Uterine Fibroids
Conditions
Keywords
uterine fibroids, leiomyoma, fibroid tumor, fibroma
Brief summary
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.
Interventions
DRUGPlacebo
Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Telapristone acetate, vaginally, 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
* Adult females between 18 and 47 years. * Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids. * Must have uterine fibroids. * Agreement not to attempt to become pregnant during the trial. * Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited . * Ability to complete a daily Participant diary and study procedures in compliance with the protocol. * Have a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits. * A Body Mass Index (BMI) between 18 and 45 inclusive. * Menstrual blood loss \> 80 milliliters (mL) by alkaline hematin assay.
Exclusion criteria
* Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy. * 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. * History of Polycystic Ovarian Syndrome (PCOS). * Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study. * Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months. * Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months). * Has an Intra Uterine device (IUD) in place. * Known or suspected carcinoma of the breast or reproductive organs. * Recent history (within past 6 months) of alcoholism or drug abuse. * Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 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). |
| 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 | 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 | 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. |
| 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 | 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 | 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 and the Course 2 Week 24 Follow-up Visit | 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 | 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 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 | 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 | 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. |
| 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 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. |
| 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 | 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 | 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 and the Course 2 Week 24 Follow-up Visit | 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 | 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 and the Course 2 Week 24 Follow-up Visit | 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 | 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 and the Course 2 Week 24 Follow-up Visit | 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 | 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 Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2 | The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement. |
| 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 13 |
| 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. | 15 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Course 1 | Adverse Event | 1 | 0 | 1 |
| Treatment Course 1 | Heavy Bleeding | 1 | 1 | 0 |
| Treatment Course 1 | Lost to Follow-up | 1 | 0 | 2 |
| Treatment Course 1 | Withdrawal by Subject | 0 | 2 | 0 |
| Treatment Course 2 | Adverse Event | 1 | 0 | 1 |
| Treatment Course 2 | Lost to Follow-up | 0 | 0 | 1 |
| Treatment Course 2 | Non-compliance | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Telapristone Acetate 6 mg | Telapristone Acetate 12 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 4.53 | 39.4 years STANDARD_DEVIATION 3.55 | 40.9 years STANDARD_DEVIATION 3.31 | 40.6 years STANDARD_DEVIATION 3.82 |
| Race/Ethnicity, Customized Black or African American | 13 Participants | 12 Participants | 14 Participants | 39 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 12 Participants | 12 Participants | 14 Participants | 38 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 15 Participants | 42 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 / 14 | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 13 / 14 | 13 / 13 | 11 / 15 |
| serious Total, serious adverse events | 2 / 14 | 2 / 13 | 2 / 15 |
Outcome results
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.
Time frame: At the end of 18-weeks Treatment Course 1
Population: Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 0.0 percentage of participants |
| Telapristone Acetate 6 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 53.8 percentage of participants |
| Telapristone Acetate 12 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 1 | 46.7 percentage of participants |
p-value: 0.0019Fisher Exact
p-value: 0.0063Fisher Exact
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).
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | -1.21 percentage change in PBAC score | Standard Deviation 100.85 |
| Placebo | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -43.52 percentage change in PBAC score | Standard Deviation 37.967 |
| Telapristone Acetate 6 mg | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | -55.43 percentage change in PBAC score | Standard Deviation 87.522 |
| Telapristone Acetate 6 mg | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -91.02 percentage change in PBAC score | Standard Deviation 18.367 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | -43.85 percentage change in PBAC score | Standard Deviation 82.634 |
| Telapristone Acetate 12 mg | Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -77.42 percentage change in PBAC score | Standard Deviation 34.762 |
Comparison: Percentage change in the last value on drug Course 1.p-value: 0.0145Wilcoxon Rank-Sum Test.
Comparison: Percentage change in the last value on drug Course 1.p-value: 0.0662Wilcoxon Rank-Sum Test.
Comparison: Percentage change in the last value on drug Course 2.p-value: 0.0061Wilcoxon Rank-Sum Test
Comparison: Percentage change in the last value on drug Course 2.p-value: 0.0296Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -21.00 percentage change in UFS-SSS score | Standard Deviation 30.074 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -19.58 percentage change in UFS-SSS score | Standard Deviation 27.672 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -31.67 percentage change in UFS-SSS score | Standard Deviation 41.003 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -55.00 percentage change in UFS-SSS score | Standard Deviation 34.319 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -52.50 percentage change in UFS-SSS score | Standard Deviation 33.811 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -23.89 percentage change in UFS-SSS score | Standard Deviation 31.798 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -53.75 percentage change in UFS-SSS score | Standard Deviation 28.052 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -22.22 percentage change in UFS-SSS score | Standard Deviation 26.471 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -60.50 percentage change in UFS-SSS score | Standard Deviation 27.33 |
Comparison: Percentage Change from BL: Course 1p-value: 0.0473Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.0191Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.0749Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.0233Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.7569Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.5399Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -30.67 percentage change in UFS-SSS score | Standard Deviation 26.646 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -34.03 percentage change in UFS-SSS score | Standard Deviation 28.431 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -45.00 percentage change in UFS-SSS score | Standard Deviation 29.686 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -43.83 percentage change in UFS-SSS score | Standard Deviation 40.484 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -49.03 percentage change in UFS-SSS score | Standard Deviation 36.205 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 6.85 percentage change in UFS-SSS score | Standard Deviation 47.232 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -21.81 percentage change in UFS-SSS score | Standard Deviation 108.137 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 2.78 percentage change in UFS-SSS score | Standard Deviation 116.916 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -45.00 percentage change in UFS-SSS score | Standard Deviation 57.542 |
Comparison: Percentage Change from BL: Course 1p-value: 0.1683Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.256Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.4997Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.1334Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.0323Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.3847Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | 3.70 percentage change in UFS-SSS score | Standard Deviation 62.086 |
| Placebo | 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 | Percentage Change from BL: Course 2 | 38.67 percentage change in UFS-SSS score | Standard Deviation 135.664 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -16.39 percentage change in UFS-SSS score | Standard Deviation 26.178 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -19.33 percentage change in UFS-SSS score | Standard Deviation 55.729 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -26.81 percentage change in UFS-SSS score | Standard Deviation 37.176 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 14.44 percentage change in UFS-SSS score | Standard Deviation 37.118 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | 21.94 percentage change in UFS-SSS score | Standard Deviation 109.882 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 20.00 percentage change in UFS-SSS score | Standard Deviation 45.826 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -21.67 percentage change in UFS-SSS score | Standard Deviation 48.305 |
Comparison: Percentage Change from BL: Course 1p-value: 0.6356Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.9539Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.5219Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.2678Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.3086Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.3847Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | 10.17 percentage change in UFS-SSS score | Standard Deviation 45.443 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -29.31 percentage change in UFS-SSS score | Standard Deviation 25.785 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | 12.22 percentage change in UFS-SSS score | Standard Deviation 84.967 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -40.50 percentage change in UFS-SSS score | Standard Deviation 35.677 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -19.44 percentage change in UFS-SSS score | Standard Deviation 65.452 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -17.41 percentage change in UFS-SSS score | Standard Deviation 38.838 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | 65.28 percentage change in UFS-SSS score | Standard Deviation 136.09 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 97.22 percentage change in UFS-SSS score | Standard Deviation 120.185 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | 51.67 percentage change in UFS-SSS score | Standard Deviation 165.216 |
Comparison: Percentage Change from BL: Course 1p-value: 0.8393Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.1361Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.0382Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.6273Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.8237Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.137Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -33.83 percentage change in UFS-SSS score | Standard Deviation 29.419 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -33.61 percentage change in UFS-SSS score | Standard Deviation 36.054 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -27.22 percentage change in UFS-SSS score | Standard Deviation 42.76 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -36.83 percentage change in UFS-SSS score | Standard Deviation 36.847 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -41.11 percentage change in UFS-SSS score | Standard Deviation 30.939 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -7.04 percentage change in UFS-SSS score | Standard Deviation 49.137 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -53.33 percentage change in UFS-SSS score | Standard Deviation 27.22 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | 0.37 percentage change in UFS-SSS score | Standard Deviation 66.378 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -10.67 percentage change in UFS-SSS score | Standard Deviation 57.811 |
Comparison: Percentage Change from BL: Course 1p-value: 0.7949Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.1928Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 1Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.392Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.541Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.4602Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -17.59 percentage change in UFS-SSS score | Standard Deviation 35.08 |
| Placebo | 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 | Percentage Change from BL: Course 2 | -30.83 percentage change in UFS-SSS score | Standard Deviation 29.4 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -19.72 percentage change in UFS-SSS score | Standard Deviation 32.943 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -8.15 percentage change in UFS-SSS score | Standard Deviation 35.711 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -25.97 percentage change in UFS-SSS score | Standard Deviation 24.365 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -27.50 percentage change in UFS-SSS score | Standard Deviation 32.272 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -17.41 percentage change in UFS-SSS score | Standard Deviation 35.08 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -25.67 percentage change in UFS-SSS score | Standard Deviation 50.511 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -40.28 percentage change in UFS-SSS score | Standard Deviation 26.235 |
Comparison: Percentage Change from BL: Course 1p-value: 0.9536Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.1355Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.9396Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.9102Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.6266Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.9302Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -31.83 percentage change in UFS-SSS score | Standard Deviation 29.819 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -30.83 percentage change in UFS-SSS score | Standard Deviation 26.443 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -36.30 percentage change in UFS-SSS score | Standard Deviation 24.463 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -45.17 percentage change in UFS-SSS score | Standard Deviation 24.999 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -29.03 percentage change in UFS-SSS score | Standard Deviation 32.539 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -33.15 percentage change in UFS-SSS score | Standard Deviation 20.008 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -30.69 percentage change in UFS-SSS score | Standard Deviation 41.209 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -27.59 percentage change in UFS-SSS score | Standard Deviation 39.678 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -7.67 percentage change in UFS-SSS score | Standard Deviation 59.277 |
Comparison: Percentage Change from BL: Course 1p-value: 0.817Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.8177Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.3167Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.5503Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.6929Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.726Wilcoxon 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 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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -28.33 percentage change in UFS-SSS score | Standard Deviation 25.784 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -30.42 percentage change in UFS-SSS score | Standard Deviation 27.174 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -27.59 percentage change in UFS-SSS score | Standard Deviation 27.299 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -32.33 percentage change in UFS-SSS score | Standard Deviation 28.976 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -40.69 percentage change in UFS-SSS score | Standard Deviation 29.759 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -22.59 percentage change in UFS-SSS score | Standard Deviation 19.421 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 1 | -38.33 percentage change in UFS-SSS score | Standard Deviation 65.308 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change: Course 2, Week 24 Follow-up | -12.22 percentage change in UFS-SSS score | Standard Deviation 29.059 |
| 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 and the Course 2 Week 24 Follow-up Visit | Percentage Change from BL: Course 2 | -27.50 percentage change in UFS-SSS score | Standard Deviation 37.509 |
Comparison: Percentage Change from BL: Course 1p-value: 0.3896Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.1358Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.7903Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.8206Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.7891Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2, Week 24 Follow-up Visitp-value: 0.401Wilcoxon Rank-Sum Test
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.
Time frame: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | 1.41 percentage change in fibroid volume | Standard Deviation 31.115 |
| Placebo | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -3.72 percentage change in fibroid volume | Standard Deviation 31.316 |
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | -28.26 percentage change in fibroid volume | Standard Deviation 26.705 |
| Telapristone Acetate 6 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -36.39 percentage change in fibroid volume | Standard Deviation 40.892 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 1 | -13.84 percentage change in fibroid volume | Standard Deviation 29.167 |
| Telapristone Acetate 12 mg | Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2 | Percentage Change from BL: Course 2 | -13.06 percentage change in fibroid volume | Standard Deviation 42.234 |
Comparison: Percentage Change from BL: Course 1p-value: 0.0294Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.1934Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.0442Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.8314Wilcoxon Rank-Sum Test
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Percentage Change from BL: Course 2 | -31.11 percentage change in UFS-SSS score | Standard Deviation 33.577 |
| Placebo | 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 | Percentage Change from BL: Course 1 | -33.54 percentage change in UFS-SSS score | Standard Deviation 30.981 |
| Placebo | 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 | Percentage Change: Course 2, Week 24 Follow-up | -37.38 percentage change in UFS-SSS score | Standard Deviation 30.153 |
| Telapristone Acetate 6 mg | 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 | Percentage Change from BL: Course 2 | -43.69 percentage change in UFS-SSS score | Standard Deviation 35.919 |
| Telapristone Acetate 6 mg | 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 | Percentage Change from BL: Course 1 | -49.68 percentage change in UFS-SSS score | Standard Deviation 37.927 |
| Telapristone Acetate 6 mg | 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 | Percentage Change: Course 2, Week 24 Follow-up | -26.90 percentage change in UFS-SSS score | Standard Deviation 26.126 |
| Telapristone Acetate 12 mg | 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 | Percentage Change from BL: Course 1 | -42.27 percentage change in UFS-SSS score | Standard Deviation 45.842 |
| Telapristone Acetate 12 mg | 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 | Percentage Change: Course 2, Week 24 Follow-up | -14.66 percentage change in UFS-SSS score | Standard Deviation 41.842 |
| Telapristone Acetate 12 mg | 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 | Percentage Change from BL: Course 2 | -37.98 percentage change in UFS-SSS score | Standard Deviation 46.287 |
Comparison: Percentage Change from BL: Course 1p-value: 0.2642Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 1p-value: 0.4383Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.5333Wilcoxon Rank-Sum Test
Comparison: Percentage Change from BL: Course 2p-value: 0.8791Wilcoxon Rank-Sum Test
Comparison: Percentage Change: Course 2, Week 24 Follow-upp-value: 0.3666Wilcoxon Rank-Sum Test
Comparison: Percentage Change: Course 2, Week 24 Follow-upp-value: 0.345Wilcoxon Rank-Sum Test
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.
Time frame: At the end of 18-weeks Treatment Course 2
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 7.1 percentage of participants |
| Telapristone Acetate 6 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 46.2 percentage of participants |
| Telapristone Acetate 12 mg | Percentage of Participants in Amenorrhea at the End of Treatment Course 2 | 46.7 percentage of participants |
p-value: 0.0237Fisher Exact
p-value: 0.0272Fisher Exact