Efficacy and Safety Study of SPL7013 Gel to Prevent the R... | NCT02237950

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1% SPL7013 Gel	Experimental	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg Drug: 1% SPL7013 Gel
Placebo Gel	Placebo Comparator	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks	Drug: Metronidazole oral tablets 500mg Drug: Placebo gel

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole oral tablets 500mg	Drug	One tablet taken orally twice daily for seven consecutive days	1% SPL7013 Gel Placebo Gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)	At or by the Week 16 visit

Secondary Outcomes

Measure	Description	Time Frame
Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings	Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)	At or by the Week 16 visit
Recurrence of Patient-reported BV Symptoms

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jeremy Paull, PhD.	Starpharma Pty Ltd	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35233	United States
Montgomery Women's Health Associates

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.

Arm/Group Information

ID	Title	Description
BG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
BG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000130 OG001158

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.015														Superiority

Secondary

Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings

Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

Posted

Median

95% Confidence Interval

days

At or by the Week 16 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts

Secondary

Recurrence of Patient-reported BV Symptoms

Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)

Modified Intent-to-Treat, excluding patients with missing values.

Posted

Count of Participants

Participants

At or by the Week 16 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts
Participants

Secondary

Recurrence of Individual Amsel Criteria

Number of participants with positive individual Amsel criterion

- Clue cells representing at least 20% of total epithelial cells

Modified Intent-to-Treat, excluding patients with missing values.

Posted

Count of Participants

Participants

At or by the Week 16 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts
Participants

Secondary

Recurrence of BV as Determined by Presence of a Nugent Score of 7-10

Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.

Modified Intent-to-Treat, excluding patients with missing values.

Posted

Count of Participants

Participants

At or by the Week 16 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts
Participants

Secondary

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 of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)

Posted

Count of Participants

Participants

At or by the Week 24 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts

Secondary

Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.

Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.

Modified Intent-to-Treat, excluding patients with missing values.

Posted

Count of Participants

Participants

At or by the Week 16 visit

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts

Secondary

Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score

Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.

Analysis population includes only those participants who completed the survey, which was optional.

Posted

Mean

95% Confidence Interval

change in score on a scale

Baseline to Week 16

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Secondary

Adverse Events (AEs)

Number of participants with genitourinary AEs considered potentially related to study treatment

Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.

Posted

Count of Participants

Participants

From Baseline to end of Week 28

ID	Title	Description
OG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.
OG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1% SPL7013 Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks 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.			4	294	92	294
EG001	Placebo Gel	Inserted in to the vagina on alternate days (i.e. every other day) for 16 weeks Metronidazole oral tablets 500mg: One tablet taken orally twice daily for seven consecutive days Placebo gel: 5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks			3	291	80	291

Serious Adverse Events

Term	Organ System	Statistical Information
Tachycardia	Cardiac disorders	EG0001 events1 affected294 at risk EG0010 events0 affected291 at risk
Bartholin's abscess	Infections and infestations	EG0000 events0 affected294 at risk EG0011 events1 affected291 at risk
Klebsiella bacteremia	Infections and infestations	EG0000 events0 affected294 at risk EG0011 events1 affected291 at risk
Hemiplegic migraine	Nervous system disorders	EG0000 events0 affected294 at risk EG0011 events1 affected291 at risk
Blighted ovum	Pregnancy, puerperium and perinatal conditions	EG0001 events1 affected294 at risk EG0011 events1 affected291 at risk
Suicidal ideation	Psychiatric disorders	EG0001 events1 affected294 at risk EG0010 events0 affected291 at risk
Menorrhagia	Reproductive system and breast disorders	EG0001 events1 affected294 at risk EG0010 events0 affected291 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Nasopharyngitis	Infections and infestations	EG0009 affected294 at risk EG00115 affected291 at risk
UTI	Infections and infestations	EG00028 affected294 at risk EG00110 affected291 at risk
Vulvovaginal candidiasis	Infections and infestations	EG00047 affected294 at risk EG00135 affected291 at risk
Vulvovaginal mycotic infection	Infections and infestations	EG00014 affected294 at risk EG00116 affected291 at risk
Headache	Nervous system disorders	EG00017 affected294 at risk EG00120 affected291 at risk

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds