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An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811159
Recruitment Status : Terminated (Business decision)
First Posted : June 23, 2016
Results First Posted : June 19, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE June 21, 2016
First Posted Date  ICMJE June 23, 2016
Results First Submitted Date  ICMJE May 29, 2019
Results First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE July 26, 2016
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Percentage of Participants in Amenorrhea [ Time Frame: At the end of 18 weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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 the 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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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 night time 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.
  • Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8 [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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.
  • Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    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).
  • Percentage Change From Baseline in Total Uterine Fibroid Volume [ Time Frame: Baseline to the end of 18-weeks Treatment Course 1 ]
    The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • Percentage of subjects who become amenorrheic over the course of the study [ Time Frame: 13 months ]
  • Change in UFS-QOL Symptom Severity score comparing to the previous study baseline and study baseline [ Time Frame: 13 months ]
  • Change in the individual UFS-QOL sub scores [ Time Frame: 13 months ]
  • Change in PBAC scores [ Time Frame: 13 months ]
  • Percentage change from parent study baseline and study baseline in total uterine fibroid volume measured by MRI [ Time Frame: 13 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Official Title  ICMJE An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Brief Summary To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.
Detailed Description This study will be for participants who had completed either ZPV-201 or ZPU-203.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE Drug: Telapristone acetate
Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.
Other Name: Proellex®
Study Arms  ICMJE Experimental: Telapristone Acetate 12 mg
Telapristone acetate 12 milligrams (mg), orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI).
Intervention: Drug: Telapristone acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2016)
60
Actual Study Completion Date  ICMJE May 4, 2017
Actual Primary Completion Date May 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897]
  • Agreement not to attempt to become pregnant during the trial
  • Agreement to use alcohol in moderation and record the daily consumption (note: elevated liver enzymes may result in discontinuation from the study)
  • Ability to complete a daily subject diary and study procedures in compliance with the protocol
  • Women of child-bearing potential must be willing to use double-barrier contraception during the study and off-drug intervals. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide
  • Has a negative pregnancy test at Visit 1
  • Subject is available for all treatment and follow-up visits

Exclusion Criteria:

  • Subject had a significant decrease in bone mineral density while participating in ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)
  • Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in ZPV-201 or ZPU-203
  • Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
  • Subjects with abnormally high liver enzymes or liver disease. [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on repeat].
  • Subject has a hemoglobin of <7.5 grams per deciliter (g/dL) at Visit 1
  • Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit 1
  • Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in the preceding 10 months
  • Use of Gonadotrophin releasing hormone agonist (GnRHas) (e.g. Lupron Depot) within 3 months prior to screening (Lupron Depot must have a wash-out period of 3 months prior to screening)
  • Has an intra-uterine device (IUD) in place
  • Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV)
  • Current diagnosis of Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL), endometrial polyps or hyperplasia
  • Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia (EIN)
  • Recent history (within past 6 months) of alcoholism or drug abuse
  • Endometrial stripe ≥18 mm in thickness at Visit 1 (subject may be enrolled with sponsor approval)
  • Subject is currently taking cimetidine or spironolactone or has taken them in the last 30 days
  • Clinically significant abnormal findings on Visit 1 examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the subject's ability to comply with the study instructions or endanger the subject if she took part in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 47 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02811159
Other Study ID Numbers  ICMJE ZPU-203EXT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repros Therapeutics Inc.
Study Sponsor  ICMJE Repros Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anna Chan Allergan
PRS Account Repros Therapeutics Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP