COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy

July 12, 2016 updated by: Juniper Pharmaceuticals, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Norwalk, California, United States, 90650
        • Futura Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80923
        • Bluebird Clinical Trials
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OB/Gyn
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Loxahatchee, Florida, United States, 33470
        • Axcess Medical Research
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corporation
      • North Miami Beach, Florida, United States, 33162
        • Ideal Clinical Research
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • WR Mount Vernon Clinical Research, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialist
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln PC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Accent Clinical Trial
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence Ob-Gyn Clinical Research, LLC
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • New York, New York, United States, 10038
        • New York Center for Women's Health Research
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Womens Research Wellness Center
      • Greensboro, North Carolina, United States, 27408
        • Unified Women's Clinical Research - Greensboro
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurt Clinical Research (Unified Women's Clinical Research)
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians Research Options
    • Washington
      • Spokane, Washington, United States, 99207
        • North Spokane Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
  2. 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
  3. Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
  4. Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
  5. Willing and able to attend all study visits and complete the pain assessments
  6. Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy
  7. 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.
  8. Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

  1. Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
  2. Coagulation disorders
  3. Experiencing daily baseline pelvic or chronic pain
  4. Experiencing menstruation or anticipated menstrual cycle during the study period
  5. Currently using an intrauterine device (IUD) or vaginal ring
  6. Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma
  7. Women who are pregnant or lactating.
  8. Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics
  9. Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories
  10. Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)
  11. Regular use of any concomitant medications that might confound efficacy and/or safety assessments
  12. Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications
  13. Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator
  14. 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
  15. Evidence of current alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: COL-1077
lidocaine bioadhesive gel, 10%
Drug: COL-1077
single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
Other Names:
  • lidocaine bioadhesive gel, 10%
Placebo Comparator: Placebo
placebo bioadhesive gel
Drug: Placebo
single dose of bioadhesive gel administered by intravaginal insertion
Other Names:
  • bioadhesive gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain Intensity recorded on the 11-point Numerical Pain Rating Scale (NPRS)
Time Frame: at the time of endometrial biopsy
at the time of endometrial biopsy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
time of tenaculum placement until 2 & 8 hours post-endometrial biopsy
Rescue medication usage
Time Frame: up to 24 hours post-endometrial biopsy
For those who used rescue medication, time to first dose of rescue medication & total number of rescue doses used will be determined
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
up to 24 hours post-endometrial biopsy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient subjective assessment of study drug at the end of the study
Time Frame: up to 48 hours post-endometrial biopsy
Patients will be asked to rate the study drug they received for pain by answering the following question. "How would you rate the study drug you received for pain?" Responses are to be recorded as poor (1), fair (2), good (3), or excellent (4)
up to 48 hours post-endometrial biopsy
Maximum plasma concentration (Cmax)
Time Frame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Area under the plasma concentration time curve (AUC) from time 0 to time of last quantifiable concentration (AUC0-last)
Time Frame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Time to maximum concentration ( tmax)
Time Frame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Apparent clearance (CL/F)
Time Frame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Terminal elimination half-life (t1/2)
Time Frame: 1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
1 hour prior to biopsy (baseline), 30 and 60 minutes, 2, 6, 8 and 24 hours post-endometrial biopsy
Incidence of adverse events and serious adverse events as a measure of Safety and tolerability of COL-1077
Time Frame: up to 7 calendar days post-study completion
Incidence of adverse events and serious adverse events
up to 7 calendar days post-study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Juniper Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bridget A Martell, MA, MD, Juniper Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COL-1077-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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