DysmenorrheaPhase 2Lidocaine 04NCT00651313
Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)
A Phase 2 study testing Lidocaine in people with Dysmenorrhea, run by Juniper Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2007to Aug 2008
- Phase
- Phase 2
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experiences primary dysmenorrhea requiring pain medication for moderate-to-severe pain (as measured by a 4-point categorical rating scale) by the subject's own report for at least four of the previous six menstrual cycles.
- Has a history of primary dysmenorrhea with onset within 4 years of menarche.
- Has regular menstrual cycles (i.e. onset of menses predictable within 1 - 2 days each month) for the 3 month period preceding enrollment. If a subject has had regular cycles for the past 12 months but had a single cycle that was not regular within the 3 month period preceding enrollment, the subject may be enrolled at investigator discretion after consultation with sponsor.
- Taking the same strength and type of hormonal contraception on a monthly cycle for at least the previous 6 months prior to screening and plans to remain on this hormonal contraception for the duration of participation in the study or is on an acceptable method of birth control including surgical sterilization (i.e. bilateral tubal ligation, partner vasectomy), double-barrier methods, and total abstinence (at the discretion of the investigator in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance).
- Is a tampon user and/or must be willing to use tampons throughout the study dosing period.
- Age 18 to 40 years (inclusive).
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- Has a Body Mass Index (BMI) ≤ 35 kg/m2.
- Able to understand and willing to complete the efficacy evaluations.
- Able to speak and understand English, and must give written informed consent for the study.
Who cannot join
- Unable, in the opinion of the Investigator, to comply fully with any of the study requirements.
- Experiencing pelvic pain other than that thought to be associated with primary dysmenorrhea, such as chronic pelvic pain occurring at times other than exclusively during menses and/or dyspareunia.
- Experiencing dysmenorrhea symptoms that are effects of or thought to be effects of (at least in part) secondary causes of dysmenorrhea, such as uterine fibroids, endometriosis, and/or currently symptomatic ovarian cysts.
- Experienced dysmenorrhea that did not require, in the opinion of the subject, the use of analgesic medication during four of the previous six menstrual episodes.
- Has dysmenorrhea refractory to treatment with commonly used analgesic medications for the treatment of menstrual pain (e.g., ibuprofen or naproxen sodium).
- Use of any Class I antiarrhythmic drug.
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- Currently using contraceptive injection, implant, or extended cycle OC (hormonal contraceptive cycles consisting of 28 days or more of active hormones).
- Pregnant or breastfeeding.
- Participated in a clinical trial in the 30 days from the time of last dosing in the prior study to the time of providing consent for this study.
- Previously randomized into this study.
- A history of allergic hypersensitivity or significant intolerance (including angioedema, urticaria, bronchospasm, and rhinitis) related to treatment with any medications used in this study.
- A history of past or ongoing clinically significant disease, illness, or disorder that, in the opinion of the Investigator, makes the subject unsuitable for study participation including active vaginal, vulvar, and cervical lesions.
- Laboratory abnormalities that, in the opinion of the Investigator, could contraindicate study participation such as liver function tests > 1.5 times the upper limit of normal (At the Investigator's discretion, laboratory tests may be repeated once for verification.)
- A history of, within the past 4 years, or ongoing significant psychiatric illness that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
- A history of chronic analgesic or tranquilizer use or drug abuse including alcohol within the 6 months before providing consent for this study.
- Regular use of any concomitant medications that might confound efficacy and/or safety assessments, in the opinion of the Investigator, including, but not limited to, the following: psychotropic drugs, antidepressants, sedative-hypnotics, sedating antihistamines, or tranquilizers for 24 hours or five half-lives prior to providing informed consent until 24 hours after the final treatment cycle. Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and St. John's Wort are permitted for indications other than pain if the subject has been on a stable dose for at least 2 weeks before providing consent for this study and agrees to remain on a stable dose throughout the course of the study.
- Unwilling to use only those medications that are allowed in the study for the treatment of their dysmenorrhea, i.e., study drug and rescue medication.
- Any ongoing vaginal infection requiring intravaginal treatment.
- A history of toxic shock syndrome (TSS).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SCIREX Research Center
Austin, Texas, 78705
SCIREX Research Center
Memphis, Tennessee, 38120
Jean Brown Research
Salt Lake City, Utah, 84124
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II, Double-Blind, Crossover Study to Assess the Efficacy and Safety of 10% (150mg) Lidocaine Vaginal Gel Administered to Women With Recurrent Dysmenorrhea
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
Read the detailed description
The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.
