Candidiasis, VulvovaginalPhase 2NCT02733432
RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections
A Phase 2 study testing CD101 Vaginal Gel (3%), CD101 External gel (1%) and CD101 Vaginal Ointment (6%) in people with Candidiasis, Vulvovaginal and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 24 sites in United States.
Trial summary
The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal, Mycoses, Yeast Infection
- What is being tested?
- CD101 Vaginal Gel (3%), CD101 External gel (1%) and CD101 Vaginal Ointment (6%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 24 sitesUnited States
- Study dates
- 8 Jun 2016to 23 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- moderate to severe acute vulvovaginal candidiasis (severity score >7)
- positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
- vaginal pH <4.5 for subjects with positive potassium hydroxide wet preparation
- able to give written informed consent
Who cannot join
- receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
- known or suspected infectious causes of vulvovaginitis other than candidiasis
- history of genital herpes
- planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
- need for non-protocol systemic or vaginal antifungal therapy
- history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
Show all 12Show fewer
- pregnant females
- females who are breast feeding
- women intending to become pregnant during the study period
- recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
- subjects who use or anticipate use of intravaginal products
- have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Augusta University
Augusta, Georgia, 30912
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Olympian Clinical Research
Clearwater, Florida, 33756
Women's Medical Research
Clearwater, Florida, 33759
Aventiv Research Inc
Columbus, Ohio, 43123
Tolan Park Clinic
Detroit, Michigan, 48201
TMC Life Research Inc.
Houston, Texas, 77054
Altus Research Inc
Lake Worth, Florida, 33461
Lawrence OB GYN Clinical Research LLC
Lawrenceville, New Jersey, 08648
The Women's Clinical, P.A.
Little Rock, Arkansas, 72205
Clinical Trials Management LLC
Metairie, Louisiana, 70006
New Age Medical Research Corporation
Miami, Florida, 33186
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Tidewater Clinical Research, Inc
Norfolk, Virginia, 23502
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Precision Trials AZ LLC
Phoenix, Arizona, 85032
ProHEALTH Care Associates, LLP
Port Jefferson, New York, 11777
Alliance Women's Research Group LLC
Riverside Park, New Jersey, 08075
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604
Clinical Trials of Texas Inc
San Antonio, Texas, 78229
Women's Health Care Research Corp
San Diego, California, 92111
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105
Hawthorne Medical Research Inc
Winston-Salem, North Carolina, 27103
Unified Women's Clinical Research - Hickory
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis
The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.
Read the detailed description
This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \& Day 28 (+/-7 days) to assess therapeutic cure and safety.
- Conditions
- Candidiasis, Vulvovaginal, Mycoses, Yeast Infection, Moniliasis, Vulvovaginal, Vaginitis, Monilial
- Being tested
- CD101 Vaginal Gel (3%), CD101 External gel (1%), CD101 Vaginal Ointment (6%), CD101 External ointment (1%), Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD101 Vaginal Gel (3%)Drug
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
CD101 External gel (1%)Drug
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
CD101 Vaginal Ointment (6%)Drug
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
CD101 External ointment (1%)Drug
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
FluconazoleDrug
oral fluconazole (150mg) on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours. Receives: Drug: CD101 Vaginal Gel (3%); Drug: CD101 External gel (1%) |
| Cohort 2 | Experimental | CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours. Receives: Drug: CD101 Vaginal Ointment (6%); Drug: CD101 External ointment (1%) |
| Cohort 3 | Active comparator | Oral fluconazole (150mg) administered on day 1. Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
adverse events, clinical chemistry and hematology, pelvic exams
Measured: Day 28 - 35
Secondary outcomes (6)
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Measured: Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Measured: Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System
Change in clinical signs and subject symptoms of VVC
Measured: Day 28 - 35
Mycological Culture
Culture negative for Candida
Measured: Day 7 (+/- 2days)
Mycological Culture
Culture negative Candida
Measured: Day 14 (+/- 2days)
Mycological Culture
Culture negative Candida
Measured: Day 28 -35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start8 Jun 2016
- Primary completion23 Nov 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alena Jandourek, MD, Study director, Cidara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733432
- Sponsor's protocol ID
- CD101.TP.2.01
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2016
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT02733432
- Acronym / sponsor ID
- CD101.TP.2.01
- Conditions
- Candidiasis, Vulvovaginal, Mycoses, Yeast Infection, Moniliasis, Vulvovaginal, Vaginitis, Monilial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.
Detailed description
This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \& Day 28 (+/-7 days) to assess therapeutic cure and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CD101 Vaginal Gel (3%), Drug: CD101 External gel (1%)CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 2 | Experimental | Drug: CD101 Vaginal Ointment (6%), Drug: CD101 External ointment (1%)CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours. |
| Cohort 3 | Active comparator | Drug: FluconazoleOral fluconazole (150mg) administered on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- moderate to severe acute vulvovaginal candidiasis (severity score >7)
- positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
- vaginal pH <4.5 for subjects with positive potassium hydroxide wet preparation
- able to give written informed consent
Key exclusion criteria (12 listed)
- receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
- known or suspected infectious causes of vulvovaginitis other than candidiasis
- history of genital herpes
- planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
- need for non-protocol systemic or vaginal antifungal therapy
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 |
|---|---|---|
| CD101 Vaginal Gel (3%)CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2 | Drug | Cohort 1 |
| CD101 External gel (1%)CD101 external gel (1%) applied topically twice daily over 72 hours as needed | Drug | Cohort 1 |
| CD101 Vaginal Ointment (6%)CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1 | Drug | Cohort 2 |
| CD101 External ointment (1%)CD101 external ointment (1%) applied topically twice daily over 72 hours as needed | Drug | Cohort 2 |
| Fluconazoleoral fluconazole (150mg) on Day 1 | Drug | Cohort 3 |
Primary outcome
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Time frame: Day 28 - 35
adverse events, clinical chemistry and hematology, pelvic exams
6 secondary outcomes
Change in Vulvovaginal Scoring System
Time frame: Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System
Time frame: Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System
Time frame: Day 28 - 35
Mycological Culture
Time frame: Day 7 (+/- 2days)
Mycological Culture
Time frame: Day 14 (+/- 2days)
Mycological Culture
Time frame: Day 28 -35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Alena Jandourek, MD study director
Cidara Therapeutics
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD101 Vaginal Gel (3%), CD101 External gel (1%) and CD101 Vaginal Ointment (6%) in people with Candidiasis, Vulvovaginal and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 24 sites 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 4 inclusion and 12 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] (time frame: Day 28 - 35). 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 31 Aug 2020.