Bacterial Vaginosis
Conditions
Keywords
CTV-05, LACTIN-V, Lactobacillus, MetroGel®, Vaginitis
Brief summary
This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10\^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10\^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.
Detailed description
This is a Phase II-b multicenter randomized double-blind placebo-controlled trial to assess the efficacy of repeated doses of LACTIN-V compared to placebo in preventing BV recurrence in women diagnosed with BV. The study will also assess the safety of LACTIN-V by comparing the incidence of AEs between women randomized to LACTIN-V or placebo. The study plans to enroll 228 non-pregnant, pre-menopausal women age 18 to 45 years. Women will be randomized 2:1 to receive LACTIN-V or placebo. Potentially eligible women will start a standard 5-day course of MetroGel. Women will return to the study clinic within 2 days after completing the 5-day course of MetroGel to re-evaluate eligibility criteria and review the BV test results from the screening visit. Women with Amsel criteria \> /=3 and Nugent score 4-10 will be instructed to administer the LACTIN-V or placebo at home for 5 consecutive days and then twice weekly for 10 weeks. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x109 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo. Secondary objectives are: 1) To investigate the colonization of LACTIN-V (presence of L. crispatus CTV-05 in the vaginal specimen) and fluctuations over 12 weeks, in relation to menses and sexual intercourse 2) To evaluate user acceptability and tolerability of LACTIN-V over 12 weeks, including perceptions around method of delivery and dosing. 3) To measure long-term colonization of LACTIN-V at 24 weeks (12 weeks after last dosing) 4) To estimate the long-term efficacy of repeated doses of LACTIN-V (2 x 109 cfu/dose) as compared to placebo in preventing BV recurrence at 24 weeks (12 weeks after last dosing)
Interventions
BIOLOGICALLactobacillus crispatus CTV-05
LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Subjects receive 2x10\^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.
DRUGMetronidazole
Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
OTHERPlacebo
Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1\. Capable of reading and writing English and voluntarily provide written informed consent to participate in the study and comply with all study procedures 2. Untreated BV (asymptomatic or symptomatic) as diagnosed during the screening visit defined by \>/=3 Amsel criteria. Note: Amsel criteria include the following: --Homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; --Vaginal pH \>4.5; --Positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide (KOH) is added to a sample of vaginal discharge; --Presence of clue cells (\>20% on microscopy). 3. Untreated BV(asymptomatic or symptomatic) as confirmed in the laboratory using the Nugent scoring system (Nugent Score \>/= 4) 4. Otherwise healthy pre-menopausal women 18-45 years of age on the day of screening 5. Regular predictable menstrual cycles or amenorrheic for at least 3 months due to use of a long-acting progestin or continuous use of oral contraceptives 6. Willing to be asked questions about personal medical health and sexual history. 7. Willing to apply study agent vaginally and comply with study examinations. 8. Agree to abstain from sexual intercourse during the first 5 consecutive days of study product administration, 12 hours prior to study visits and for 12 hours after each study product application 9. Agree to abstain from the use of any other intravaginal product throughout the trial period from the time of screening through Visit 7 (Week 24, Day 168) Note: Intravaginal products include contraceptive creams such as Gynol II, gels, foams, sponges, lubricants not approved by the study investigators, and douches. Limit use of tampons during menstruation to unscented products. 10. Must be of non-childbearing potential or if of childbearing potential, must agree to use a reliable method of birth control for the duration of the study Note: Reliable methods of birth control include tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD, condoms or abstinence.
