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The primary objective of this study is to determine the safety and efficacy of two vaginal 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
| Telapristone Acetate 6 mg | Experimental | Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
| Telapristone Acetate 12 mg | Experimental | Following the baseline assessment no treatment period, telapristone acetate 12mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding. | At the end of 18-weeks Treatment Course 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Chan | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Lauderdale | Florida | 33316 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| FG001 | Telapristone Acetate 6 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Course 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2016 | May 24, 2019 |
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| Telapristone Acetate | Drug | Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
| At the end of 18-weeks Treatment Course 2 |
| Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | 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 (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2 |
| Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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. | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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. | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
| Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement. | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2 |
| Sandy Springs |
| Georgia |
| 30328 |
| United States |
| Metairie | Louisiana | 70001 | United States |
| Saginaw | Michigan | 48604 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77054 | United States |
| Richmond | Virginia | 23235-4759 | United States |
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
| FG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment Course 2 |
|
|
Safety Population included all study participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| BG001 | Telapristone Acetate 6 mg | Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| BG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
| 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, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Safety Population included all study participants who received at least 1 dose of study treatment. | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Safety Population included all study participants who received at least 1 dose of study treatment. | 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 at the End of Treatment Course 1 | Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding. | Intent-to-Treat (ITT) population included all participants who were randomized and received study drug. | Posted | Number | percentage of participants | At the end of 18-weeks Treatment Course 1 |
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| Secondary | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding. | ITT population included all participants who were randomized and received study drug. | Posted | Number | percentage of participants | At the end of 18-weeks Treatment Course 2 |
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| Secondary | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | 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 were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in PBAC score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2 |
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| Secondary | Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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. | ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit | 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 consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in UFS-SSS score | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit |
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| Secondary | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement. | ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percentage change in fibroid volume | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2 |
|
From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety Population included all study participants who received at least 1 dose of study treatment.
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 | Placebo | Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. | 0 | 14 | 2 | 14 | 13 | 14 |
| EG001 | Telapristone Acetate 6 mg | Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. | 0 | 13 | 2 | 13 | 13 | 13 |
| EG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. | 0 | 15 | 2 | 15 | 11 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA, version 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 20.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA, version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Endocrine disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hot flush | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Metaplasia | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Asthma | Immune system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA, version 20.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA, version 20.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Bone density decreased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Libido increased | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vaginal infection | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pruritus genital | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dizziness | Vascular disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Migraine | Vascular disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, version 20.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2016 | May 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D005350 | Fibroma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C461063 | telapristone acetate |
Not provided
Not provided
Not provided
| Non-compliance |
|
|
|
|
| Native Hawaiian or Other Pacific Islander |
|
|
| White |
|
|
|
| Not Hispanic or Latino |
|
|
| Superiority |
|
|
|
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
| OG002 | Telapristone Acetate 12 mg | Following the baseline assessment no treatment period, telapristone acetate 12 mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI. |
|
|
|
|
|
|