Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)

NCT00651313 | Completed Phase 2 Results

• 1 other identifier: COL-1077-04
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Dysmenorrhea

Keywords

Dysmenorrhea; Periods; Menstrual; Primary dysmenorrhea in women with recurrent dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.

  Two 4-day dosing regimens for two consecutive monthy menstrual cycles

• Treatment-emgergent Adverse Events

  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

  7 hours following fourth dose in 2 consecutive menstrual cycles

Study Arms (2)

Active

ACTIVE COMPARATOR

Lidocaine 10% (150mg) vaginal gel

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Placebo vaginal gel

Drug: Placebo

Interventions

Lidocaine DRUG

Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days

Active

Placebo DRUG

Placebo vaginal gel administered once daily for 4 days

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juniper Pharmaceuticals, Inc.: lead

Study Sites (4)

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

SCIREX Research Center

Memphis, Tennessee, 38120, United States

Location

SCIREX Research Center

Austin, Texas, 78705, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: George W. Creasy, MD Vice President, Clinical Research
• Organization: Columbia Laboratories, Inc.

gcreasy@columbialabs.com

973-486-8797

Study Officials

• George W Creasy, MD

  Juniper Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 2, 2008
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 17, 2012
• Results First Posted: July 6, 2011

Record last verified: 2012-02

Locations

US (4)