Endometrial BiopsyPhase 2NCT02465320
COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
A Phase 2 study testing COL-1077 in people with Endometrial Biopsy, run by Juniper Pharmaceuticals, Inc. at 23 sites in United States.
Trial summary
The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel) will be effective as an acute-use anesthetic and can decrease the pain intensity associated with gynecologic procedures using endometrial biopsy as a representative procedure. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Endometrial Biopsy
- What is being tested?
- COL-1077
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 23 sitesUnited States
- Study dates
- May 2015to Jul 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
- For those women who are thought to be postmenopausal, postmenopausal will be defined as at least 6 months of confirmed amenorrhea with follicle stimulating hormone (FSH) levels of ≥ 40.0 mIU/mL
- Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
- Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
- Willing and able to attend all study visits and complete the pain assessments
- Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy
- Women of childbearing potential must use adequate birth control measures during the course of the study and for at least 7 days after completing study treatment.
- Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Who cannot join
- Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
- Coagulation disorders
- Experiencing daily baseline pelvic or chronic pain
- Experiencing menstruation or anticipated menstrual cycle during the study period
- Currently using an intrauterine device (IUD) or vaginal ring
- Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma
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- Women who are pregnant or lactating.
- Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics
- Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories
- Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)
- Regular use of any concomitant medications that might confound efficacy and/or safety assessments
- Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications
- Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator
- History of severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results
- Evidence of current alcohol or drug abuse.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Albany Medical College
Albany, New York, 12208
South Florida Medical Research
Aventura, Florida, 33180
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Bluebird Clinical Trials
Colorado Springs, Colorado, 80923
Physicians Research Options
Draper, Utah, 84020
Carolina Womens Research Wellness Center
Durham, North Carolina, 27713
Unified Women's Clinical Research - Greensboro
Greensboro, North Carolina, 27408
Rosemark Women Care Specialist
Idaho Falls, Idaho, 83404
Red Rocks OB/GYN
Lakewood, Colorado, 80228
Accent Clinical Trial
Las Vegas, Nevada, 89119
Lawrence OB-GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln PC
Lincoln, Nebraska, 68510
Axcess Medical Research
Loxahatchee Groves, Florida, 33470
South Florida Clinical Research Institute
Margate, Florida, 33063
New Age Medical Research Corporation
Miami, Florida, 33186
New York Center for Women's Health Research
New York, New York, 10038
Ideal Clinical Research
North Miami Beach, Florida, 33162
Futura Research
Norwalk, California, 90650
Wake Research Associates
Raleigh, North Carolina, 27612
WR Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
North Spokane Women's Health
Spokane, Washington, 99207
Hawthorne Medical Research Inc.
Winston-Salem, North Carolina, 27103
Lyndhurt Clinical Research (Unified Women's Clinical Research)
Winston-Salem, North Carolina, 27103
About this study
Official title: A Muticenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single-Dose of COL-1077 in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel) will be effective as an acute-use anesthetic and can decrease the pain intensity associated with gynecologic procedures using endometrial biopsy as a representative procedure.
Read the detailed description
COL-1077 is to be self-administered by patients prior to an outpatient transvaginal pipelle-directed endometrial biopsy with tenaculum placement in otherwise healthy women requiring biopsy.
- Conditions
- Endometrial Biopsy
- Being tested
- COL-1077, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COL-1077Drug
Also called lidocaine bioadhesive gel, 10%
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
PlaceboDrug
Also called bioadhesive gel
single dose of bioadhesive gel administered by intravaginal insertion
| Study group | Role | What they receive |
|---|---|---|
| COL-1077 | Active comparator | lidocaine bioadhesive gel, 10% Receives: Drug: COL-1077 |
| Placebo | Placebo comparator | placebo bioadhesive gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
Measured: at the time of endometrial biopsy
Secondary outcomes (5)
Pain intensity (using 11-point NPRS)
Measured: at the time of tenaculum placement, at the time of insertion of the pipelle, 1 minute following tenaculum removal, 5, 15, 30 and 60 minutes & 2, 6, 8, & 24 hours post-endometrial biopsy
Time-Weighted Average Pain Intensity (TWAPI)
Measured: time of tenaculum placement until 2 hours post-endometrial biopsy
Sum Pain Intensity Difference (SPID)
Measured: time of tenaculum placement until 2 & 8 hours post-endometrial biopsy
Rescue medication usage
For those who used rescue medication, time to first dose of rescue medication \& total number of rescue doses used will be determined
Measured: up to 24 hours post-endometrial biopsy
Proportion of responders vs. non-responders to COL-1077.
Measured: up to 24 hours post-endometrial biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juniper Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget A Martell, MA, MD, Study director, Juniper Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465320
- Sponsor's protocol ID
- COL-1077-07
- Status last verified
- Jul 2016
- First submitted
- 1 Jun 2015
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muticenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Single-Dose of COL-1077 in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT02465320
- Acronym / sponsor ID
- COL-1077-07
- Conditions
- Endometrial Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Juniper Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jun 2015 (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 COL-1077 (10% lidocaine vaginal bioadhesive gel) will be effective as an acute-use anesthetic and can decrease the pain intensity associated with gynecologic procedures using endometrial biopsy as a representative procedure.
Detailed description
COL-1077 is to be self-administered by patients prior to an outpatient transvaginal pipelle-directed endometrial biopsy with tenaculum placement in otherwise healthy women requiring biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COL-1077 | Active comparator | Drug: COL-1077lidocaine bioadhesive gel, 10% |
| Placebo | Placebo comparator | Drug: Placeboplacebo bioadhesive gel |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
- For those women who are thought to be postmenopausal, postmenopausal will be defined as at least 6 months of confirmed amenorrhea with follicle stimulating hormone (FSH) levels of ≥ 40.0 mIU/mL
- Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
- Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
- Willing and able to attend all study visits and complete the pain assessments
Key exclusion criteria (15 listed)
- Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
- Coagulation disorders
- Experiencing daily baseline pelvic or chronic pain
- Experiencing menstruation or anticipated menstrual cycle during the study period
- Currently using an intrauterine device (IUD) or vaginal ring
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 |
|---|---|---|
| COL-1077Also: lidocaine bioadhesive gel, 10%single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion | Drug | COL-1077 |
| PlaceboAlso: bioadhesive gelsingle dose of bioadhesive gel administered by intravaginal insertion | Drug | Placebo |
Primary outcome
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
Time frame: at the time of endometrial biopsy
5 secondary outcomes
Pain intensity (using 11-point NPRS)
Time frame: at the time of tenaculum placement, at the time of insertion of the pipelle, 1 minute following tenaculum removal, 5, 15, 30 and 60 minutes & 2, 6, 8, & 24 hours post-endometrial biopsy
Time-Weighted Average Pain Intensity (TWAPI)
Time frame: time of tenaculum placement until 2 hours post-endometrial biopsy
Sum Pain Intensity Difference (SPID)
Time frame: time of tenaculum placement until 2 & 8 hours post-endometrial biopsy
Rescue medication usage
Time frame: up to 24 hours post-endometrial biopsy
Proportion of responders vs. non-responders to COL-1077.
Time frame: up to 24 hours post-endometrial biopsy
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 13 Jul 2016.
- 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.
Bridget A Martell, MA, MD study director
Juniper Pharmaceuticals, Inc.
23 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 COL-1077 in people with Endometrial Biopsy, run by Juniper Pharmaceuticals, Inc. at 23 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 8 inclusion and 15 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. 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 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?
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS) (time frame: at the time of endometrial biopsy). 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 13 Jul 2016.