Uterine Fibroids
Conditions
Brief summary
The primary objective of this study is to determine the safety and efficacy of two oral 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.
Interventions
Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
DRUGPlacebo
Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* Is a pre-menopausal female, between 18 and 47 years * Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids * Confirmed uterine fibroid(s) at screening * Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period). * A Body Mass Index (BMI) between 18 and 45 inclusive
Exclusion criteria
* Participant is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period * Received an investigational drug in the 30 days prior to the screening for this study * Has an intrauterine device in place * Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia * Participants with abnormally high liver enzymes or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | At the end of 18-weeks Treatment Course 1 | Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit | Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to \>500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding). |
| Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit | 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 percentage change from Baseline indicates improvement (reduction in bleeding). |
| Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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 total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement. |
| Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drug | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | At the end of 18-weeks Treatment Course 2 | Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
| Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telapristone Acetate 6 mg Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI). | 12 |
| Telapristone Acetate 12 mg Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI. | 17 |
| Placebo Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI. | 14 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Course 1 | Adverse Event | 1 | 1 | 0 |
| Treatment Course 1 | Lost to Follow-up | 1 | 2 | 1 |
| Treatment Course 1 | Non-Compliance | 0 | 0 | 1 |
| Treatment Course 1 | Other Miscellaneous Reasons | 1 | 0 | 0 |
| Treatment Course 1 | Withdrawal by Sponsor | 0 | 0 | 2 |
| Treatment Course 1 | Withdrawal by Subject | 0 | 0 | 2 |
| Treatment Course 2 | Lost to Follow-up | 0 | 2 | 0 |
| Treatment Course 2 | Other Miscellaneous Reasons | 1 | 0 | 0 |
| Treatment Course 2 | Pregnancy | 0 | 1 | 1 |
| Treatment Course 2 | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Telapristone Acetate 6 mg | Telapristone Acetate 12 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 40.8 years | 41.4 years | 41.9 years | 41.4 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 14 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 17 | 0 / 14 |
| other Total, other adverse events | 10 / 12 | 15 / 17 | 12 / 14 |
| serious Total, serious adverse events | 1 / 12 | 1 / 17 | 0 / 14 |
Outcome results
Primary
Percentage of Participants in Amenorrhea at the End of Treatment Course 1
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Time frame: At the end of 18-weeks Treatment Course 1
Population: Intent-to-treat (ITT) population consisted of all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telapristone Acetate 6 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 58.33 percentage of participants |
| Telapristone Acetate 12 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 70.59 percentage of participants |
| Placebo | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 0.0 percentage of participants |
p-value: 0.0008Chi-Square Test
p-value: <0.001Chi-Square Test
Secondary
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
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).
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Baseline | 316.82 score on a scale | Standard Deviation 162.828 |
| Telapristone Acetate 6 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Week 18 Course 2 | -323.20 score on a scale | Standard Deviation 138.553 |
| Telapristone Acetate 6 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to ODI Course 1 | -100.92 score on a scale | Standard Deviation 238.412 |
| Telapristone Acetate 6 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Course 2 Week 28 FU | -220.50 score on a scale | Standard Deviation 137.805 |
| Telapristone Acetate 6 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Change from Baseline (CFB) to Week 18 Course 1 | -340.61 score on a scale | Standard Deviation 151.198 |
| Telapristone Acetate 12 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Course 2 Week 28 FU | -655.33 score on a scale | Standard Deviation 466.031 |
| Telapristone Acetate 12 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Baseline | 371.20 score on a scale | Standard Deviation 332.028 |
| Telapristone Acetate 12 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Change from Baseline (CFB) to Week 18 Course 1 | -364.55 score on a scale | Standard Deviation 342.572 |
| Telapristone Acetate 12 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to ODI Course 1 | -127.41 score on a scale | Standard Deviation 282.914 |
| Telapristone Acetate 12 mg | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Week 18 Course 2 | -396.69 score on a scale | Standard Deviation 367.242 |
| Placebo | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Change from Baseline (CFB) to Week 18 Course 1 | -44.48 score on a scale | Standard Deviation 468.771 |
| Placebo | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Course 2 Week 28 FU | -324.70 score on a scale | Standard Deviation 109.884 |
| Placebo | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to Week 18 Course 2 | -238.86 score on a scale | Standard Deviation 164.498 |
| Placebo | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | Baseline | 267.07 score on a scale | Standard Deviation 119.334 |
| Placebo | Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit | CFB to ODI Course 1 | -104.92 score on a scale | Standard Deviation 261.137 |
Comparison: CFB to Week 18 Course 1p-value: 0.0167Wilcoxon Rank-Sum Test
Comparison: CFB to Week 18 Course 1p-value: 0.1257Wilcoxon Rank-Sum Test
Comparison: CFB to ODI Course 1p-value: 0.9754Wilcoxon Rank-Sum Test
Comparison: CFB to ODI Course 1p-value: 0.7672Wilcoxon Rank-Sum Test
Comparison: CFB to Week 18 Course 2p-value: 0.2232Wilcoxon Rank-Sum Test
Comparison: CFB to Week 18 Course 2p-value: 0.4512Wilcoxon Rank-Sum Test
Comparison: CFB to Course 2 Week 28 FUp-value: 0.3545Wilcoxon Rank-Sum Test
Comparison: CFB to Course 2 Week 28 FUp-value: 0.2482Wilcoxon Rank-Sum Test
Secondary
Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
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 percentage change from Baseline indicates improvement (reduction in bleeding).
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 1 | -96.95 percentage change in PBAC score | Standard Deviation 7.952 |
| Telapristone Acetate 6 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to ODI Course 1 | 33.22 percentage change in PBAC score | Standard Deviation 236.393 |
| Telapristone Acetate 6 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 2 | -98.69 percentage change in PBAC score | Standard Deviation 3.448 |
| Telapristone Acetate 6 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Course 2 Week 28 FU | -55.48 percentage change in PBAC score | Standard Deviation 27.739 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Course 2 Week 28 FU | -81.59 percentage change in PBAC score | Standard Deviation 20.066 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 1 | -94.58 percentage change in PBAC score | Standard Deviation 16.256 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 2 | -100.00 percentage change in PBAC score | Standard Deviation 0 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to ODI Course 1 | 1.41 percentage change in PBAC score | Standard Deviation 85.953 |
| Placebo | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Course 2 Week 28 FU | -99.68 percentage change in PBAC score | Standard Deviation 0.454 |
| Placebo | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to ODI Course 1 | 6.69 percentage change in PBAC score | Standard Deviation 165.599 |
| Placebo | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 2 | -75.00 percentage change in PBAC score | Standard Deviation 29.476 |
| Placebo | Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit | Percentage CFB to Week 18 Course 1 | 59.70 percentage change in PBAC score | Standard Deviation 357.363 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0016Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0003Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to ODI Course 1p-value: 0.6666Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to ODI Course 1p-value: 0.3612Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0309Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0007Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 28 FUp-value: 0.0641Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 28 FUp-value: 0.3743Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -39.29 percentage change in UFS-SSS score | Standard Deviation 31.81 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -87.50 percentage change in UFS-SSS score | Standard Deviation 27.003 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -86.11 percentage change in UFS-SSS score | Standard Deviation 28.26 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -69.44 percentage change in UFS-SSS score | Standard Deviation 37.034 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -95.45 percentage change in UFS-SSS score | Standard Deviation 15.076 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -25.00 percentage change in UFS-SSS score | Standard Deviation 30.046 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -95.83 percentage change in UFS-SSS score | Standard Deviation 14.434 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -83.33 percentage change in UFS-SSS score | Standard Deviation 34.932 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -72.92 percentage change in UFS-SSS score | Standard Deviation 35.6 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -44.79 percentage change in UFS-SSS score | Standard Deviation 31.477 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -57.14 percentage change in UFS-SSS score | Standard Deviation 37.401 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -40.91 percentage change in UFS-SSS score | Standard Deviation 39.167 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0069Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0059Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.2117Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0006Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0788Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.008Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.1516Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.0565Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -95.00 percentage change in UFS-SSS score | Standard Deviation 15.811 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -66.67 percentage change in UFS-SSS score | Standard Deviation 41.458 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -80.56 percentage change in UFS-SSS score | Standard Deviation 34.861 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -54.76 percentage change in UFS-SSS score | Standard Deviation 39.044 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -37.96 percentage change in UFS-SSS score | Standard Deviation 43.123 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -79.44 percentage change in UFS-SSS score | Standard Deviation 41.888 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -88.64 percentage change in UFS-SSS score | Standard Deviation 30.339 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -89.58 percentage change in UFS-SSS score | Standard Deviation 29.113 