Moderate to Severe Cyclic MastalgiaPhase 2NCT01105793
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
A Phase 2 study testing Danazol in people with Moderate to Severe Cyclic Mastalgia, run by FemmePharma Global Healthcare, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Cyclic Mastalgia
- What is being tested?
- Danazol
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- menstruating females at least 18 years of age
- BMI less than 30
- moderate to severe breast pain associated with the menstrual cycle
- in good general health
Who cannot join
- pregnant within the last 6 months
- has taken in the last 3 months or currently taking hormonal contraception
- history of malignancy or currently being treated for cancer of the breast or genital organs
- has had breast implants or breast reduction surgery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Horizons Clinical Research
Denver, Colorado, 80220
Kentucky Medical Research Center
Lexington, Kentucky, 40504
Salt Lake Research
Salt Lake City, Utah, 84107
Women's Health Care
San Diego, California, 92123
About this study
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
- Conditions
- Moderate to Severe Cyclic Mastalgia
- Being tested
- Danazol
- Keywords
- cyclic mastalgia, cyclic breast pain, fibrocystic breast disease
- Medical subject headings
- Fibrocystic Breast Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanazolDrug
High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in breast pain
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Cyclic MastalgiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FemmePharma Global Healthcare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105793
- Sponsor's protocol ID
- FP1198-002
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2010
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
- ClinicalTrials.gov ID
- NCT01105793
- Acronym / sponsor ID
- FP1198-002
- Conditions
- Moderate to Severe Cyclic Mastalgia
- Keywords
- cyclic mastalgia, cyclic breast pain, fibrocystic breast disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- FemmePharma Global Healthcare, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Apr 2010 (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 topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- menstruating females at least 18 years of age
- BMI less than 30
- moderate to severe breast pain associated with the menstrual cycle
- in good general health
Key exclusion criteria (4 listed)
- pregnant within the last 6 months
- has taken in the last 3 months or currently taking hormonal contraception
- history of malignancy or currently being treated for cancer of the breast or genital organs
- 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 |
|---|---|---|
| DanazolHigh dose FP1198 applied once daily to both breasts for 6 treatment cycles. | Drug | – |
Primary outcome
Reduction in breast pain
Time frame: six months
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 26 Oct 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Danazol in people with Moderate to Severe Cyclic Mastalgia, run by FemmePharma Global Healthcare, 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 4 inclusion and 4 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 26 Oct 2011. 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. 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?
Reduction in breast pain (time frame: six months). 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 26 Oct 2011.