Phase 2
N=43
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Uterine Fibroids
Bottom Line
View on ClinicalTrials.gov: NCT02301897 ↗Enrolled (actual)
43
Serious AEs
4.7%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Participants in Amenorrhea at the End of Treatment Course 1 — 58.33; 70.59; 0.0 percentage of participants — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Telapristone Acetate (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Repros Therapeutics Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Amenorrhea at the End of Treatment Course 1 |
58.33; 70.59; 0.0 | 0.0008 sig |
| SECONDARY Percentage of Participants in Amenorrhea at the End of Treatment Course 2 |
25.00; 64.71; 0.0 | 0.0719 |
| 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 |
316.82; 371.20; 267.07; -340.61; -364.55; -44.48 | 0.0167 sig |
| 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 |
-96.95; -94.58; 59.70; 33.22; 1.41; 6.69 | 0.0016 sig |
| 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 |
-70.41; -68.46; -32.99; -58.36; -75.40; -44.62 | 0.0049 sig |
| 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 |
-87.50; -83.33; -40.91; -69.44; -95.83; -44.79 | 0.0069 sig |
| 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 |
-95.00; -79.44; -40.91; -66.67; -89.58; -38.54 | 0.0110 sig |
| 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 |
-65.63; -78.57; -37.88; -18.75; -56.25; -32.29 | 0.0504 |
| 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 |
-35.71; -64.29; -15.83; -14.29; -52.27; 7.14 | 0.0651 |
| 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 |
-72.50; -76.19; -37.50; -74.07; -86.36; -56.25 | 0.0653 |
| 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 |
-38.33; -46.11; -2.50; -38.89; -58.33; -61.90 | 0.2624 |
| 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 |
-37.50; -48.81; -18.52; -43.52; -69.70; -33.33 | 0.1439 |
| 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 |
-61.67; -58.89; -31.82; -53.70; -64.58; -43.75 | 0.1262 |
| 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 |
-23.61; -38.91; 1.34; -29.41; -50.10; 11.88 | 0.0338 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02301897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.