- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301897
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
May 29, 2019 updated by: Repros Therapeutics Inc.
A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
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
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Alabama
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Birmingham, Alabama, United States, 35235
- Alabama Clinical Therapeutics, LLC
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Arizona
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Phoenix, Arizona, United States, 85015
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Scottsdale, Arizona, United States, 85251
- MomDoc Women's Health Research
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Florida
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Fort Lauderdale, Florida, United States, 33316
- KO Clinical Research, LLC
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Margate, Florida, United States, 33063
- South Florida Clinical Research Institute
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Georgia
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Atlanta, Georgia, United States, 30342
- Atlanta Women's Research Institute, Inc.
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Augusta, Georgia, United States, 30912
- Augusta University
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Sandy Springs, Georgia, United States, 30328
- WR-Mount Vernon Clinical Research, LLC
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Louisiana
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Metairie, Louisiana, United States, 70001
- Southern Clinical Research Associates, LLC
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South Carolina
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Summerville, South Carolina, United States, 29485
- Palmetto Clinical Research
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Tennessee
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Jackson, Tennessee, United States, 38305
- The Jackson Clinic, PA
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Knoxville, Tennessee, United States, 37920
- Volunteer Research Group
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Texas
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Dallas, Texas, United States, 75231
- DCT-HCWC, LLC dba Discovery Clinical Trials
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Houston, Texas, United States, 77030
- Advances In Health
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Houston, Texas, United States, 77054
- The Women's Hospital of Texas Clinical Research Center
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Virginia
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Richmond, Virginia, United States, 23235
- Clinical Research Partners, LLC
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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 to 47 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Is a pre-menopausal female, between 18 and 47 years
- Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
- Confirmed uterine fibroid(s) at screening
- Visit 1 historical pictorial blood loss assessment chart of >120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).
- A Body Mass Index (BMI) between 18 and 45 inclusive
Exclusion Criteria:
- Participant is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
- Received an investigational drug in the 30 days prior to the screening for this study
- Has an intrauterine device in place
- Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia
- Participants with abnormally high liver enzymes or liver disease
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 |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
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Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Other Names:
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Experimental: Telapristone Acetate 6 mg
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
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Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Other Names:
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Experimental: Telapristone Acetate 12 mg
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
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Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants in Amenorrhea at the End of Treatment Course 1
Time Frame: At the end of 18-weeks Treatment Course 1
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Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
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At the end of 18-weeks Treatment Course 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants in Amenorrhea at the End of Treatment Course 2
Time Frame: At the end of 18-weeks Treatment Course 2
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Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
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At the end of 18-weeks Treatment Course 2
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Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
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Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots).
Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size.
Total score can range from 0 (no bleeding) to >500.
Higher scores indicate more bleeding.
Lower scores indicate less bleeding.
A negative change from Baseline indicates improvement (reduction in bleeding).
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
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Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
|
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots).
Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size.
Total score can range from 0 (no bleeding) to >500.
Higher scores indicate more bleeding.
Lower scores indicate less bleeding.
A negative percentage change from Baseline indicates improvement (reduction in bleeding).
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
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Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal.
The sum of total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst).
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent nighttime urination"? using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire.
The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"?
using a 5-point scale where 1=Not at all to 5=A very great deal.
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
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Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
Time Frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drug
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The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI).
A negative percentage change from Baseline indicates improvement.
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Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
March 16, 2015
Primary Completion (Actual)
June 2, 2017
Study Completion (Actual)
June 2, 2017
Study Registration Dates
First Submitted
November 24, 2014
First Submitted That Met QC Criteria
November 25, 2014
First Posted (Estimate)
November 26, 2014
Study Record Updates
Last Update Posted (Actual)
June 19, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZPU-203
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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