Clinical Trials Register

Summary
EudraCT Number:	2014-000694-39
Sponsor's Protocol Code Number:	SPL7013-018
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-03
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

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2014-000694-39

A.3

Full title of the trial

A phase 3, double-blind, multicentre, randomised, placebo-controlled study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) to prevent the recurrence of bacterial vaginosis

Dvojitě zaslepené, multicentrické, randomizované, placebem kontrolované klinické hodnocení fáze 3 posuzující účinnost a bezpečnost přípravku SPL7013 Gel (VivaGel®) k prevenci opakování bakteriální vaginózy

A.3.1

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

A clinical study to assess how safe and efficient is SPL7013 Gel (VivaGel®) in prevention of repeated episodes of bacterial vaginosis, compared to placebo.

A.3.2

Name or abbreviated title of the trial where available

Harmony

A.4.1

Sponsor's protocol code number

SPL7013-018

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 Building, 75 Commercial Road
B.5.3.2	Town/ city	Melbourne
B.5.3.3	Post code	3004
B.5.3.4	Country	Australia
B.5.4	Telephone number	+6138532 2712
B.5.5	Fax number	+6139510 5955
B.5.6	E-mail	clare.price@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.3.8	INN - Proposed INN	astodrimer sodium
D.3.9.1	CAS number	676271-69-5
D.3.9.2	Current sponsor code	SPL-7013
D.3.9.3	Other descriptive name	SPL7013
D.3.9.4	EV Substance Code	SUB166925
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Vaginal 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

recurrent bacterial vaginosis

E.1.1.1

Medical condition in easily understood language

repeated episodes of bacterial vaginal infection

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10004055
E.1.2	Term	Bacterial vaginosis
E.1.2	System Organ Class	10021881 - Infections and infestations

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 determine the efficacy of 1% SPL7013 Gel in reducing the risk of recurrent BV.

E.2.2

Secondary objectives of the trial

To determine the safety and tolerability of 1% SPL7013 Gel
To determine the impact of treatment with 1% SPL7013 Gel on quality of life

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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.

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 (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]).

E.5 End points

E.5.1

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)

E.5.1.1

Timepoint(s) of evaluation of this end point

At recurrence of BV or by week 16

E.5.2

Secondary end point(s)

• Time to recurrence of BV according to the primary efficacy endpoint definition
• Presence of patient-reported BV symptoms (vaginal odour and/or discharge) at or by the Week 16 visit
• Recurrence of individual Amsel criteria at or by the Week 16 visit
• 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
• Recurrence of BV according to the primary efficacy endpoint definition at or by the Week 28 visit
• 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.

E.5.2.1

Timepoint(s) of evaluation of this end point

At recurrence of BV or by week 16

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

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

Bulgaria

Czech Republic

Hungary

Romania

Thailand

Ukraine

United Kingdom

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

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)

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)

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

155

F.4.2

For a multinational trial

F.4.2.1

In the EEA

418

F.4.2.2

In the whole clinical trial

620

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)

In case of BV recurrence, the patients will be offered 1 course of state of the art treatment in the country or at the site. Patients, who successfully complete the clinical trial will return into normal clinical care.

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

2014-10-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-09-09

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