Bacterial Vaginosis
Conditions
Keywords
bacterial vaginosis, vaginal infection, BV
Brief summary
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.
Interventions
DRUGGDC-229
GDC-229 is a vaginal gel.
DRUGMetronidazole Vaginal Gel 0.75%
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
DRUGPlacebo
Inactive arm of the study
Sponsors
Premier Research
Balmoral Medical company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-pregnant female aged ≥ 18 years who is in good general health 2. Diagnosis of BV 3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial 4. Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study 5. Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol
Exclusion criteria
1. History of alcohol or substance abuse 2. Experienced a clinically significant medical event within 90 days 3. Abnormal pap or high risk human papillomavirus (HPV) 4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease 5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period 6. Primary or secondary immunodeficiency 7. Evidence of any vulvovaginitis at screening other than BV 8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel 9. Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Day 21-30 | Resolution of clinical signs and symptoms |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: March 2017 to November 2017 The location of clinical sites included women's health clinics and clinical research centers
Pre-assignment details
All subjects who met the entry criteria were randomized and enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Drug GDC-229 gel applied vaginally as directed.
GDC-229: GDC-229 is a vaginal gel. | 287 |
| Reference Drug Metronidazole Vaginal Gel, 0.75% applied vaginally as directed.
Metronidazole Vaginal Gel 0.75%: Metronidazole Vaginal Gel 0.75% is an FDA-approved drug | 285 |
| Vehicle Placebo Gel GDC-229 Vehicle
Placebo: Inactive arm of the study | 292 |
| Total | 864 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Abnormal Laboratory Value | 7 | 11 | 12 |
| Overall Study | Adverse Event | 2 | 1 | 4 |
| Overall Study | Lack of Efficacy | 0 | 0 | 5 |
| Overall Study | Lost to Follow-up | 12 | 14 | 7 |
| Overall Study | Noncompliance with study drug | 2 | 3 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Pregnancy | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 6 |
Baseline characteristics
| Characteristic | Test Drug | Total | Vehicle Placebo Gel | Reference Drug |
|---|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 8.56 | 33.3 years STANDARD_DEVIATION 9.32 | 33.5 years STANDARD_DEVIATION 9.77 | 33.2 years STANDARD_DEVIATION 9.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 160 Participants | 56 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 233 Participants | 701 Participants | 235 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 10 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 161 Participants | 483 Participants | 164 Participants | 158 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 10 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 117 Participants | 351 Participants | 117 Participants | 117 Participants |
| Region of Enrollment United States | 287 Participants | 864 Participants | 292 Participants | 285 Participants |
| Sex: Female, Male Female | 287 Participants | 864 Participants | 292 Participants | 285 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 287 | 0 / 285 | 0 / 292 |
| other Total, other adverse events | 44 / 287 | 37 / 285 | 35 / 292 |
| serious Total, serious adverse events | 2 / 287 | 0 / 285 | 2 / 292 |
Outcome results
Primary
Clinical Cure
Resolution of clinical signs and symptoms
Time frame: Day 21-30
Population: Modified Intent-to-Treat (mITT) population: All randomized subjects who received study treatment and returned for at least one post-baseline visit, but excluding those who demonstrate a positive test result for other concomitant vaginal or cervical infections at baseline (e.g. C. trachomatis, N. gonorrhoeae) or who have a baseline Nugent score\<4.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Drug | Clinical Cure | 135 Participants |
| Reference Drug | Clinical Cure | 129 Participants |
| Vehicle Placebo Gel | Clinical Cure | 74 Participants |
p-value: <0.001Chi-squared, Corrected
p-value: <0.001Chi-squared, Corrected