.Abnormal pelvic (urogenital) examination that, in the investigator’s opinion, indicates the participant is unsuitable for the study, including presence of vulvovaginitis and/or cervicitis or presence of a genital wart requiring treatment. Cases of candidiasis may be treated with an antifungal, and participant re-screened, provided that all inclusion and exclusion criteria are fulfilled at the time of re-screening.
3.Tests positive for Chlamydia, gonorrhoea or trichomoniasis infection during screening (patients may be enrolled pending STI screening results). Participants may be treated and re-screened once infection has been treated and a negative test returned, and provided that all inclusion and exclusion criteria are fulfilled at the time of re-screening.
4.Signs/symptoms of active genital HSV-1 or HSV-2 infection. Participants may be treated and re-screened once symptoms have fully resolved, provided that all inclusion and exclusion criteria are fulfilled at the time of re-screening.
5.Participation in any other drug or device study less than 30 days prior to Screening.
6.Pregnant (positive urine pregnancy test [UPT]), planning to become pregnant, or breast-feeding, or within 3 months of last pregnancy outcome.
7.Use of oral and/or vaginal antibiotics or vaginal antifungals within 14 days of Screening.
8.Tests positive for urinary tract infection (UTI) by urine dipstick. Participants may be treated for their UTI and re-screened once the infection has fully resolved and provided that all inclusion and exclusion criteria are fulfilled at the time of re-screening.
9.Reported clinically significant abnormalities on Papanicolaou (Pap) smear in previous 2 years (or in line with local guidelines) for participants over 21 years of age (if not available, a Pap smear 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 or HSIL changes.
10.Under treatment for cervical intra-epithelial neoplasia or cervical carcinoma or expected to start treatment during the course of the study.
11.In the opinion of the investigator, should not participate in the study.
12.Any social or medical condition that, in the investigator’s opinion, would preclude enrolment in to the study (i.e. any medical condition that is unstable, life threatening, likely to lead to hospitalisation, or may compromise participant’s ability to attend the clinic or undertake a pelvic exam, or any social condition or situation that may make the participant unreliable [e.g. history of drug or alcohol abuse or homelessness]).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of 1% SPL7013 Gel in reducing the risk of recurrent BV.;Secondary Objective: To determine the safety and tolerability of 1% SPL7013 Gel <br>To determine the impact of treatment with 1% SPL7013 Gel on quality of life<br>;Primary end point(s): The primary efficacy endpoint is the recurrence of BV, at or by the Week 16 visit, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (i.e., at least 3 of the 4 Amsel criteria);Timepoint(s) of evaluation of this end point: At recurrence of BV or by week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Time to recurrence of BV according to the primary efficacy endpoint definition<br>•Presence of patient-reported BV symptoms (vaginal odour and/or discharge) at or by the Week 16 visit<br>•Recurrence of individual Amsel criteria at or by the Week 16 visit<br>•Recurrence of BV as determined by the presence of a Nugent score of 7-10 at or by the Week 20, 24 and 28 visits<br>•Recurrence of BV according to the primary efficacy endpoint definition at or by the Week 28 visit<br>•Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4 at or by the Week 16 visit.<br>;Timepoint(s) of evaluation of this end point: At recurrence of BV or by week 16