- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105793
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
October 25, 2011 updated by: FemmePharma Global Healthcare, Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- 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
-
-
California
-
San Diego, California, United States, 92123
- Women's Health Care
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Horizons Clinical Research
-
-
Kentucky
-
Lexington, Kentucky, United States, 40504
- Kentucky Medical Research Center
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Salt Lake Research
-
-
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
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
- BMI less than 30
- moderate to severe breast pain associated with the menstrual cycle
- in good general health
Exclusion Criteria:
- 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
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in breast pain
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
June 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 13, 2010
First Submitted That Met QC Criteria
April 15, 2010
First Posted (Estimate)
April 16, 2010
Study Record Updates
Last Update Posted (Estimate)
October 26, 2011
Last Update Submitted That Met QC Criteria
October 25, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP1198-002
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.
Clinical Trials on Moderate to Severe Cyclic Mastalgia
-
ASCEND TherapeuticsCompletedCyclic Breast Pain, Cyclic Mastalgia
-
Beer, Kenneth R., M.D., PAMedicis Pharmaceutical CorporationCompletedMild to Moderate Temporal Atrophy | Moderate to Severe Glabellar Rhytids | Moderate to Severe Periorbital RhytidsUnited States
-
Aqpha Medical B.V.Not yet recruitingModerate to Severe Nasolabial Fold
-
Daewoong Pharmaceutical Co. LTD.Completed
-
Galderma R&DCompletedModerate to Severe Glabellar LinesChina
-
EuBiologics Co.,LtdCompletedModerate to Severe Glabellar LinesKorea, Republic of
-
AllerganCompletedModerate to Severe Nasolabial FoldsGermany, Netherlands
-
IpsenCompletedModerate to Severe Glabellar LinesFrance, Germany
-
Daewoong Pharmaceutical Co. LTD.CompletedModerate to Severe Glabellar LineKorea, Republic of
-
JHM BioPharma (Tonghua) Co. , Ltd.Recruiting
Clinical Trials on Danazol
-
Peking Union Medical College HospitalUnknownLow/Intermediate Risk-1 MDSChina
-
Lumara Health, Inc.Completed
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedEndometrial CancerUnited States, Canada
-
FemmePharma Global Healthcare, Inc.CompletedFibrocystic Disease of BreastUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownTelomere Length, Mean Leukocyte | Telomere Shortening
-
Seoul National University HospitalKyowa Kirin Korea Co., Ltd.Unknown
-
University of Southern CaliforniaRecruitingCirrhosis, Liver | CytopeniaUnited States
-
Brigham and Women's HospitalWithdrawnLung Transplant | Short Telomere Length
-
Boston Children's HospitalTerminatedFanconi Anemia | Dyskeratosis CongenitaUnited States
-
IVI MadridCompleted