Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proellex 25 mg | Experimental | Two Proellex® 12.5 mg capsules once daily |
|
| Proellex 12.5 mg | Experimental | One Proellex® 12.5 mg capsules once daily |
|
| Placebo | Placebo Comparator | Capsule once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proellex® | Drug | 25 mg daily (two 12.5 mg capsules) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to 17 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna Chan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Research | Phoenix | Arizona | 85015 | United States | ||
| Arizona Wellness Centre for Women |
ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Proellex 25 mg | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. |
| FG001 | Proellex 12.5 mg Then 25 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 14 months, 17 months |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Medical Centre for Clinical Research | San Diego | California | 92108 | United States |
| Women's Health Care, Inc. | San Diego | California | 92123 | United States |
| Downtown Women's Health Care | Denver | Colorado | 80218 | United States |
| Insignia Clinical Research (Tampa Bay Women's Center) | Tampa | Florida | 33607 | United States |
| Affiliated Clinical Research, Inc. | Las Vegas | Nevada | 89128 | United States |
| SC Clinical Research Center | Columbia | South Carolina | 29201 | United States |
| Advances in Health Inc. | Houston | Texas | 77030 | United States |
| Obstetrical & Gynecolgical Associates, PA (OGA) | Houston | Texas | 77054 | United States |
| Women's Clinical Research Centre | Seattle | Washington | 98105 | United States |
Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| FG002 | Placebo, Then 25 mg Proellex | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| COMPLETED |
|
| NOT COMPLETED |
|
Analyses done on ITT Population. ZPU-003 EXT was an open-label extension study of ZPU-003, all patients received active medication (25 mg of Proellex). Results were summarized as follows - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Proellex 25 mg | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. |
| BG001 | Proellex 12.5 mg Then 25 mg | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| BG002 | Placebo, Then 25 mg Proellex | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Intent to treat population | Posted | Mean | Standard Deviation | mL | Baseline to 17 months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. | Intent to treat population | Posted | Mean | Standard Deviation | mL of Blood | Baseline, 14 months, 17 months |
|
24 months
ZPU-003 EXT was an open-label extension study of ZPU-003 (NCT00882258) and all patients received active medication (25 mg of Proellex); however, results were summarized according to the following groups - subjects who previously received active drug, by dose (12.5 mg and 25 mg) and subjects who previously received placebo in the double-blind ZPU-003 study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proellex 25 mg | Participants received Proellex 25 mg by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. PI discretion to decrease dose to 12.5mg if warranted. | 2 | 22 | 19 | 22 | ||
| EG001 | Proellex 12.5 mg Then 25 mg | Participants received Proellex 12.5 mg. capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | 1 | 22 | 18 | 22 | ||
| EG002 | Placebo, Then 25 mg Proellex | Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. | 1 | 21 | 19 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Uterine Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hot flush | General disorders | MedDRA (Unspecified) | Systematic Assessment | Hot flush |
|
| headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | headache, dizziness,carpal tunnel syndrome |
|
| nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| hepatic enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| joint sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| uterine polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| endometrial thickening | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| amenorrhea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| menorrhagia/uterine hemorrhage/metorrhagia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| ovarian cyst | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| vulvovaginal mycotic infection | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| breast tenderness | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| carpal tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| dysmenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| breast cyst | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| cervical dysplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| pelvic pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| vaginitis bacterial | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| blood cholesterol increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| prothrombin level increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C461063 | telapristone acetate |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Change from baseline to end of ODI 1 |
|
|
| Change from baseline to end of ODI 2 |
|
|
| Change from baseline to end of ODI 3 |
|
|
| Change from baseline to end of ODI 4 |
|
|
| Change from baseline to 17 months |
|
|
| Placebo, Then 25 mg Proellex |
Participants received Placebo capsule by oral administration once per day in NCT00882258. In this extension study participants receive 25 mg Proellex by oral administration of two 12.5 mg capsules. |
|
|