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Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

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ClinicalTrials.gov Identifier: NCT00958334
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : January 7, 2011
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Uterine Fibroids
Interventions Drug: Proellex®
Drug: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Hide Arm/Group Description Proellex® 12.5 mg orally capsules BID Proellex® 12.5 mg capsules orally QD Placebo capsules orally QD
Period Title: Overall Study
Started 22 22 21
Completed 8 5 8
Not Completed 14 17 13
Arm/Group Title Proellex 25 mg Proellex 12.5 mg Placebo Comparator Total
Hide Arm/Group Description Proellex® 12.5 mg twice daily Proellex® 12.5 mg once daily Placebo capsule once daily Total of all reporting groups
Overall Number of Baseline Participants 22 22 21 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 21 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
21
 100.0%
65
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 21 participants 65 participants
41.5  (5.55) 42.6  (5.38) 40.6  (6.48) 41.6  (5.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 21 participants 65 participants
Female
22
 100.0%
22
 100.0%
21
 100.0%
65
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 21 participants 65 participants
22 22 21 65
1.Primary Outcome
Title The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.
Hide Description An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
Time Frame baseline, 14 months (3-4 cycles), 17 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Hide Arm/Group Description:
Proellex® 12.5 mg twice daily
Proellex® 12.5 mg once daily
Placebo capsule once daily
Overall Number of Participants Analyzed 22 22 21
Mean (Standard Deviation)
Unit of Measure: mL
Baseline 136.29  (88.12) 179.95  (119.83) 130.86  (147.10)
Change from baseline to end of ODI 1 -41.00  (71.63) -63.57  (100.83) NA [1]   (0000)
Change from baseline to end of ODI 2 -38.60  (213.63) -33.33  (240.42) -9.90  (125.88)
Change from baseline to end of ODI 3 -7.00  (69.63) -222.50  (121.62) -31.29  (175.46)
Change from baseline to end of ODI 4 NA [2]   (0000) -48.00  (11.31) NA [2]   (0000)
Change from baseline to 17 months 1.43  (94.09) -211.40  (148.06) 17.50  (192.88)
[1]
No data change for subjects randomized to placebo group at the end of ODI 1
[2]
Statistical analysis not completed due to low number of subjects having ODI 4
2.Secondary Outcome
Title Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only)
Hide Description [Not Specified]
Time Frame baseline and 14 months
Outcome Measure Data Not Reported
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Hide Arm/Group Description Proellex® 12.5 mg twice daily Proellex® 12.5 mg once daily Placebo capsule once daily
All-Cause Mortality
Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      1/22 (4.55%)      1/21 (4.76%)    
Gastrointestinal disorders       
Colitis  1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Hepatobiliary disorders       
Autoimmune hepatitis  1  1/22 (4.55%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Reproductive system and breast disorders       
Ovarian cyst ruptured  1  0/22 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1
Vascular disorders       
Uterine Haemorrhage  1  0/22 (0.00%)  0 1/22 (4.55%)  2 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Proellex 25 mg Proellex 12.5 mg Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/22 (86.36%)      18/22 (81.82%)      19/21 (90.48%)    