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -64.58 percentage change in UFS-SSS score | Standard Deviation 41.037 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -38.54 percentage change in UFS-SSS score | Standard Deviation 45.63 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -53.57 percentage change in UFS-SSS score | Standard Deviation 50.428 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -40.91 percentage change in UFS-SSS score | Standard Deviation 62.965 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.011Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0601Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.2168Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0101Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.243Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0843Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.557Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.5302Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -65.63 percentage change in UFS-SSS score | Standard Deviation 69.356 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -18.75 percentage change in UFS-SSS score | Standard Deviation 134.131 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -84.38 percentage change in UFS-SSS score | Standard Deviation 26.517 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -30.56 percentage change in UFS-SSS score | Standard Deviation 73.156 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -18.52 percentage change in UFS-SSS score | Standard Deviation 103.898 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -78.57 percentage change in UFS-SSS score | Standard Deviation 45.844 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -79.55 percentage change in UFS-SSS score | Standard Deviation 60.019 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -56.25 percentage change in UFS-SSS score | Standard Deviation 98.929 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -25.00 percentage change in UFS-SSS score | Standard Deviation 95.743 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -32.29 percentage change in UFS-SSS score | Standard Deviation 57.466 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -55.95 percentage change in UFS-SSS score | Standard Deviation 46.327 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -37.88 percentage change in UFS-SSS score | Standard Deviation 35.622 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0504Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0151Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.5932Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0831Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.1416Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0392Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.8275Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.8733Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -35.71 percentage change in UFS-SSS score | Standard Deviation 149.204 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -14.29 percentage change in UFS-SSS score | Standard Deviation 141.316 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -82.14 percentage change in UFS-SSS score | Standard Deviation 27.817 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -51.67 percentage change in UFS-SSS score | Standard Deviation 38.37 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -45.83 percentage change in UFS-SSS score | Standard Deviation 68.284 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -64.29 percentage change in UFS-SSS score | Standard Deviation 65.57 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -77.50 percentage change in UFS-SSS score | Standard Deviation 62.86 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -52.27 percentage change in UFS-SSS score | Standard Deviation 102.746 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | 0.00 percentage change in UFS-SSS score | Standard Deviation 100 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | 7.14 percentage change in UFS-SSS score | Standard Deviation 103.574 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -38.89 percentage change in UFS-SSS score | Standard Deviation 57.413 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -15.83 percentage change in UFS-SSS score | Standard Deviation 56.988 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0651Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0298Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.4005Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.1114Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.1318Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0807Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.4506Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.4614Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -35.71 percentage change in UFS-SSS score | Standard Deviation 73.396 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -74.07 percentage change in UFS-SSS score | Standard Deviation 25.154 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -82.41 percentage change in UFS-SSS score | Standard Deviation 28.396 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -72.50 percentage change in UFS-SSS score | Standard Deviation 24.861 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -86.36 percentage change in UFS-SSS score | Standard Deviation 30.339 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -29.63 percentage change in UFS-SSS score | Standard Deviation 41.481 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -76.19 percentage change in UFS-SSS score | Standard Deviation 33.31 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -86.36 percentage change in UFS-SSS score | Standard Deviation 30.339 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -58.33 percentage change in UFS-SSS score | Standard Deviation 50 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -56.25 percentage change in UFS-SSS score | Standard Deviation 42.667 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -64.29 percentage change