Fibrocystic Disease of BreastPhase 2FP1198-001NCT00744276
A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
A Phase 2 study testing danazol in people with Fibrocystic Disease of Breast, run by FemmePharma Global Healthcare, Inc. at 30 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibrocystic Disease of Breast
- What is being tested?
- danazol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 30 sitesUnited States
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Impact Clinical Trials
Beverly Hills, California, 90211
Visions Clinical Research
Boynton Beach, Florida, 33437
Women's Health Practice
Champaign, Illinois, 61820
Southeastern Clinical Research
Chattanooga, Tennessee, 37403
Center for Women's Research
Chicago, Illinois, 60612
Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Southeastern Integrated Medical, LLC
Gainsville, Florida, 32607
Physician's Research Group
Indianapolis, Indiana, 46250
Jackson Clinic
Jackson, Tennessee, 38305
Impact Clinical Trials
Las Vegas, Nevada, 89106
Delaware Valley OB/GYN and Infertility Group, PC
Lawrenceville, New Jersey, 08648
Kentucky Medical Research Center
Lexington, Kentucky, 40504
Phoenix OB-GYN Associates
Moorestown, New Jersey, 08057
UMDNJ Robert Wood Johnson Medica School Women's Health Institute
New Brunswick, New Jersey, 08901
Analgesic Development, Ltd.
New York, New York, 10022-1009
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102-1192
Women's Health Research
Phoenix, Arizona, 85015
Virginia Women's Center
Richmond, Virginia, 23233
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Atlanta North Gynecology, PC
Roswell, Georgia, 30075
Salt Lake Research
Salt Lake City, Utah, 84107
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Seven Oaks Women's Center
San Antonio, Texas, 78229
Women's Health Care at Frost Street
San Diego, California, 92123
Women's Clinical Research Center
Seattle, Washington, 98105
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85712
James A Simon, M.D., PC
Washington D.C., District of Columbia, 20036
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481-2106
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: 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.
- Conditions
- Fibrocystic Disease of Breast
- Being tested
- danazol, Placebo
- Keywords
- fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease
- Medical subject headings
- Fibrocystic Breast Disease, Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
danazolDrug
danazol applied topically once per day for 4 treatment cycles
PlaceboDrug
placebo topically applied once daily for 4 treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: danazol |
| 2 | Active comparator | Not described Receives: Drug: danazol |
| 3 | Active comparator | Not described Receives: Drug: danazol |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
| 6 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject reported breast pain as measured using a visual analog scale on the subject daily diary
Measured: 2 cycles pretreatment plus 4 cycles on treatment
Secondary outcomes (1)
Physician assessment of breast nodularity at each treatment cycle visit
Measured: 2 cycles pretreatment plus 4 cycles on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fibrocystic Disease of BreastStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FemmePharma Global Healthcare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter K. Mays, Ph.D., Study director, FemmePharma Global Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744276
- Sponsor's protocol ID
- FP1198-001
- Acronym
- FP1198-001
- Status last verified
- May 2010
- First submitted
- 28 Aug 2008
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes LE, Mansel RE, Webster DJ. Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomenclature of benign breast disorders. Lancet. 1987 Dec 5;2(8571):1316-9. doi: 10.1016/s0140-6736(87)91204-9.
PubMed 2890912Panahy C, Puddefoot JR, Anderson E, Vinson GP, Berry CL, Turner MJ, Brown CL, Goode AW. Effects of danazol on incidence of progesterone and oestrogen receptors in benign breast disease. Br Med J (Clin Res Ed). 1987 Aug 22;295(6596):464-6. doi: 10.1136/bmj.295.6596.464.
PubMed 3117172Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.
PubMed 2364227Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.
PubMed 2406750Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin. 2004 May;20(5):681-4. doi: 10.1185/030079904125003377.
PubMed 15140333Vaidyanathan L, Barnard K, Elnicki DM. Benign breast disease: when to treat, when to reassure, when to refer. Cleve Clin J Med. 2002 May;69(5):425-32. doi: 10.3949/ccjm.69.5.425.
PubMed 12022387Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.
PubMed 571588Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.
PubMed 3902125Gledhill JM, Barker S, Wanless C, Hinson JP, Puddefoot JR, Panahy C, Goode AW, Vinson GP. Progesterone receptor induction by danazol in cultured cancer cells and the rat uterus. J Steroid Biochem Mol Biol. 1992 Oct;43(4):289-96. doi: 10.1016/0960-0760(92)90163-d.
PubMed 1390280
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00744276
- Acronym / sponsor ID
- FP1198-001 / FP1198-001
- Conditions
- Fibrocystic Disease of Breast
- Keywords
- fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- FemmePharma Global Healthcare, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: danazol |
| 2 | Active comparator | Drug: danazol |
| 3 | Active comparator | Drug: danazol |
| 4 | Placebo comparator | Drug: Placebo |
| 5 | Placebo comparator | Drug: Placebo |
| 6 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| danazoldanazol applied topically once per day for 4 treatment cycles | Drug | 1, 2, 3 |
| Placeboplacebo topically applied once daily for 4 treatment cycles | Drug | 4, 5, 6 |
Primary outcome
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
1 secondary outcome
Physician assessment of breast nodularity at each treatment cycle visit
Time frame: 2 cycles pretreatment plus 4 cycles on treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Background: PubMed 2890912Hughes LE, Mansel RE, Webster DJ. Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomenclature of benign breast disorders. Lancet. 1987 Dec 5;2(8571):1316-9. doi: 10.1016/s0140-6736(87)91204-9.
- Background: PubMed 3117172Panahy C, Puddefoot JR, Anderson E, Vinson GP, Berry CL, Turner MJ, Brown CL, Goode AW. Effects of danazol on incidence of progesterone and oestrogen receptors in benign breast disease. Br Med J (Clin Res Ed). 1987 Aug 22;295(6596):464-6. doi: 10.1136/bmj.295.6596.464.
- Background: PubMed 2364227Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.
- Background: PubMed 2406750Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.
- Background: PubMed 15140333Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin. 2004 May;20(5):681-4. doi: 10.1185/030079904125003377.
- Background: PubMed 12022387Vaidyanathan L, Barnard K, Elnicki DM. Benign breast disease: when to treat, when to reassure, when to refer. Cleve Clin J Med. 2002 May;69(5):425-32. doi: 10.3949/ccjm.69.5.425.
- Background: PubMed 571588Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.
- Background: PubMed 3902125Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.
- Background: PubMed 1390280Gledhill JM, Barker S, Wanless C, Hinson JP, Puddefoot JR, Panahy C, Goode AW, Vinson GP. Progesterone receptor induction by danazol in cultured cancer cells and the rat uterus. J Steroid Biochem Mol Biol. 1992 Oct;43(4):289-96. doi: 10.1016/0960-0760(92)90163-d.
- General breast health informationLink provided by the sponsor.
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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.
Peter K. Mays, Ph.D. study director
FemmePharma Global Healthcare, Inc.
30 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 danazol in people with Fibrocystic Disease of Breast, run by FemmePharma Global Healthcare, Inc. at 30 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 3 inclusion and 5 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 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744276, which also lists 9 linked publications.
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 27 May 2010.