Bacterial VaginosisPhase 3NCT03091777
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
A Phase 3 study testing GDC-229 and Metronidazole Vaginal Gel 0.75% in people with Bacterial Vaginosis, run by Balmoral Medical company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- GDC-229 and Metronidazole Vaginal Gel 0.75%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 871 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 27 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant female aged ≥ 18 years who is in good general health
- Diagnosis of BV
- 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
- 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
- Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol
Who cannot join
- History of alcohol or substance abuse
- Experienced a clinically significant medical event within 90 days
- Abnormal pap or high risk human papillomavirus (HPV)
- 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
- Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
- Primary or secondary immunodeficiency
Show all 9Show fewer
- Evidence of any vulvovaginitis at screening other than BV
- 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
- Participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis
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.
- Conditions
- Bacterial Vaginosis
- Being tested
- GDC-229, Metronidazole Vaginal Gel 0.75%, Placebo
- Keywords
- bacterial vaginosis, vaginal infection, BV
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-229Drug
GDC-229 is a vaginal gel.
Metronidazole Vaginal Gel 0.75%Drug
Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
PlaceboDrug
Inactive arm of the study
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | GDC-229 gel applied vaginally as directed. Receives: Drug: GDC-229 |
| Reference Drug | Active comparator | Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. Receives: Drug: Metronidazole Vaginal Gel 0.75% |
| Vehicle Placebo Gel | Placebo comparator | GDC-229 Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
Resolution of clinical signs and symptoms
Measured: Day 21-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start10 Mar 2017
- Primary completion15 Nov 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balmoral Medical company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091777
- Sponsor's protocol ID
- GDC-229-002
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2017
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03091777
- Acronym / sponsor ID
- GDC-229-002
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, vaginal infection, BV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Balmoral Medical companyIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 14 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: GDC-229GDC-229 gel applied vaginally as directed. |
| Reference Drug | Active comparator | Drug: Metronidazole Vaginal Gel 0.75%Metronidazole Vaginal Gel, 0.75% applied vaginally as directed. |
| Vehicle Placebo Gel | Placebo comparator | Drug: PlaceboGDC-229 Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-pregnant female aged ≥ 18 years who is in good general health
- Diagnosis of BV
- 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
- 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
- Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol
Key exclusion criteria (9 listed)
- History of alcohol or substance abuse
- Experienced a clinically significant medical event within 90 days
- Abnormal pap or high risk human papillomavirus (HPV)
- 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
- Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-229GDC-229 is a vaginal gel. | Drug | Test Drug |
| Metronidazole Vaginal Gel 0.75%Metronidazole Vaginal Gel 0.75% is an FDA-approved drug | Drug | Reference Drug |
| PlaceboInactive arm of the study | Drug | Vehicle Placebo Gel |
Primary outcome
Clinical Cure
Time frame: Day 21-30
Resolution of clinical signs and symptoms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GDC-229 and Metronidazole Vaginal Gel 0.75% in people with Bacterial Vaginosis, run by Balmoral Medical company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: Day 21-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.