in UFS-SSS score | Standard Deviation 39.002 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -37.50 percentage change in UFS-SSS score | Standard Deviation 48.631 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0653Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.048Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.401Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0772Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.3206Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.1605Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.557Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.3437Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -38.33 percentage change in UFS-SSS score | Standard Deviation 39.323 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -38.89 percentage change in UFS-SSS score | Standard Deviation 48.591 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -49.07 percentage change in UFS-SSS score | Standard Deviation 47.952 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -16.67 percentage change in UFS-SSS score | Standard Deviation 65.793 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -63.89 percentage change in UFS-SSS score | Standard Deviation 48.591 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -46.11 percentage change in UFS-SSS score | Standard Deviation 54.724 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -54.55 percentage change in UFS-SSS score | Standard Deviation 65.017 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -58.33 percentage change in UFS-SSS score | Standard Deviation 63.365 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -80.56 percentage change in UFS-SSS score | Standard Deviation 17.347 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -61.90 percentage change in UFS-SSS score | Standard Deviation 37.223 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -34.72 percentage change in UFS-SSS score | Standard Deviation 73.865 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -2.50 percentage change in UFS-SSS score | Standard Deviation 78.572 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.2624Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0688Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.279Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.6541Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.8559Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.4326Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.1052Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.9206Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -37.50 percentage change in UFS-SSS score | Standard Deviation 32.691 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -43.52 percentage change in UFS-SSS score | Standard Deviation 39.917 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -32.41 percentage change in UFS-SSS score | Standard Deviation 43.789 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -27.38 percentage change in UFS-SSS score | Standard Deviation 63.23 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -52.08 percentage change in UFS-SSS score | Standard Deviation 55.946 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -48.81 percentage change in UFS-SSS score | Standard Deviation 47.237 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -66.67 percentage change in UFS-SSS score | Standard Deviation 66.667 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -69.70 percentage change in UFS-SSS score | Standard Deviation 64.039 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -58.33 percentage change in UFS-SSS score | Standard Deviation 11.785 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -33.33 percentage change in UFS-SSS score | Standard Deviation 52.705 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -61.67 percentage change in UFS-SSS score | Standard Deviation 43.938 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -18.52 percentage change in UFS-SSS score | Standard Deviation 37.68 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.1439Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.067Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.6761Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0639Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.2218Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.4468Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.7678Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.8922Wilcoxon Rank-Sum Test
Secondary
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -61.67 percentage change in UFS-SSS score | Standard Deviation 21.588 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -53.70 percentage change in UFS-SSS score | Standard Deviation 22.864 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -53.70 percentage change in UFS-SSS score | Standard Deviation 19.145 |
| Telapristone Acetate 6 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -42.86 percentage change in UFS-SSS score | Standard Deviation 51.015 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -53.70 percentage change in UFS-SSS score | Standard Deviation 35.627 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -58.89 percentage change in UFS-SSS score | Standard Deviation 53.03 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -70.45 percentage change in UFS-SSS score | Standard Deviation 37.889 |
| Telapristone Acetate 12 mg | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -64.58 percentage change in UFS-SSS score | Standard Deviation 41.458 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -56.25 percentage change in UFS-SSS score | Standard Deviation 34.275 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -43.75 percentage change in UFS-SSS score | Standard Deviation 43.814 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -53.57 percentage change in UFS-SSS score | Standard Deviation 44.32 |
| Placebo | Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -31.82 percentage change in UFS-SSS score | Standard Deviation 51.75 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.1262Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.2075Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.5904Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.243Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.7067Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.2725Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.7016Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.8751Wilcoxon Rank-Sum Test
Secondary
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drug
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 2 | -29.41 percentage change in fibroid volume | Standard Deviation 34.754 |
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to On-Drug Course 2 | -29.41 percentage change in fibroid volume | Standard Deviation 34.754 |
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 1 | -23.61 percentage change in fibroid volume | Standard Deviation 26.553 |
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Course 2 Off-drug | -31.51 percentage change in fibroid volume | Standard Deviation 31.108 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to On-Drug Course 2 | -50.10 percentage change in fibroid volume | Standard Deviation 25.048 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 1 | -38.91 percentage change in fibroid volume | Standard Deviation 20.318 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Course 2 Off-drug | -44.72 percentage change in fibroid volume | Standard Deviation 28.406 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 2 | -50.10 percentage change in fibroid volume | Standard Deviation 25.048 |
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 1 | 1.34 percentage change in fibroid volume | Standard Deviation 18.576 |
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Course 2 Off-drug | -11.26 percentage change in fibroid volume | Standard Deviation 37.048 |
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to Week 18 Course 2 | 11.88 percentage change in fibroid volume | Standard Deviation 56.516 |
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug | Percentage CFB to On-Drug Course 2 | 11.88 percentage change in fibroid volume | Standard Deviation 56.516 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0338Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0004Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0807Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0142Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0807Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.0142Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Off-drugp-value: 0.1859Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Off-drugp-value: 0.0896Wilcoxon Rank-Sum Test
Secondary
Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU 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 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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit
Population: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telapristone Acetate 6 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -70.41 percentage change in UFS-SSS score | Standard Deviation 14.656 |
| Telapristone Acetate 6 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -58.36 percentage change in UFS-SSS score | Standard Deviation 31.193 |
| Telapristone Acetate 6 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -69.17 percentage change in UFS-SSS score | Standard Deviation 24.15 |
| Telapristone Acetate 6 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -33.85 percentage change in UFS-SSS score | Standard Deviation 50.603 |
| Telapristone Acetate 12 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -40.45 percentage change in UFS-SSS score | Standard Deviation 42.753 |
| Telapristone Acetate 12 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -68.46 percentage change in UFS-SSS score | Standard Deviation 31.874 |
| Telapristone Acetate 12 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -80.23 percentage change in UFS-SSS score | Standard Deviation 29.252 |
| Telapristone Acetate 12 mg | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -75.40 percentage change in UFS-SSS score | Standard Deviation 28.158 |
| Placebo | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Course 2 Week 24 FU | -60.53 percentage change in UFS-SSS score | Standard Deviation 36.144 |
| Placebo | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to On-Drug Course 2 | -44.62 percentage change in UFS-SSS score | Standard Deviation 39.429 |
| Placebo | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 2 | -56.65 percentage change in UFS-SSS score | Standard Deviation 38.7 |
| Placebo | Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit | Percentage CFB to Week 18 Course 1 | -32.99 percentage change in UFS-SSS score | Standard Deviation 25.658 |
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0049Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 1p-value: 0.0064Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.5637Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to On-Drug Course 2p-value: 0.0505Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.4262Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Week 18 Course 2p-value: 0.1419Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.4497Wilcoxon Rank-Sum Test
Comparison: Percentage CFB to Course 2 Week 24 FUp-value: 0.5371Wilcoxon Rank-Sum Test
Secondary
Percentage of Participants in Amenorrhea at the End of Treatment Course 2
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.
Time frame: At the end of 18-weeks Treatment Course 2
Population: ITT population consisted of all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telapristone Acetate 6 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 25.00 percentage of participants |
| Telapristone Acetate 12 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 64.71 percentage of participants |
| Placebo | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 0.0 percentage of participants |
p-value: 0.0719Chi-Square Test
p-value: 0.0004Chi-Square Test