Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods) (Lidocaine 04)
This study has been completed.
Information provided by (Responsible Party):
First received: March 28, 2008
Last updated: February 16, 2012
Last verified: February 2012
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).
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Treatment-emgergent Adverse Events [ Time Frame: approximately two months, based on onset of menses ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
Active Comparator: Active
Lidocaine 10% (150mg) vaginal gel
Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
Placebo Comparator: Placebo
Placebo vaginal gel
Placebo vaginal gel administered once daily for 4 days
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.
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651313
|Lyndhurst Gynecologic Associates
|Winston-Salem, North Carolina, United States, 27103 |
|SCIREX Research Center
|Memphis, Tennessee, United States, 38120 |
|SCIREX Research Center
|Austin, Texas, United States, 78705 |
|Jean Brown Research
|Salt Lake City, Utah, United States, 84124 |
||George W Creasy, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2008
|Results First Received:
||June 7, 2011
||February 16, 2012
||United States: Food and Drug Administration
Keywords provided by Columbia Laboratories:
Primary dysmenorrhea in women with recurrent dysmenorrhea
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents