Not provided
Not provided
Not provided
Not provided
Not provided
Business decision
Not provided
Not provided
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.
This study will be for participants who had completed either ZPV-201 or ZPU-203.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telapristone Acetate 12 mg | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telapristone acetate | Drug | Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Amenorrhea | 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. | At the end of 18 weeks Treatment Course 1 |
| Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2 | 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. |
Not provided
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 |
|---|---|---|---|---|---|---|
| KO Clinical Research, LLC | Fort Lauderdale | Florida | 33316 | United States | ||
| Atlanta Women's Research Institute, Inc. |
Participants who had successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] were enrolled in this study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telapristone Acetate 12 mg | Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Course 1 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8 | 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. | Baseline to the end of 18-weeks Treatment Course 1 |
| Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score | 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). | Baseline to the end of 18-weeks Treatment Course 1 |
| Percentage Change From Baseline in Total Uterine Fibroid Volume | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement. | Baseline to the end of 18-weeks Treatment Course 1 |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Southern Clinical Research Associates, LLC | Metairie | Louisiana | 70001 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |
| Advances in Health | Houston | Texas | 77030 | United States |
| The Women's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23235 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Course 2 |
|
Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telapristone Acetate 12 mg | Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Safety population included all study participants who were randomized, received study drug and had some post-baseline safety data. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Percentage of Participants in Amenorrhea | 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. | Intent-to-treat (ITT) population included all participants who received study drug. | Posted | Number | percentage of participants | At the end of 18 weeks Treatment Course 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8 | 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. | ITT population included all participants who received study drug. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score | 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). | ITT population Included all participants who received study drug. | Posted | Mean | Standard Deviation | score on a scale | Baseline to the end of 18-weeks Treatment Course 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline in Total Uterine Fibroid Volume | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement. | ITT population Included all participants who received study drug. MRI data was only available for 3 participants. | Posted | Mean | Standard Deviation | percent change | Baseline to the end of 18-weeks Treatment Course 1 |
|
|
From first dose of study drug through 30 days after the last dose of study drug (approximately 43 weeks)
Safety population consisted of all study participants who were randomized, received study drug and had some post-baseline safety data.
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 | Telapristone Acetate 12 mg | Telapristone acetate 12 mg, orally, once daily for two 18-weeks courses (Treatment Courses 1 and 2) separated by an off-drug interval (ODI). | 0 | 20 | 1 | 20 | 11 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hot flush | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Disorientation | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| May 29, 2019 |
| Prot_SAP_000.pdf |
| 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
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|