Blood and lymphatic system disorders       
anemia  1  1/22 (4.55%)  1/22 (4.55%)  1/21 (4.76%) 
Gastrointestinal disorders       
nausea  1  2/22 (9.09%)  3/22 (13.64%)  3/21 (14.29%) 
abdominal pain  1  1/22 (4.55%)  1/22 (4.55%)  1/21 (4.76%) 
diarrhea  1  1/22 (4.55%)  1/22 (4.55%)  1/21 (4.76%) 
vomiting  1  0/22 (0.00%)  3/22 (13.64%)  0/21 (0.00%) 
abdominal distension  1  1/22 (4.55%)  0/22 (0.00%)  1/21 (4.76%) 
colitis  1  2/22 (9.09%)  0/22 (0.00%)  0/21 (0.00%) 
constipation  1  1/22 (4.55%)  0/22 (0.00%)  1/21 (4.76%) 
General disorders       
hot flush  1 [1]  5/22 (22.73%)  5/22 (22.73%)  8/21 (38.10%) 
fatigue  1  1/22 (4.55%)  1/22 (4.55%)  1/21 (4.76%) 
Infections and infestations       
urinary tract infection  1  0/22 (0.00%)  0/22 (0.00%)  5/21 (23.81%) 
influenza  1  3/22 (13.64%)  1/22 (4.55%)  3/21 (14.29%) 
Injury, poisoning and procedural complications       
joint sprain  1  1/22 (4.55%)  1/22 (4.55%)  1/21 (4.76%) 
Investigations       
hepatic enzyme increased  1  0/22 (0.00%)  1/22 (4.55%)  2/21 (9.52%) 
blood cholesterol increased  1  2/22 (9.09%)  0/22 (0.00%)  0/21 (0.00%) 
prothrombin level increased  1  1/22 (4.55%)  1/22 (4.55%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders       
arthralgia  1  3/22 (13.64%)  2/22 (9.09%)  1/21 (4.76%) 
back pain  1  1/22 (4.55%)  0/22 (0.00%)  2/21 (9.52%) 
pain in extremity  1  2/22 (9.09%)  0/22 (0.00%)  1/21 (4.76%) 
myalgia  1  0/22 (0.00%)  2/22 (9.09%)  0/21 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
uterine polyp  1  1/22 (4.55%)  1/22 (4.55%)  0/21 (0.00%) 
Nervous system disorders       
headache  1 [2]  7/22 (31.82%)  2/22 (9.09%)  5/21 (23.81%) 
dizziness  1  2/22 (9.09%)  2/22 (9.09%)  0/21 (0.00%) 
carpal tunnel syndrome  1  2/22 (9.09%)  1/22 (4.55%)  0/21 (0.00%) 
Psychiatric disorders       
anxiety  1  2/22 (9.09%)  1/22 (4.55%)  0/21 (0.00%) 
depression  1  1/22 (4.55%)  0/22 (0.00%)  1/21 (4.76%) 
Reproductive system and breast disorders       
endometrial thickening  1  8/22 (36.36%)  6/22 (27.27%)  2/21 (9.52%) 
amenorrhea  1  5/22 (22.73%)  4/22 (18.18%)  6/21 (28.57%) 
menorrhagia/uterine hemorrhage/metorrhagia  1  4/22 (18.18%)  3/22 (13.64%)  2/21 (9.52%) 
ovarian cyst  1  3/22 (13.64%)  3/22 (13.64%)  1/21 (4.76%) 
vulvovaginal mycotic infection  1  2/22 (9.09%)  0/22 (0.00%)  2/21 (9.52%) 
breast tenderness  1  3/22 (13.64%)  2/22 (9.09%)  0/21 (0.00%) 
dysmenorrhoea  1  2/22 (9.09%)  1/22 (4.55%)  0/21 (0.00%) 
breast cyst  1  1/22 (4.55%)  0/22 (0.00%)  1/21 (4.76%) 
cervical dysplasia  1  1/22 (4.55%)  1/22 (4.55%)  0/21 (0.00%) 
pelvic pain  1  0/22 (0.00%)  1/22 (4.55%)  1/21 (4.76%) 
vaginitis bacterial  1  1/22 (4.55%)  0/22 (0.00%)  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders       
upper respiratory tract infection  1  0/22 (0.00%)  0/22 (0.00%)  5/21 (23.81%) 
Skin and subcutaneous tissue disorders       
acne  1  1/22 (4.55%)  1/22 (4.55%)  0/21 (0.00%) 
dermal cyst  1  0/22 (0.00%)  1/22 (4.55%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Hot flush
[2]
headache, dizziness,carpal tunnel syndrome
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Ronald Wiehle, PhD
Organization: Repros Therapeutics, Inc
Phone: 281.719.3406
Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00958334     History of Changes
Other Study ID Numbers: ZPU-003 Ext
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: August 26, 2010
Results First Posted: January 7, 2011
Last Update Posted: August 8, 2014