The secondary objectives of this study are the following:
- to assess the safety of 10% (150 mg) lidocaine gel compared with placebo
- to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.
- Conditions
- Dysmenorrhea
- Being tested
- Lidocaine, Placebo
- Keywords
- Dysmenorrhea, Periods, Menstrual, Primary dysmenorrhea in women with recurrent dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
PlaceboDrug
Placebo vaginal gel administered once daily for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Lidocaine 10% (150mg) vaginal gel Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Placebo vaginal gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.
Measured: Two 4-day dosing regimens for two consecutive monthy menstrual cycles
Treatment-emgergent Adverse Events
Measured: approximately two months, based on onset of menses
Secondary outcomes (1)
Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing
Measured: 7 hours following fourth dose in 2 consecutive menstrual cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionAug 2008
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 DysmenorrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juniper Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George W Creasy, MD, Study director, Juniper Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651313
- Sponsor's protocol ID
- COL-1077-04
- Acronym
- Lidocaine 04
- Status last verified
- Feb 2012
- First submitted
- 28 Mar 2008
- Last updated
- 17 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Crossover Study to Assess the Efficacy and Safety of 10% (150mg) Lidocaine Vaginal Gel Administered to Women With Recurrent Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00651313
- Acronym / sponsor ID
- Lidocaine 04 / COL-1077-04
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, Periods, Menstrual, Primary dysmenorrhea in women with recurrent dysmenorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Juniper Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 6 Jul 2011
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 whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
Detailed description
The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.
The secondary objectives of this study are the following:
- to assess the safety of 10% (150 mg) lidocaine gel compared with placebo
- to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: LidocaineLidocaine 10% (150mg) vaginal gel |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo vaginal gel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Experiences primary dysmenorrhea requiring pain medication for moderate-to-severe pain (as measured by a 4-point categorical rating scale) by the subject's own report for at least four of the previous six menstrual cycles.
- Has a history of primary dysmenorrhea with onset within 4 years of menarche.
- Has regular menstrual cycles (i.e. onset of menses predictable within 1 - 2 days each month) for the 3 month period preceding enrollment. If a subject has had regular cycles for the past 12 months but had a single cycle that was not regular within the 3 month period preceding enrollment, the subject may be enrolled at investigator discretion after consultation with sponsor.
- Taking the same strength and type of hormonal contraception on a monthly cycle for at least the previous 6 months prior to screening and plans to remain on this hormonal contraception for the duration of participation in the study or is on an acceptable method of birth control including surgical sterilization (i.e. bilateral tubal ligation, partner vasectomy), double-barrier methods, and total abstinence (at the discretion of the investigator in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance).
- Is a tampon user and/or must be willing to use tampons throughout the study dosing period.
Key exclusion criteria (19 listed)
- Unable, in the opinion of the Investigator, to comply fully with any of the study requirements.
- Experiencing pelvic pain other than that thought to be associated with primary dysmenorrhea, such as chronic pelvic pain occurring at times other than exclusively during menses and/or dyspareunia.
- Experiencing dysmenorrhea symptoms that are effects of or thought to be effects of (at least in part) secondary causes of dysmenorrhea, such as uterine fibroids, endometriosis, and/or currently symptomatic ovarian cysts.
- Experienced dysmenorrhea that did not require, in the opinion of the subject, the use of analgesic medication during four of the previous six menstrual episodes.
- Has dysmenorrhea refractory to treatment with commonly used analgesic medications for the treatment of menstrual pain (e.g., ibuprofen or naproxen sodium).
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 |
|---|---|---|
| LidocaineLidocaine vaginal gel 10% (150mg) administered once daily for 4 days | Drug | Active |
| PlaceboPlacebo vaginal gel administered once daily for 4 days | Drug | Placebo |
Primary outcome
The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.
Time frame: Two 4-day dosing regimens for two consecutive monthy menstrual cycles
Treatment-emgergent Adverse Events
Time frame: approximately two months, based on onset of menses
1 secondary outcome
Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing
Time frame: 7 hours following fourth dose in 2 consecutive menstrual cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George W Creasy, MD study director
Juniper Pharmaceuticals, Inc.
4 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 Lidocaine in people with Dysmenorrhea, run by Juniper Pharmaceuticals, Inc. at 4 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 9 inclusion and 19 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 6 Jul 2011). 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?
The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale. (time frame: Two 4-day dosing regimens for two consecutive monthy menstrual cycles). The study lists 2 primary outcomes in all. 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 17 Feb 2012.