Back to resultsSafety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
Primary Purpose
Uterine Fibroids
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Proellex
Proellex
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine fibroids
Eligibility Criteria
Inclusion Criteria:
- At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject must have uterine fibroid-associated symptoms during the-screening visit
- Subject has menstrual cycle lasting from 20 to 40 days
- Other inclusion criteria may apply
Exclusion Criteria:
- Post-menopausal women or women likely to become post-menopausal during the study
- Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- Subject who has had an acute illness within five days of study medication administration
- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
- Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
Sites / Locations
- Genesis Center for Clinical Research
- Physician Care Clinical Research, LLC
- Atlanta Women's Research Inst.
- Soapstone Center for Clinical Research
- York Clinical Consulting
- Female Pelvic Medicine
- Hawthorne Medical Research, Inc.
- Lyndhurst Gynecologic Associates
- Clinical Trials of America
- Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
- Women's Care Center, PLC Research Memphis Associates
- Meharry Medical College
- Willowbend Health & Wellness Associates
- Cepeme/Cerfahc
- Vox Femina
- Brazilmed
- Universidade Federal de São Paulo - UNIFESP
- Hospital dos Servidores Públicos de SP
- Hospital Heliópolis
- Hospital Santa Marcelina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
25 mg
50 mg
Arm Description
25 mg Proellex
50 mg Proellex
Outcomes
Primary Outcome Measures
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Secondary Outcome Measures
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00874302
Brief Title
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
Official Title
A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study terminated for safety and the FDA put the study on hold for safety.
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Detailed Description
Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 mg
Arm Type
Experimental
Arm Description
25 mg Proellex
Arm Title
50 mg
Arm Type
Experimental
Arm Description
50 mg Proellex
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
Telapristone acetate
Intervention Description
One 25mg capsule taken orally once every day.
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
Telapristone acetate
Intervention Description
Two 25mg capsules Proellex (50mg) taken orally once every day
Primary Outcome Measure Information:
Title
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Time Frame
Four months each cycle
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Time Frame
Two, 4 month cycles
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
Subject must have uterine fibroid-associated symptoms during the-screening visit
Subject has menstrual cycle lasting from 20 to 40 days
Other inclusion criteria may apply
Exclusion Criteria:
Post-menopausal women or women likely to become post-menopausal during the study
Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
Subject who has had an acute illness within five days of study medication administration
Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre van As, MD, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Physician Care Clinical Research, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Atlanta Women's Research Inst.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Soapstone Center for Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
York Clinical Consulting
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Female Pelvic Medicine
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hawthorne Medical Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lyndhurst Gynecologic Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Trials of America
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97408
Country
United States
Facility Name
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5127
Country
United States
Facility Name
Women's Care Center, PLC Research Memphis Associates
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Willowbend Health & Wellness Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Cepeme/Cerfahc
City
Curitiba
State/Province
Paraná.
ZIP/Postal Code
80030-220
Country
Brazil
Facility Name
Vox Femina
City
Jundiaí
ZIP/Postal Code
13209-000
Country
Brazil
Facility Name
Brazilmed
City
São Paulo
ZIP/Postal Code
01416-000
Country
Brazil
Facility Name
Universidade Federal de São Paulo - UNIFESP
City
São Paulo
ZIP/Postal Code
04015-001
Country
Brazil
Facility Name
Hospital dos Servidores Públicos de SP
City
São Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Hospital Heliópolis
City
São Paulo
ZIP/Postal Code
04230 - 000
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
São Paulo
ZIP/Postal Code
08270-070
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
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