A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease (FP1198-001)

May 25, 2010 updated by: FemmePharma Global Healthcare, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Evaluation of the Use of Topically Administered Danazol Versus Placebo in Subjects With Pain Associated With Fibrocystic Breast Disease

The purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.

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.

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 (Anticipated)

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.
60

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
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics, LLC
    • California
      • Beverly Hills, California, United States, 90211
        • Impact Clinical Trials
      • San Diego, California, United States, 92123
        • Women's Health Care at Frost Street
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • James A Simon, M.D., PC
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • Gainsville, Florida, United States, 32607
        • Southeastern Integrated Medical, LLC
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Roswell, Georgia, United States, 30075
        • Atlanta North Gynecology, PC
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice
      • Chicago, Illinois, United States, 60612
        • Center For Women's Research
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Physician's Research Group
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Kentucky Medical Research Center
    • Massachusetts
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • MedVadis Research Corporation
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Impact Clinical Trials
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley OB/GYN and Infertility Group, PC
      • Moorestown, New Jersey, United States, 08057
        • Phoenix Ob-Gyn Associates
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ Robert Wood Johnson Medica School Women's Health Institute
    • New York
      • New York, New York, United States, 10022-1009
        • Analgesic Development, Ltd.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102-1192
        • Drexel University College of Medicine
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Southeastern Clinical Research
      • Jackson, Tennessee, United States, 38305
        • Jackson Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78229
        • Seven Oaks Women's Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Menstruating females at least 18 years of age
  • Has moderate to severe breast pain associated with cyclical fibrocystic breast disease
  • Is in good general health

Exclusion Criteria:

  • Pregnant within the past 6 months or lactating
  • History of malignancy or currently being treated for cancer of the breast or genital organs
  • Has taken within the past 3 months or is currently taking hormonal contraception
  • Has any condition for which an androgen or steroid is contraindicated
  • Has had breast implants or breast reduction surgery

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: Quadruple

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: 2
Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Active Comparator: 1
Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Placebo Comparator: 4
Drug: Placebo
placebo topically applied once daily for 4 treatment cycles
Active Comparator: 3
Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Placebo Comparator: 5
Drug: Placebo
placebo topically applied once daily for 4 treatment cycles
Placebo Comparator: 6
Drug: Placebo
placebo topically applied once daily for 4 treatment cycles

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
Subject reported breast pain as measured using a visual analog scale on the subject daily diary
Time Frame: 2 cycles pretreatment plus 4 cycles on treatment
2 cycles pretreatment plus 4 cycles on treatment

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
Time Frame
Physician assessment of breast nodularity at each treatment cycle visit
Time Frame: 2 cycles pretreatment plus 4 cycles on treatment
2 cycles pretreatment plus 4 cycles on treatment

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.
FemmePharma Global Healthcare, 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: Peter K. Mays, Ph.D., FemmePharma Global Healthcare, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2007

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.
April 1, 2009

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.
June 1, 2009

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).
August 28, 2008

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.
August 28, 2008

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.
August 29, 2008

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.
May 27, 2010

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.
May 25, 2010

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.
May 1, 2010

More Information

Terms related to this study

Keywords

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.
  • FP1198-001

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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