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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02236156
Other study ID # SPL7013-018
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 3, 2014
Est. completion date October 4, 2016

Study information

Verified date June 2018
Source Starpharma Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.


Description:

Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 637
Est. completion date October 4, 2016
Est. primary completion date July 4, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)

- History of recurrent BV (at least 3 episodes in previous year including current episode)

- Using an effective method of contraception

Exclusion Criteria:

- Test positive for a sexually transmitted infection

- Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment

- Abnormal pelvic exam, including presence of other vaginal or urinary tract infections

- Pregnancy

Study Design


Intervention

Drug:
Metronidazole oral tablets 500mg
One tablet taken orally twice daily for seven consecutive days
1% SPL7013 Gel
5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
Placebo gel
5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Locations

Country Name City State
Bulgaria Sites Various Pleven
Bulgaria Sites Various Plovidiv
Bulgaria Sites Various Sofia
Bulgaria Sites Various Stara Zagora
Czechia Sites Various Brno
Czechia Sites Various Ceske Budejovice
Czechia Sites Various Olomouc
Czechia Sites Various Pisek
Czechia Sites Various Praha 2
Czechia Sites Various Vsetin
Hungary Sites Various Baja
Hungary Sites Various Balatonfured
Hungary Sites Various Budapest
Hungary Sites Various Debrecen
Hungary Sites Various Gyomro
Hungary Sites Various Komarom
Hungary Sites Various Letavertes
Hungary Sites Various Zalaegerszeg
Ukraine Sites Various Ivano-Frankivsk
Ukraine Sites Various Kyiv
Ukraine Sites Various Zaporizhzhia
United Kingdom Sites Various Birmingham
United Kingdom Sites Various Coventry
United Kingdom Sites Various Leeds
United Kingdom Sites Various London
United Kingdom Sites Various Plymouth
United States Southern Clinical Research Associates Metairie Louisiana
United States Precision Trials, LLC Phoenix Arizona
United States Medical Center for Clinical Research San Diego California
United States Lyndhurst Clinical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Starpharma Pty Ltd

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings Number of participants with a recurrence At or by the Week 16 visit
Secondary Time to recurrence of BV according to the primary efficacy endpoint definition Time (days) At or by the Week 28 visit
Secondary Presence of patient-reported BV symptoms Number of participants with symptoms At or by the Week 16 visit
Secondary Recurrence of individual Amsel criteria Individual Amsel criteria are:
i) Presence of homogenous vaginal discharge characteristic of BV
ii) Positive whiff test
iii) Clue cells representing at least 20% of total epithelial cells
iv) vaginal fluid pH greater than 4.5
At or by the Week 16 visit
Secondary Recurrence of BV as determined by presence of a Nugent score of 7-10 Number of participants with a recurrence At or by the Week 16 visit
Secondary Recurrence of BV according to the primary efficacy endpoint definition Number of participants with a recurrence At or by the Week 20, 24 and 28 visits
Secondary Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4 Number of participants with a recurrence At or by the Week 16 visit
Secondary Adverse events (AEs) Number of participants Study duration
Secondary Responses to Quality of Life (QoL) Questionnaires Screening to Week 16
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