Exclusion criteria
1\. Urogenital infection at screening Note: Urogenital infection includes urinary tract infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, Treponema (T.) pallidum, or vulvo-vaginal candidiasis. 2. Diagnosis of two or more outbreaks of N. gonorrhoeae, C. trachomatis, T. pallidum, T. vaginalis, or herpes simplex virus (herpes genitalis) within 6 months prior to screening 3. Positive for syphilis or HIV at screening 4. Current pregnancy or within 2 months of last pregnancy and/or currently breastfeeding\*\*. Criteria will be assessed at screening and enrollment. 5. Vaginal or systemic antibiotic or antifungal therapy (other than MetroGel given as part of study procedures) within 21 days of screening or within 30 days of enrollment\*\* 6. Use of disulfiram within past 2 weeks or other contraindication to use of MetroGel\*\* 7. Any condition requiring regular periodic use of systemic antibiotics during participation in the trial 8. Active genital herpes lesion\*\* (if not resolved by enrollment)\*\* 9. Investigational drug use other than LACTIN-V within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit\*\* 10. Other planned participation in an investigational drug study while participating in this study\*\* 11. Menopause defined as more than 12 consecutive months of amenorrhea without another known cause including pregnancy 12. IUD insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser treatment within the last 2 months prior to screening 13. Use of vaginal ring (eg, NuvaRing) within 3 days of screening or during the course of the study\*\* 14. Failure to complete 5 days of MetroGel with the last dose taken no later than 48 hours prior to randomization\*\*\* 15. Use of new long-acting hormonal treatments. Participant may be enrolled if stable (\>3 months) on existing therapy as determined by the principal investigator\*\* 16. Known allergy to any component of LACTIN-V/placebo or MetroGel or to nitroimidazole derivatives or latex (condoms) 17. Any social, medical, or psychiatric condition, including history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study \*\* Note: Criteria will be assessed at screening and enrollment. \*\*\*Note: Criteria will be assessed at enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm. | Day 1 to Day 168 | Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE. |
| The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | Day 1 to Day 84 | A positive BV diagnosis was defined by meeting at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Amsel score ranges from 0-4, where higher scores mean a worse outcome. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2, and adding all component scores. The Nugent score ranges from 0-10, where higher scores mean a worse outcome. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining. | Day 1 to Day 84 | A subject was considered compliant with the assigned study product if she took 4 of the first 5 daily doses and at least 75% of the scheduled doses overall prior to the first diagnosis of BV or through Week 12, whichever occurred first. Compliance was assessed by subject report via the memory aid and, separately, applicator staining of the returned kit. Compliance was assessed on a weekly basis and the time (week) at which the subject became non-compliant was determined by blinded PI review. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by Likert-scale responses of strongly agree, agree, neutral, disagree and strongly disagree. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including the question, If a non-antibiotic, clinically proven lactobacillus product were available for treatment and prevention of BV, what are the chances that you would use it? |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including My current partner's reaction to the product was... with the options as listed below. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including if their current partner's reaction to the product influenced their use of the product. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects. For those participants who answered Yes to experiencing side effects, a follow-up question asked would these side effects make you less likely to use the product again? |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on use of the product on a 0-10 scale, with 0 being not at all and 10 being extremely so. |
| Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Day 84 | Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on a 0-10 scale, with 0 being not at all and 10 being extremely. |
| The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall. | Day 1 to Day 84 | Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL |
| The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Day 1 | Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL |
| The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Day 28 | Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL |
| The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall. | Day 1 to Day 168 | Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL |
| The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | Day 1 to Day 168 | A positive BV diagnosis was defined by at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode. |
| The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events. | Day 1 to Day 84 | Tolerability of LACTIN-V and the applicator was measured by the proportion of participants who discontinued the study product prior to completing the dose schedule due to an adverse event. |
Countries
United States
Participant flow
Recruitment details
Participants were non-pregnant females with untreated bacterial vaginosis recruited from the clinics conducting the study and from other clinical providers coordinating referrals of eligible women to the study centers. Participants were enrolled between 03JUN2016 and 27AUG2018.
Participants by arm
| Arm | Count |
|---|---|
| LACTIN-V 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then LACTIN-V 2x10\^9 cfu/dose applied vaginally for 5 days then twice weekly for 10 weeks. | 152 |
| Placebo 5-day course of metronidazole gel 7.5 mg/gm daily applied vaginally, then placebo applied vaginally for 5 days then twice weekly for 10 weeks. | 76 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 23 | 11 |
| Overall Study | Not Eligible at Enrollment | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | LACTIN-V | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants | 76 Participants | 228 Participants |
| Age, Continuous | 30.7 years STANDARD_DEVIATION 6.8 | 31.4 years STANDARD_DEVIATION 7.1 | 30.9 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 15 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 61 Participants | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants | 31 Participants | 95 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 8 Participants | 22 Participants |
| Race (NIH/OMB) White | 55 Participants | 26 Participants | 81 Participants |
| Region of Enrollment United States | 152 participants | 76 participants | 228 participants |
| Sex: Female, Male Female | 152 Participants | 76 Participants | 228 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 76 |
| other Total, other adverse events | 131 / 151 | 60 / 76 |
| serious Total, serious adverse events | 1 / 151 | 0 / 76 |
Outcome results
Primary
The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm.
Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE.
Time frame: Day 1 to Day 168
Population: The safety population included all participants receiving study product. One participant randomized to LACTIN-V was not treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LACTIN-V | The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm. | 0.11 proportion of participants |
| Placebo | The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm. | 0.07 proportion of participants |
p-value: 0.46795% CI: [-0.1, 0.18]Fisher Exact
Primary
The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.
A positive BV diagnosis was defined by meeting at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Amsel score ranges from 0-4, where higher scores mean a worse outcome. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2, and adding all component scores. The Nugent score ranges from 0-10, where higher scores mean a worse outcome. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.
Time frame: Day 1 to Day 84
Population: The analysis population was the intent-to-treat population (all randomized participants). Missing BV recurrence data was imputed using Last Observation Carried Forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LACTIN-V | The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | 0.30 proportion of participants |
| Placebo | The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | 0.45 proportion of participants |
p-value: 0.03195% CI: [0.3, 0.95]Chi-squared
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by Likert-scale responses of strongly agree, agree, neutral, disagree and strongly disagree.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Agree | 29 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Strongly agree | 55 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Neutral | 45 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Strongly agree | 63 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Disagree | 15 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Strongly agree | 10 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Agree | 55 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Agree | 56 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Disagree | 34 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Neutral | 8 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Disagree | 3 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Disagree | 1 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Neutral | 11 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Neutral | 17 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Disagree | 4 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Strongly disagree | 0 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Agree | 58 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Strongly agree | 46 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Strongly disagree | 1 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Agree | 45 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Strongly disagree | 4 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Disagree | 1 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Neutral | 25 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Strongly disagree | 9 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Neutral | 12 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Agree | 22 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Disagree | 10 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Neutral | 34 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Strongly disagree | 30 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Strongly agree | 72 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Strongly agree | 32 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Agree | 39 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Strongly disagree | 1 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Strongly disagree | 4 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Strongly agree | 59 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Strongly disagree | 1 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Strongly agree | 22 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Agree | 30 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Neutral | 7 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Strongly disagree | 0 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Strongly agree | 23 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Agree | 32 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Neutral | 5 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Disagree | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with comfort of vaginal applicator | Strongly disagree | 1 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Strongly agree | 31 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Agree | 28 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Neutral | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Disagree | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Satisfied with ease of use of vaginal applicator | Strongly disagree | 0 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Agree | 18 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Neutral | 21 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Strongly agree | 12 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Agree | 15 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Neutral | 22 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Strongly agree | 6 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Neutral | 23 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Disagree | 13 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Strongly disagree | 11 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Agree | 24 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Neutral | 7 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I was satisfied overall with vaginal applicator | Disagree | 4 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Strongly agree | 18 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Disagree | 5 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Vaginal health improved with study participation | Strongly disagree | 1 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Disagree | 8 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important I use product without partner knowing | Strongly disagree | 6 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | Important for me that partner approved of product | Agree | 10 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Strongly agree | 28 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale | I would use the product again | Disagree | 3 Participants |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on a 0-10 scale, with 0 being not at all and 10 being extremely.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Effectiveness | 7.53 units on a scale | Standard Deviation 2.81 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Comfort | 8.16 units on a scale | Standard Deviation 2.22 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Ease of use | 8.99 units on a scale | Standard Deviation 1.57 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Vaginal health | 7.37 units on a scale | Standard Deviation 2.83 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Other Finding | 8.21 units on a scale | Standard Deviation 2.58 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Other Finding | 9.27 units on a scale | Standard Deviation 0.64 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Vaginal health | 7.01 units on a scale | Standard Deviation 2.88 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Comfort | 8.07 units on a scale | Standard Deviation 2.1 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Effectiveness | 6.72 units on a scale | Standard Deviation 2.97 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product | Ease of use | 8.75 units on a scale | Standard Deviation 1.75 |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on use of the product on a 0-10 scale, with 0 being not at all and 10 being extremely so.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Discomfort | 1.53 units on a scale | Standard Deviation 2.43 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Disapproval | 0.98 units on a scale | Standard Deviation 2.07 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | High frequency | 2.97 units on a scale | Standard Deviation 3.2 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Vaginal Dryness | 1.71 units on a scale | Standard Deviation 2.66 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Other issue | 7.08 units on a scale | Standard Deviation 1.69 |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Messiness | 2.10 units on a scale | Standard Deviation 2.82 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Other issue | 7.62 units on a scale | Standard Deviation 1.68 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Vaginal Dryness | 1.37 units on a scale | Standard Deviation 2.43 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Discomfort | 1.01 units on a scale | Standard Deviation 1.8 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Messiness | 1.68 units on a scale | Standard Deviation 2.65 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | Disapproval | 0.79 units on a scale | Standard Deviation 1.84 |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use | High frequency | 2.63 units on a scale | Standard Deviation 3.09 |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including if their current partner's reaction to the product influenced their use of the product.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire and had a current partner.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Unknown | 15 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | No | 73 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Yes, and was less likely to use it | 2 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Yes, and was more likely to use it | 19 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Unknown | 8 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Yes, and was less likely to use it | 0 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | Yes, and was more likely to use it | 9 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence | No | 36 Participants |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including My current partner's reaction to the product was... with the options as listed below.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Currently does not have a partner | 21 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Negative | 9 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Partner was unaware of product use | 20 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Unknown | 10 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Positive | 39 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Neutral | 31 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Partner was unaware of product use | 9 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Currently does not have a partner | 10 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Neutral | 16 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Positive | 23 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Negative | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product | Unknown | 3 Participants |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects. For those participants who answered Yes to experiencing side effects, a follow-up question asked would these side effects make you less likely to use the product again?
Time frame: Day 84
Population: The analysis population is limited to those participants who answered Yes to the question Did you experience any side effects using the product?
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Agree | 6 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Disagree | 20 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Neutral | 7 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Strongly disagree | 14 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Strongly agree | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Strongly disagree | 4 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Strongly agree | 1 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Agree | 3 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Neutral | 7 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use | Disagree | 4 Participants |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects.
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects | Yes | 49 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects | No | 81 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects | No | 44 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects | Yes | 19 Participants |
Secondary
Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use
Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including the question, If a non-antibiotic, clinically proven lactobacillus product were available for treatment and prevention of BV, what are the chances that you would use it?
Time frame: Day 84
Population: The analysis population includes all treated participants who completed the questionnaire.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Certain; almost certain | 83 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Very probable | 25 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Good possibility | 14 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | No chance; almost no chance | 0 Participants |
| LACTIN-V | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Slight possibility | 8 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Good possibility | 7 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Certain; almost certain | 37 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Slight possibility | 2 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | Very probable | 16 Participants |
| Placebo | Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use | No chance; almost no chance | 1 Participants |
Secondary
The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events.
Tolerability of LACTIN-V and the applicator was measured by the proportion of participants who discontinued the study product prior to completing the dose schedule due to an adverse event.
Time frame: Day 1 to Day 84
Population: The analysis population included all treated participants. One participant randomized to LACTIN-V was not treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LACTIN-V | The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events. | 1 Participants |
| Placebo | The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events. | 0 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 56
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 28 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 78 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 0 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 1 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 1
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 0 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 4 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 0 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 0 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 28
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 37 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 76 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 1 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 3 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 84
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 38 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 64 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | Condom-less sex acts since last visit | 0 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse. | No condom-less sex acts since last visit | 2 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 56
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 76 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 30 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 1 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 0 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 28
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 93 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 20 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 3 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 1 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 84
Population: The analysis population includes participants with results at the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 74 Participants |
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 28 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | Menses since last visit | 2 Participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses. | No menses since last visit | 0 Participants |
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 1 to Day 84
Population: The analysis population is intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall. | 0.85 percentage of participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall. | 0.07 percentage of participants |
p-value: <0.00195% CI: [29.02, 218.57]Chi-squared
Secondary
The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall.
Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL
Time frame: Day 1 to Day 168
Population: The analysis population was the intent-to-treat population (all randomized participants).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LACTIN-V | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall. | 0.86 percentage of participants |
| Placebo | The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall. | 0.08 percentage of participants |
p-value: <0.00195% CI: [28.07, 188.66]Chi-squared
Secondary
The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining.
A subject was considered compliant with the assigned study product if she took 4 of the first 5 daily doses and at least 75% of the scheduled doses overall prior to the first diagnosis of BV or through Week 12, whichever occurred first. Compliance was assessed by subject report via the memory aid and, separately, applicator staining of the returned kit. Compliance was assessed on a weekly basis and the time (week) at which the subject became non-compliant was determined by blinded PI review.
Time frame: Day 1 to Day 84
Population: The analysis population was the intent-to-treat population (all randomized participants).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LACTIN-V | The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining. | Self-report | 0.80 proportion of participants |
| LACTIN-V | The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining. | Staining | 0.77 proportion of participants |
| Placebo | The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining. | Self-report | 0.78 proportion of participants |
| Placebo | The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining. | Staining | 0.72 proportion of participants |
Comparison: Analysis is for self-reported compliancep-value: 0.64395% CI: [-0.08, 0.15]Chi-squared
Comparison: Analysis is for compliance assessed by staining.p-value: 0.44695% CI: [-0.07, 0.17]Chi-squared
Secondary
The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.
A positive BV diagnosis was defined by at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH \>4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (\>20%) on microscopy. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.
Time frame: Day 1 to Day 168
Population: The analysis population was the intent-to-treat population (all randomized participants).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LACTIN-V | The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | 0.39 percentage of participants |
| Placebo | The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm. | 0.54 percentage of participants |
p-value: 0.0395% CI: [0.31, 0.94]Chi-squared