Clinical Trials Register

Summary
EudraCT Number:	2012-000752-33
Sponsor's Protocol Code Number:	SPL7013-016
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-19
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2012-000752-33

A.3

Full title of the trial

A phase 3, double-blind, multicenter, randomized, placebo-controlled study to assess the efficacy and safety of SPL7013 Gel (VivaGel®) for the treatment of bacterial vaginosis

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical study of SPL7013 Gel for the treatment of bacterial vaginosis

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

SPL7013-016

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Starpharma Pty Ltd
B.1.3.4	Country	Australia
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Starpharma Pty Ltd
B.4.2	Country	Australia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Starpharma Pty Ltd
B.5.2	Functional name of contact point	Clinical Development Manager
B.5.3	Address:
B.5.3.1	Street Address	Baker IDI, 75 Commercial Road
B.5.3.2	Town/ city	Melbourne, Victoria
B.5.3.3	Post code	3004
B.5.3.4	Country	Australia
B.5.4	Telephone number	0061385322700
B.5.5	Fax number	0061395105955
B.5.6	E-mail	info@starpharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VivaGel®
D.3.2	Product code	SPL7013
D.3.4	Pharmaceutical form	Vaginal gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Vaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	676271-69-5
D.3.9.2	Current sponsor code	SPL7013
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.8 to 1.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Gel
D.8.4	Route of administration of the placebo	Vaginal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bacterial vaginosis

E.1.1.1

Medical condition in easily understood language

Depletion of naturally occurring protective bacteria in the vagina, and overgrowth of other bacteria

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the efficacy of 1% SPL7013 Gel compared with placebo gel for the treatment of bacterial vaginosis (BV)

E.2.2

Secondary objectives of the trial

To determine the safety and tolerability of 1% SPL7013 Gel

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.

E.5 End points

E.5.1

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.

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint of evaluation of this endpoint: Test of Cure visit (TOC) (Day 21-30)

E.5.2

Secondary end point(s)

Clinical cure
Cure, defined as a Nugent score of 0-3
Incidence of adverse events

E.5.2.1

Timepoint(s) of evaluation of this end point

Clinical Cure: End of Treatment (EOT) visit (Day 9-12)

Cure, defined as a Nugent score of 0-3: TOC visit and EOT visit

Incidence of adverse events: At any time during study period (Baseline (Day 1) to TOC visit

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

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:

225

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Post-menarchal girls from 12-18 years

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

240

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Those women who have not responded to treatment, or who relapse, will be offered rescue therapy.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-05-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-10-05

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials